NUTRA PHARMA : Management’s Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q)

Introduction

Our business during the first quarter of 2021 has focused upon marketing our
homeopathic drugs for the treatment of pain:

?Nyloxin® (Stage 2 Pain)

?Nyloxin® Extra Strength (Stage 3 Pain)

?Pet Pain-Away

?Equine Pain-Away

? Luxury Feet

During our first quarter of 2021 and thereafter, the following has occurred:

On February 12, 2021 we announced that we are focusing on our intellectual
property portfolio and have engaged new IP attorneys at Christopher & Weisberg
P.A.

On February 23, 2021 we provided updates on our work in improving our existing
facilities for manufacturing and validation of our drug products. This included
the renewal of our lease for our current lab space and bringing all of
manufacturing in-house.

On March 11, 2021 we announced that we had engaged AccuReg, Inc. as outside
Regulatory and Quality Assurance consultants as part of our work in improving
our existing facilities for manufacturing and validation of our drug products.

On March 16, 2021 we announced our plans for the marketing and distribution of
Luxury Feet; an over-the-counter pain reliever and anti-inflammatory product
that is designed for women who experience pain or discomfort due to high heels
and stilettos.

On April 15, 2021 we announced that our newest product, Luxury Feet, was
available for purchase on Amazon.com.

On May 24, 2021, we announced plans for expanding the marketing of our
over-the-counter pain relievers and anti-inflammatory products by working with
influencers on several social media platforms. These will include celebrities as
well as professional and Olympic athletes that have benefitted from our
products.

On May 27, 2021, we provided updates on increasing our manufacturing
capabilities for the production of our line of over-the-counter pain relievers
and anti-inflammatory drugs. As part of this process, we have completed the
design and purchase for a new liquid filling line that includes automatic
filling, capping, coding, labeling and heat shrinking for most of our products.

The new equipment will allow production of up to 40 bottles per minute, which
greatly increases our manufacturing capacity. The equipment was validated,
certified and in production in August of 2021.

On June 2, 2021, we announced that we had signed an agreement with professional
snowboarder Jake Vedder as a celebrity endorser of Nyloxin for Chronic Pain
relief. Mr. Vedder will provide marketing content, videos and testimonials on
the use of our product and as a social media influencer.

On June 4, 2021, we announced our plans for increasing sales of our
over-the-counter pain relievers through private label agreements that will
rebrand Nyloxin. The first private label distributor contract has been executed
with sales expected to start within the next 4-6 weeks. Their marketing plan
includes direct sales, targeted landing pages and aggressive marketing through
social media.

On June 8, 2021, we announced that Diverse Health Services of Metro-Detroit has
added the Nyloxin line of products to their offerings. Nyloxin is already being
sold in-house at their facilities and will be added shortly to their online
marketplace. Their marketing plan includes direct sales to patients and other
medical facilities, sales through their websites and social media utilizing
their online platforms as well as videos featuring Dr. Randall Tent.

On July 15, 2021, we announced that we had engaged the Washington DC-based
government affairs consulting firm, Vitello Consulting. The firm will work with
elected officials as well as governmental agencies to increase the awareness of
Nutra Pharma’s products and technologies with the goal of improving sales,
garnering grants and potentially speeding drug applications.

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On July 23, 2021, we announced that we filed a new provisional patent to protect
our intellectual property surrounding our development of nerve agent counter
measures.

Nyloxin®/Nyloxin® Extra Strength

We offer Nyloxin®/Nyloxin® Extra Strength as our over-the-counter (OTC) pain
reliever that has been clinically proven to treat moderate to severe (Stage 2)
chronic pain.

Nyloxin® and Nyloxin® Extra Strength are available as a two ounce topical gel
for treating joint pain and pain associated with arthritis and repetitive
stress, and as a one ounce oral spray for treating lower back pain, migraines,
neck aches, shoulder pain, cramps, and neuropathic pain. Both the topical gel
and oral spray are packaged and sold as a one-month supply.

Nyloxin® and Nyloxin® Extra Strength offer several benefits as a pain reliever.
With increasing concern about consumers using opioid and acetaminophen-based
pain relievers, the Nyloxin® products provide an alternative that does not rely
on opiates or non-steroidal anti-inflammatory drugs, otherwise known as NSAIDs,
for their pain relieving effects. Nyloxin® also has a well-defined safety
profile. Since the early 1930s, the active pharmaceutical ingredient (API) of
Nyloxin®, Asian cobra venom, has been studied in more than 46 human clinical
studies. The data from these studies provide clinical evidence that cobra venom
provides an effective treatment for pain with few side effects and has the
following benefits:

?safe and effective;

?all natural;

?long-acting;

?easy to use;

?non-narcotic;

?non-addictive; and

?analgesic and anti-inflammatory.

Potential side effects from the use of Nyloxin® are rare, but may include
headache, nausea, vomiting, sore throat, allergic rhinitis and coughing.

The primary difference between Nyloxin® and Nyloxin® Extra Strength is the
dilution level of the venom. The approximate dilution levels for Nyloxin® and
Nyloxin® Extra Strength are as follows:

Nyloxin®

?Topical Gel: 30 mcg/mL

?Oral Spray: 70 mcg/mL

Nyloxin® Extra Strength

?Topical Gel: 60 mcg/mL

?Oral Spray: 140 mcg/mL

In December 2011, we began marketing Nyloxin® and Nyloxin® Extra Strength at
http://www.nyloxin.com and on http://www.Amazon.com/nyloxin. Both Nyloxin® and Nyloxin®Extra
Strength are packaged in a roll-on container, squeeze bottle and as an oral
spray. Additionally, Nyloxin® topical gel is available in an 8 ounce pump
bottle.

We are currently marketing Nyloxin® and Nyloxin® Extra Strength as treatments
for moderate to severe chronic pain. Nyloxin® is available as an oral spray for
treating back pain, neck pain, headaches, joint pain, migraines, and neuralgia
and as a topical gel for treating joint pain, neck pain, arthritis pain, and
pain associated with repetitive stress. Nyloxin® Extra Strength is available as
an oral spray and gel application for treating the same physical indications,
but is aimed at treating the most severe (Stage 3) pain that inhibits one’s
ability to function fully.

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Nyloxin® Military Strength

In December 2012, we announced the availability of Nyloxin® Military Strength
for sale to the United States Military and Veteran’s Administration. Over the
past few years, the U.S. Department of Defense has been reporting an increase in
the use and abuse of prescription medications, particularly opiates. In 2009,
close to 3.8 million prescriptions for pain relievers were written in the
military. This staggering number was more than a 400% increase from the number
of prescriptions written in the military in 2001. But prescription drugs are not
the only issue. The most common and seemingly harmless way to treat pain is with
non-steroidal, anti-inflammatory drugs (NSAIDS). But there are risks. Overuse
can cause nausea, vomiting, diarrhea, heartburn, ulcers and internal bleeding.
In severe cases chest pain, heart failure, kidney dysfunction and
life-threatening allergic reactions can occur. It is reported that approximately
7,600 people in America die from NSAID use and some 78,000 are hospitalized.
Ibuprofen, also an NSAID has been of particular concern in the military. The
terms “Ranger Candy” and “Military Candy” refer to the service men and women who
are said to use 800mg doses of Ibuprofen to control their pain. But when taking
anti-inflammatory Ibuprofen in high doses for chronic pain, there is potential
for critical health risks; abuse can lead to serious stomach problems, internal
bleeding and even kidney failure. There are significantly greater health risks
when abuse of this drug is combined with alcohol intake. Our goal is that with
Nyloxin®, we can greatly reduce the instances of opiate abuse and overuse of
NSAIDS in high risk groups like the US military. The Nyloxin® Military Strength
represents the strongest version of Nyloxin® available and is approximately
twice as strong as Nyloxin® Extra Strength. We are working with outside
consultants to register Nyloxin® Military Strength and the other Nyloxin®
products for sale to the US government and the various arms of the military as
well as the Veteran’s Administration. In February of 2018, Nyloxin was added to
the Federal Supply Schedule but was subsequently removed the following week
without an adequate explanation. We have continued to work with our consultants
to understand why our products were improperly removed the Federal Supply
Schedule and when we may be able to get re-listed on the Federal Supply Schedule
for eventual sales to governmental agencies or to the US Military.

International Sales

We are pursuing international drug registrations in Canada, Mexico, India,
Australia, New Zealand, Central and South America and Europe. Since European
rules for homeopathic drugs are different than the rules in the US, we cannot
estimate when this process will be completed. On March 25, 2013 we announced the
publication of our patent and trademark for Nyloxin® in India. We are actively
seeking new distribution partners in India.

On May 14, 2015 we announced that we had engaged the Nature’s Clinic to begin
the process of regulatory approval of our Company’s Over-the-Counter pain drug,
Nyloxin® for marketing and distribution in Canada. The Nature’s Clinic has
already begun setting up their Chatham, Ontario warehouse. Due to lack of
funding, we have waited to complete the approval process to begin distributing
Nyloxin® and expect to re-engage in the process in 2021.

On February 1, 2018 we announced a Distribution Agreement with the Australian
company, Pharmachal PTY LTD to market and distribute Nyloxin® in Australia and
New Zealand. Pharmachal has begun the registration process with the TGA
(Therapeutic Goods Administration). At this time, we do not know if our products
will qualify for TGA registration and cannot provide a timeline for the eventual
distribution in Australia.

Additionally, we plan to complete several human clinical studies aimed at
comparing the ability of Nyloxin® Extra Strength to replace prescription pain
relievers. We have provided protocols to several hospitals and will provide
details and timelines when those protocols have been accepted. We cannot provide
any timeline for these studies until adequate financing is available.

To date, our marketing efforts have been limited due to lack of funding. As
sales increase, we plan to begin marketing more aggressively to increase the
sales and awareness of our products.

Pet Pain-Away

During June of 2013, we announced the launch of our new homeopathic formula for
the treatment of chronic pain in companion animals, Pet Pain-Away™. Pet
Pain-Away™ is a homeopathic, non-narcotic, non-addictive, over-the-counter pain
reliever, primarily aimed at treating moderate to severe chronic pain in
companion animals. It is specifically indicated to treat pain from hip
dysplasia, arthritis pain, joint pain, and general chronic pain in dogs and
cats. The initial product run was completed in December of 2014 and launched
through Lumaxa Distributors on December 19, 2014.

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In May of 2016, we signed a license agreement to begin the process of creating
an infomercial (Direct Response) campaign for Pet Pain-Away™. In November of
2016, we announced the license agreement with DEG Productions for the marketing
and distribution of Pet Pain-Away globally. DEG has the ability to earn the
exclusive distribution rights for the product by reaching certain sales
milestones. DEG has created their own website (www.getpetpainaway.com) and began
airing commercials in December of 2016.

In February of 2020, we took back the marketing of Pet Pain-Away and are
currently selling the product on Amazon.com and through http://www.petpainaway.com.

Luxury Feet

In June of 2017 we announced the creation of Luxury Feet; an over-the-counter
pain reliever and anti-inflammatory product that is designed for women who
experience pain or discomfort due to high heels and stilettos. In March of 2021
we announced plans for the marketing and distribution of Luxury Feet and on
April 15, 2021 we announced that the product was available for purchase on
Amazon. We will continue with the marketing efforts of Luxury Feet throughout
2021 with plans to start social media campaigns and a retail rollout later in
the year.

Equine Pain-Away (Formerly Equine Nyloxin)

In October of 2013, we announced that we were in the process of launching the
newest addition to our line of homeopathic treatments for chronic pain, Equine
Nyloxin. We had been working with trainers and veterinarians in the equine
industry and have already identified distributors for the product. The Equine
Nyloxin® represents the Company’s first topical solution for the animal market.
Equine Nyloxin was rebranded as Equine Pain-Away and officially rolled into the
market in October of 2019. Equine Pain-Away is being marketed through several
retailers and online at http://www.EquinePainAway.com and on Amazon.

Drug Discovery and Pipeline

Nutra Pharma is developing proprietary therapeutic protein products for the
biologics market. The Company has two leading drug candidates: RPI-MN and
RPI-78M.

RPI-MN

RPI-MN inhibits the entry of several viruses that are known to cause severe
neurological damage in such diseases as encephalitis and Human Immunodeficiency
Virus (HIV). It is being developed first for the treatment of HIV.

RPI-78M

RPI-78M is being developed for the treatment of Multiple Sclerosis (MS) and
Adrenomyeloneuropathy (AMN). Other neurological and autoimmune disorders that
may be served by RPI-78M include Myasthenia Gravis (MG), Rheumatoid Arthritis
(RA) and Amyotrophic Lateral Sclerosis (ALS).

RPI-78M and RPI-MN contain anticholinergic peptides that recognize the same
receptors as nicotine (acetylcholine receptors) but have the opposite effect. In
a specific chemical process unique to Nutra Pharma, the drugs are created
through a process of chemical modification.

In September, 2015 RPI-78M was granted Orphan Status by the FDA for the
treatment of pediatric Multiple Sclerosis. This allows for much shorter
timelines to drug approval, waiver of FDA fees (around $2.5M), rolling review
and fast-track approval. Orphan status also allows for potential grant money and
other funding opportunities through the clinical process.

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RPI-MN and RPI-78M possess several desirable properties as drugs:

? They lack measurable toxicity but are still capable of attaching to and
affecting the target site on the nerve cells. This means that patients cannot
overdose.

? They display no serious adverse side effects following years of investigations
in humans and animals.

? They are extremely stable and resistant to heat, which gives the drugs a long
shelf life. The drugs’ stability has been determined to be over 4 years at room
temperature. This is extremely unusual for a biologic drug.

? RPI-78M may be administered orally — a first for a biologic MS drug. This
will present MS patients with additional quality of life benefits by eliminating
the requirement for routine injections.

? They are easy to administer.

We are currently working with consultants to develop trial protocols for a Phase
I/II trial for the use of RPI-78M in the treatment of Pediatric Multiple
Sclerosis. We expect to begin the trial in FY2021.

Critical Accounting Policies and Estimates

Our condensed consolidated unaudited financial statements and accompanying notes
have been prepared in accordance with accounting principles generally accepted
in the United States (“GAAP”) applied on a consistent basis. The preparation of
financial statements in conformity with GAAP requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities, the disclosure of contingent assets and liabilities at the date of
the financial statements and the reported amounts of revenues and expenses
during the reporting periods.

We regularly evaluate the accounting policies and estimates that we use to
prepare our condensed consolidated financial statements. In general,
management’s estimates are based on historical experience, information from
third party professionals, and various other assumptions that are believed to be
reasonable under the facts and circumstances. Actual results could differ from
those estimates made by management under different and/or future circumstances.

We believe that our critical accounting policies and estimates include our
ability to continue as a going concern, revenue recognition, accounts receivable
and allowance for doubtful accounts, inventory obsolescence, accounting for
long-lived assets and accounting for stock based compensation.

Ability to Continue as a Going Concern: Our ability to continue as a going
concern is contingent upon our ability to secure additional financing, increase
ownership equity, and attain profitable operations. In addition, our ability to
continue as a going concern must be considered in light of the problems,
expenses and complications frequently encountered in established markets and the
competitive environment in which we operate.

Revenue Recognition: The Company accounts for revenue from contracts with
customers in accordance with Financial Accounting Standard Board (“FASB”)
Accounting Standard Codification (“ASC”) Topic 606, Revenue from Contracts with
Customers (“ASC 606”). Under ASC Topic 606, revenue recognition has a five-step
process: a) Determine whether a contract exists; b) Identify the performance
obligations; c) Determine the transaction price; d) Allocate the transaction
price; and e) Recognize revenue when (or as) performance obligations are
satisfied.

Our revenues are primarily derived from customer orders for the purchase of our
products. We recognize revenues as performance obligations are fulfilled when
control passes to our customers. We record revenues net of promotions and
discounts. For certain product sales to a distributor, we record revenue
including a portion of the cash proceeds that is remitted back to the
distributor.

Accounts Receivable and Allowance for Doubtful Accounts: We grant credit without
collateral to our customers based on our evaluation of a particular customer’s
credit worthiness. Accounts receivable are due 30 days after the issuance of the
invoice. In addition, allowances for doubtful accounts are maintained for
potential credit losses based on the age of the accounts receivable and the
results of periodic credit evaluations of our customers’ financial condition.
Accounts receivable are written off after collection efforts have been deemed to
be unsuccessful. Accounts written off as uncollectible are deducted from the
allowance for doubtful accounts, while subsequent recoveries are netted against
the provision for doubtful accounts expense. We generally do not charge interest
on accounts receivable. We use third party payment processors and are required
to maintain reserve balances, which are included in accounts receivable.

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Our accounts receivable are stated at estimated net realizable value. Accounts
receivable are comprised of balances due from customers net of estimated
allowances for uncollectible accounts. In determining collectability, historical
trends are evaluated and specific customer issues are reviewed to arrive at
appropriate allowances.

Inventory Obsolescence: Inventories are valued at the lower of average cost or
market value. We periodically perform an evaluation of inventory for excess,
impairments and obsolete items. At March 31, 2021, our inventory consisted
entirely of raw materials and finished goods that are utilized in the
manufacturing of finished goods. These raw materials generally have expiration
dates in excess of 10 years. We classify inventory as short-term or long-term
inventory based on timing of when it is expected to be consumed.

Long-Lived Assets: The carrying value of long-lived assets is reviewed annually
and on a regular basis for the existence of facts and circumstances that may
suggest impairment. If indicators of impairment are present, we determine
whether the sum of the estimated undiscounted future cash flows attributable to
the long-lived asset in question is less than its carrying amount. If less, we
measure the amount of the impairment based on the amount that the carrying value
of the impaired asset exceeds the discounted cash flows expected to result from
the use and eventual disposal of the impaired assets.

Derivative Financial Instrument: Management evaluates all of its financial
instruments to determine if such instruments are derivatives or contain features
that qualify as embedded derivatives. For derivative financial instruments that
are accounted for as liabilities, the derivative instrument is initially
recorded at its fair value and is then re-valued at each reporting date, with
changes in the fair value reported as charges or credits to income. For
option-based simple derivative financial instruments, the Company uses the
Black-Scholes option-pricing model to value the derivative instruments at
inception and subsequent valuation dates. The classification of derivative
instruments, including whether such instruments should be recorded as
liabilities or as equity, is re-assessed at the end of each reporting period.
Derivative instrument liabilities are classified in the balance sheet as current
or non-current based on whether or not net-cash settlement of the derivative
instrument could be required within 12 months of the balance sheet date.

We do not use derivative instruments to hedge exposures to cash flow, market, or
foreign currency risks.

Convertible Debt: For convertible debt that does not contain an embedded
derivative that requires bifurcation, the conversion feature is evaluated to
determine if the rate of conversion is below market value and should be
categorized as a beneficial conversion feature (“BCF”). A BCF related to debt is
recorded by the Company as a debt discount and with the offset recorded to
equity. The related convertible debt is recorded net of the discount for the
BCF. The discount is amortized as additional interest expense over the term of
the debt with the resulting debt discount being accreted over the term of the
note.

The Fair Value Measurement Option: We have elected the fair value measurement
option for convertible debt with embedded derivatives that require bifurcation,
and record the entire hybrid financing instrument at fair value under the
guidance of ASC Topic 815, Derivatives and Hedging (“ASC Topic 815”). The
Company reports interest expense, including accrued interest, related to this
convertible debt under the fair value option, within the change in fair value of
convertible notes and derivatives in the accompanying consolidated statement of
operations.

Derivative Accounting for Convertible Debt and Options and Warrants: The Company
evaluated the terms and conditions of the convertible debt under the guidance of
ASC 815, Derivatives and Hedging. The conversion terms of some of the
convertible notes are variable based on certain factors, such as the future
price of the Company’s common stock. The number of shares of common stock to be
issued is based on the future price of the Company’s common stock. The number of
shares of common stock issuable upon conversion of the debt is indeterminate.
Due to the fact that the number of shares of common stock issuable could exceed
the Company’s authorized share limit, the equity environment is tainted, and all
additional convertible debt and options and warrants are included in the value
of the derivative liabilities. Pursuant to ASC 815-15, Embedded Derivatives, the
fair values of the convertible debt, options and warrants and shares to be
issued were recorded as derivative liabilities on the issuance date and revalued
at each reporting period.

Share-Based Compensation: We record share-based compensation in accordance with
FASB ASC 718, Stock Compensation. FASB ASC 718 requires that the cost resulting
from all share-based transactions are recorded in the financial statements over
the respective service periods. It establishes fair value as the measurement
objective in accounting for share-based payment arrangements and requires all
entities to apply a fair-value-based measurement in accounting for share-based
payment transactions with employees. FASB ASC 718 also establishes fair value as
the measurement objective for transactions in which an entity acquires goods or
services from non-employees in share-based payment transactions.

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Results of Operations – Comparison of Three Months Periods Ended March 31, 2021
and March 31, 2020

Sales for the three-month period ended March 31, 2021 were $22,023 compared to
$17,116 for the three-month period ended March 31, 2020. The increase in net
sales is primarily attributable to the increase in Pet Pain-Away sales.

Cost of sales for the three-month period ended March 31, 2021 is $5,634 compared
to $5,279 for the three-month period March 31, 2020. Our cost of sales includes
the direct costs associated with manufacturing, shipping and handling costs. Our
gross profit margin for the three-month period ended March 31, 2021 is $16,389
or 74.42% compared to $11,837 or 69.16% for the three-month period ended March
31, 2020. The increase in our profit margin is primarily due to decrease in the
manufacturing cost.

Selling, general and administrative expenses (“SG&A”) increased $266,151 or
111.62% from $238,441 for the quarter ended March 31, 2020 to $504,592 for the
quarter ended March 31, 2021, generally due to the overall increase in
professional fees. In addition, we incurred bad debt expense of $53,000 from the
receivables from companies owned by the Company’s CEO for the three months ended
March 31, 2021. We had a bad debt recovery from the receivables from companies
owned by the Company’s CEO for $39,500 for the three months ended March 31,
2020.

Interest expense, including related party interest expense, increased $42,691 or
58.01%, from $73,594 for the quarter ended March 31, 2020 to $116,285 for the
quarter ended March 31, 2021. This increase was primarily due to increase in
amortization of loan discounts in the quarter ended March 31, 2021 compared to
the quarter ended March 31, 2020.

We carry a convertible notes receivable obtained during the first quarter of
2021 at fair value. For the three months ended March 31, 2021, the unrealized
gain is $43,899.

We carry certain of our debentures and common stock warrants at fair value. For
the three months ended March 31, 2021 and 2020, the liability related to these
hybrid instruments fluctuated, resulting in a loss of $32,876,870 and a gain of
$2,542,942, respectively.

Loss on settlement of debts increased $396,297 or 1,801.35%, from a loss of
$22,000 for the three months ended March 31, 2020 to a loss of $418,297 for the
three months ended March 31, 2021. This increase was primarily due to increase
in losses on settlement of debt through issuance of shares of common stock.
Stock issued for loan modification increased $30,300 or 39.25% from $77,200 for
the three months ended March 31, 2020 to $107,500 for the three months ended
March 31, 2021.

As a result of the foregoing, our net income/loss decreased by $36,199,300 or
1,658.20%, from income of $2,183,044 for the quarter ended March 31, 2020 to a
loss of $34,016,256 for the quarter ended March 31, 2021.

Liquidity and Capital Resources

We have incurred significant losses from operations and working capital and
stockholders’ deficits raise substantial doubt about our ability to continue as
a going concern. Further, as stated in Note 1 to our condensed consolidated
unaudited financial statements for the period ended March 31, 2021, we have an
accumulated deficit of $102,649,724 at March 31, 2021. In addition, we have a
significant amount of indebtedness in default, a working capital deficit of
$41,220,790 and a stockholders’ deficit of $42,854,404 at March 31, 2021.

Our ability to continue as a going concern is contingent upon our ability to
secure additional financing, increase ownership equity, and attain profitable
operations. In addition, our ability to continue as a going concern must be
considered in light of the problems, expenses and complications frequently
encountered in established markets and the competitive environment in which we
operate. As of the date of the filing of this report, we do not believe that our
source of cash is adequate for the next 12 months of operation and there is
substantial doubt about our ability to continue as a going concern.

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Historically, we have relied upon loans from our Chief Executive Officer, Rik
Deitsch, to fund our operations. At March 31, 2021, the balance due to our
President and CEO, Rik Deitsch, is $196,643, which is an unsecured demand loan
that bears interest at 4%. Additionally, accrued interest on the demand loan was
$1,956 and is included in the due to officer account.

During the three months ended March 31, 2021, we raised $719,058 through the
issuance of convertible notes. Current operations are being funded through a
combination of product sales, loans from our CEO and convertible notes.

We expect to utilize the proceeds from these funds and additional capital to
manufacture Nyloxin® and Pet Pain-Away and reduce our debt level. We estimate
that we will require approximately $200,000 quarterly to fund our existing
operations and ReceptoPharm’s operations for the next twelve months from the
date of filing. These costs include: (i) compensation for three (3) full-time
employees; (ii) compensation for various consultants who we deem critical to our
business; (iii) general office expenses including rent and utilities; (iv)
product liability insurance; and (v) outside legal and accounting services.
These costs reflected in (i) – (v) do not include research and development costs
or other costs associated with clinical studies.

We began generating revenues from the sale of Cobroxin® in the fourth quarter of
2009 and from the sale of Nyloxin® during the first quarter of 2011. We began
generating revenues from the sale of Pet Pain-Away™ in the fourth quarter of
2014. Our ability to meet our future operating expenses is highly dependent on
the amount of such future revenues. To the extent that future revenues from the
sales of Nyloxin® and Pet Pain-Away™ are insufficient to cover our operating
expenses we may need to raise additional equity capital, which could result in
substantial dilution to existing shareholders. There can be no assurance that we
will be able to raise sufficient equity capital to fund our working capital
requirements on terms acceptable to us, or at all. We may also seek additional
loans from our officers and directors; however, there can be no assurance that
we will be successful in securing such additional loans.

Impact of COVID-19 on our Operations

The ramifications of the outbreak of the novel strain of COVID-19 are filled
with uncertainty and changing quickly. Our operations have continued during the
COVID-19 pandemic and we have not had significant disruption. Beginning in June
2020, the Company experienced a delay in retail rollout as a downstream
implication of the slowing economy. We also closed our Coral Springs office in
effort to save money. During May 2020, we received approval from SBA to fund our
request for a PPP loan for $64,895. We used the proceeds primarily for payroll
costs. We expect forgiveness of this loan under the current terms of requirement
by the SBA. During April and June 2020, we obtained the loan in the amount of
$150,000 from SBA under its Economic Injury Disaster Loan assistance program. We
used the proceeds primarily for rent, payroll, utilities, accounting and legal
expenses.

The Company is operating in a rapidly changing environment so the extent to
which COVID-19 impacts its business, operations and financial results from this
point forward will depend on numerous evolving factors that the Company cannot
accurately predict. Those factors include the following: the duration and scope
of the pandemic; governmental, business and individuals’ actions that have been
and continue to be taken in response to the pandemic; and the distribution of
testing and a vaccine.

Uncertainties and Trends

Our operations and possible revenues are dependent now and in the future upon
the following factors:

?whether Nyloxin®, Nyloxin® Extra Strength and Pet Pain-Away will be accepted by
retail establishments where they are sold;

?because Nyloxin® is a novel approach to the over-the-counter pain market,
whether it will be accepted by consumers over conventional over-the-counter pain
products;

?whether Nyloxin® Military Strength will be successfully launched and be
accepted in the marketplace;

?whether our international drug applications will be approved and in how many
countries;

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?whether we will be successful in marketing Nyloxin®, Nyloxin® Extra Strength
and Pet Pain-Away in our target markets and create nationwide and international
visibility for our products;

?whether our drug delivery system, i.e. oral spray and gel, will be accepted by
consumers who may prefer a pain pill delivery system;

?whether competitors’ pain products will be found to be more attractive to
consumers;

?whether we successfully develop and commercialize products from our research
and development activities;

?whether we compete effectively in the intensely competitive biotechnology area;

?whether we successfully execute our planned partnering and out-licensing
products or technologies;

?whether the current economic downturn and related credit and financial market
crisis will adversely affect our ability to obtain financing, conduct our
operations and realize opportunities to successfully bring our technologies to
market;

?whether we are subject to litigation and related costs in connection with use
of products;

?whether we will successfully contract with domestic
distributor(s)/advertiser(s) for our products and whether that will cause
interruptions in our operations;

?whether we comply with FDA and other extensive legal/regulatory requirements
affecting the healthcare industry.

Off-Balance Sheet Arrangements

We have not entered into any transaction, agreement or other contractual
arrangement with an entity unconsolidated with us under whom we have:

?An obligation under a guarantee contract.

?A retained or contingent interest in assets transferred to the unconsolidated
entity or similar arrangement that serves as credit, liquidity or market risk
support to such entity for such assets.

?Any obligation, including a contingent obligation, under a contract that would
be accounted for as a derivative instrument.

?Any obligation, including a contingent obligation, arising out of a variable
interest in an unconsolidated entity that is held by us and material to us where
such entity provides financing, liquidity, market risk or credit risk support
to, or engages in leasing, hedging or research and development services with us.

We do not have any off-balance sheet arrangements or commitments other than
those disclosed in this report that have a current or future effect on its
financial condition, changes in financial condition, revenues or expenses,
results of operations, liquidity, capital expenditures, or capital resources
that is material.

© Edgar Online, source Glimpses

The following post NUTRA PHARMA : Management’s Discussion and Analysis of Financial Condition and Results of Operations (form 10-Q) is available on https://americanchiropractors.org

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Therabody Theragun Prime Review | Tom’s instructions

The best Theragun Prime offers for 4th generation percussive therapy massagers

Therabody Theragun Prime: specifications

PPM: 1,750 to 2,400
Amplitude: 16mm
Evaluated noise level: 65 decibels
Battery life: 2 hours
Weight: 2.9 pounds

Among the massage guns, the Therabody Theragun Prime has generated a lot of buzz thanks to Instagram influencers, online ads, and elsewhere. But does this expensive percussion massager live up to the hype?

The Theragun Prime is said to be 70 percent quieter than the previous versions and has five built-in speed ranges from 1,750 percussions per minute (PPM) to 2,400 PPM. The “percussion” part of the device lets the head “punch” the skin so that it feels more intense and hits the muscles more deeply than with a vibration massage therapy device that does not have this “drilling” effect with the massage head. The company says it goes 60 percent deeper into the muscle than your average massager.

As our Therabody Theragun Prime review shows, this is by no means an inexpensive massage gun, but the high-speed motor and technology could be useful for athletes who want to activate muscles to warm up or help with recovery efforts.

Theragun Prime Rating: Price and Availability

Theragun Prime is priced at $ 299 and can be purchased through their website or through Amazon. We like that they offer military personnel, veterans, first responders, and medical personnel a 20 percent discount through their website when you shop through the Therabody website. You can return for a refund within 30 days of purchase if you purchase through Therabody, and it should be available for free returns through Amazon if you purchase there too (but always read the fine print).

Theragun Prime Review: Establishment

The instructions in the kit suggest that you download the Therabody app and connect your device via bluetooth. You can use the device without the app or a smartphone and play around with the various attachments and grips, but there are no instructions in the package on how to use this properly and effectively, so downloading the free app is your best bet for the full Theragun -Adventure.

Theragun Prime Rating: Ergonomics

When the Theragun Prime arrived and I lifted it out of the box, my first thought was, “Oh, that’s a little hard.”

Therabody Theragun Prime Review

(Image credit: Therabody)

Although it weighs less than three pounds, it had weight; I wondered if it would feel difficult to stay in multiple positions. However, it is easy to turn on the device by holding down the power button and using the up and down arrows to adjust the speed.

Therabody Theragun Prime Review

(Image credit: Therabody)

The triangular shaped device has an ergonomic handle so that you can hold the device in different ways while wearing it on your body without tiring or straining your wrists, hands or arms. When I followed a routine on the app, often at the end of a 6 minute session, my arm and wrist would get a little tired holding them.

Theragun Prime Review: Achievement

“Whoa! That is intense! ”

I’ve used soft heating pads for back pain and some vibration massagers with rolling balls in the past, but the intensity of the Theragun Prime’s punch-punch-punch percussion device was unlike anything I’ve ever felt before.

When I first used the Prime, I found it difficult to properly hold the device on my shins and calves, and the high frequency pressure felt more intense in some of these areas. Later I got used to the different grips and feel of the damper and other mounting heads on my skin and muscles.

Therabody Theragun Prime Review

(Photo credit: Diana Kelly Levey / Toms Guide)

I found that using the Prime on my lower back, buttocks, and thighs felt good and more pain-relieving than smaller muscles like my forearms, hands, and even the neck area. I tried it as a “warm-up” a couple of bike rides, but didn’t notice any difference in my feeling during training. I used the Theragun Prime after biking and walking and found that while it felt good, it didn’t make much of a difference to my recovery.

Therabody Theragun Prime Review

(Photo credit: Diana Kelly Levey / Toms Guide)

I like that the app shows you the suggested grip for each part of the body you use it on. An inverted grip means you put your hand through the device, the base grip is when you put your thumb through the triangle and grab the front of the device, and the standard grip means you hold the device by the side of the triangle, where the power switch is located.

Theragun Prime Review: Appendices

The Prime contains four attachments, which are equipped with non-porous, closed-cell foam so that it can be cleaned easily. Each attachment has a unique shape designed to ensure the right treatment in the right area of ​​the body.

Therabody Theragun Prime Review

(Image credit: Therabody)

Most of the time I have used the standard damper attachment for my massage sessions as it is recommended in most guided routines and feels good on most parts of the body. The cone-shaped attachment is recommended for targeting feet and hands, the standard ball attachment is a firmer version of the damper and is well suited for small and large muscle groups such as the buttocks and calves. The thumb-shaped attachment actually relies on the founder’s thumb (Dr. Jason Wersland) to help with certain trigger points and lower back release.

Theragun Prime Review: Noise Levels

Theragun says the Prime is 70 percent quieter than previous versions thanks to its QX65 Motor Quietforce Technology. I wouldn’t describe the device as loud, but it’s certainly not “quieter than an electric toothbrush” as it says on the website – it’s more like a digital air compressor that we would plug into the car battery when filling up a tire.

When I first turned on the device, I was concerned that my sleeping toddler would hear it about 10 meters away and wake up, so I moved to another room (he never woke up to the sound).

There is a picture on the website of a couple in bed with the man carrying the Prime on his shoulder while his wife is sound asleep next to him; I cannot imagine a person lying in bed next to another person and the device not hearing.

Therabody Theragun Prime Review

(Image credit: Therabody)

While wearing the Theragun Prime around my neck and upper back, I couldn’t hear the TV show I was watching, but when I was using the device on the lower part of my body, the sound from the Prime didn’t interrupt my TV watching. My husband didn’t have to turn up the TV to hear the broadcast when I was using the device nearby.

Theragun Prime Review: The App

I found the Therabody app to be pretty impressive and easy to use. There are many guided sessions available to help you warm up before a particular workout or sport, recover after certain workouts and sports, relieve stress, sleep better, and relieve pain while sitting at the computer. You can also search for guided sessions on specific body parts. Searching for “back” displayed results from guided sessions for lower back, upper back, upper body recovery, sciatica, baseball warm up, baseball recovery, softball recovery, and softball warm up.

(Image credit: Therabody)

Therabody seems to be adding more and more guided sessions to the app – I couldn’t remember watching baseball, hiking, surfing, and kayaking when I first downloaded the app in late spring 2021. Most of the routines guided include a video from Dr. Wersland, how it’s done The device helps with certain parts of the body.

It was a challenge to achieve the optimal force range of pressure specified in the app. It often fluctuated between optimal and too high for me. You can adjust the pressure per minute at the bottom of the app to make the frequency slower.

You can “save” programs for quick return later, and even sync Therabody with health apps like the Apple Health and Strava apps to recommend routines for you based on your training and daily activities.

I liked the variety of routines and guided sessions with timed “steps” that showed you which attachment to use, where to place the device, how to hold the Prime, and the benefits of each routine. The “Work from Home” session says it is designed to get the blood flowing into your forearms, traps, lower back, and calves.

As soon as you switch on the device and click on “Start” in the app, the Prime will come to life and the power and frequency will automatically switch to the suggested standard setting “optimal”. Sometimes this default frequency setting felt a little too much for me, so I adjusted it in the app. For example, during the work from home session, you use the device on your forearm and apply it up and down. The default frequency is 2400 PPM, which can feel a bit intense at first, so I scaled the app down.

Theragun Prime in the test: battery life

The company says a fully charged Theragun Prime will last up to two hours. I used the massage gun a couple of times a week, about 5 to 7 minutes or so, and didn’t need to recharge it for about 45 days.

Theragun Prime: Judgment

The Theragun Prime was pretty impressive. If you are an athlete or if you train hard and exercise regularly, this is a great solution for rest or warm up and is much cheaper and more convenient than regular sports massages. It’s nice that the battery life seems long and it doesn’t have to be plugged in to use it. Therabody did a good job with the app which helped remove the intimidation factor about using this noisy, vibrating device.

At $ 299, the average consumer in pain would benefit more from a less expensive massage gun that does not penetrate as deeply. But for those who need something to get those muscles right, the Theragun Prime is worth it.

Therabody Theragun Prime Review | Tom’s instructions Read more on: https://www.americanchiropractors.org/

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Community News: Fitzgibbon Chiropractic Celebrates Five Years Anniversary (09/17/21)

September marks the fifth anniversary of the Fitzgibbon Chiropractic Clinic, which opened on September 6, 2016. Dr. During this time, Kylie Clemons has used chiropractic care to relieve pain and build relationships with local mothers-to-be, men, women and children from newborns. The Fitzgibbon Chiropractic Clinic is now located next to the Fitzgibbon Orthopedics and Sports Medicine on the second floor of the Fitzgibbon Hospital.

?? One of the reasons chiropractic treatment is built into Fitzgibbon Hospital is because insurance companies often want to perform less invasive treatments before approving surgery ?? said Clemons. ?? It is very convenient for our patients as they can immediately make an appointment with Fitzgibbon Orthopedic and Sports Medicine at the same desk if their injury needs medical care outside of my practice. ??

While there are other chiropractic clinics in the Marshall area, Dr. Clemons the only woman to offer chiropractic care. As a new mom herself, her understanding of the issues facing pregnant women helps care for many women referred by Marshall Women’s Care as well as other gynecological clinics in the area.

?? We care for women chiropractically up to birth, ?? said Clemons. Chiropractic in pregnancy has been shown to reduce labor times and help the baby move into a better position for eventual arrival.

Clemons also cares for newborn babies who may have chiropractic problems after birth. This can often lead to problems that affect the baby’s growth and development during its most formative period.

In addition to standard chiropractic care, Dr. Clemons is certified in chiropractic sports medicine, which enables her to specialize in the care of athletes on local high school and college sports teams. As part of these skills, she offers free physical exercise to students from the area’s school districts.

?? If I’ve been to a sporting event and need to stabilize an athlete’s spine after an injury, I am qualified for this care ,? said Clemons.

In 2018, Fitzgibbon Hospital added MLS laser therapy to the offer of Dr. Clemons added to her clinic. This ?? deep heat ?? The therapy alleviates the pain of a number of conditions that cause loss of mobility and productivity in people in pain, as well as in athletes who may have sustained a sports injury. Each treatment takes between three minutes and 10 minutes, depending on the size of the area to be treated.

?? This deep heat therapy works for conditions like bursitis, arthritis, plantar fasciitis in the soles of the feet, sprains and strains. It’s always nice to see someone start moving their fingers again after MLS laser therapy treatment, for example after having arthritis in their hands ?? said Dr. Clemons. ?? University athletes receive a discount on the MLS laser therapy service. However, high school athletes typically don’t get MLS because we are unable to treat over a growth plate.

If you are in need of chiropractic care, MLS laser therapy, or are an athlete in a local school district in need of an exercise exam, Dr. Clemons new patient. Call 660-831-3743 to make an appointment.

The following article Community News: Fitzgibbon Chiropractic Celebrates Five Years Anniversary (09/17/21) was published to AmericanChiropractors

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Efficacy and Safety of Cryoneurolysis for Treatment of Chronic Head Pa

Plain Language Summary

Occipital neuralgia (ON) is a medical condition that may cause serious, stabbing headache. Healthcare providers use a variety of treatments for ON, but there remains a need for a long-lasting therapy for ON that also does not require a major surgical procedure.

In a clinical trial with twenty-six patients, we studied the effect of a medical procedure called cryoneurolysis. This procedure works by freezing a specific nerve, which may help improve pain. We studied if cryoneurolysis can improve pain due to ON a week after receiving treatment. We also examined if this procedure had any side effects.

Sixteen out of twenty-five patients (64%) had less pain a week after treatment, and similar results were also observed after a month. Nine out of twenty-six patients (35%) continued to see a positive effect from the therapy approximately two months from the treatment. No serious side effects were reported. Approximately two months from the treatment, twenty-one of twenty-six patients (81%) said they would recommend the treatment to a family member and eighteen of twenty-six patients (69%) said they would be willing to have the treatment again.

In summary, we have observed that cryoneurolysis can provide meaningful pain relief in patients with ON for up to a month, and cryoneurolysis appears to be safe.

Introduction

Occipital neuralgia (ON) is a cause of headache that originates at the base of the head and spreads to the back, front, or side of the head, including the area behind the eyes.1,2 ON can be unilateral or bilateral and is characterized by paroxysmal severe pain that is shooting, stabbing, or sharp in quality in the distribution of the greater or lesser occipital nerves.1 The etiology of ON may be idiopathic or structural and can vary from patient to patient.3 For many patients, the etiology is unknown, but some events associated with the development of ON include irritation, inflammation, compression, or injury of the occipital nerves.3,4

According to the International Headache Society diagnostic criteria for ON, diagnosis can be confirmed on the basis of clinical presentation of pain (ie, episodic stabbing pain and tenderness over the affected nerve) and a temporary improvement in pain with local anesthetic block of the nerve.1,4 However, occipital nerve block is not a specific diagnostic criterion for ON, and false-positive results can occur with cases of migraines and cluster headaches.4 In addition, patients with ON may experience symptoms similar to migraine or cluster headaches, such as photophobia, phonophobia, dizziness, nausea and vomiting, and posterior scalp paresthesia, further complicating diagnosis.2,3 ON is often misdiagnosed as migraine, fibromyalgia, cervical spine arthritis, cervical disc disease, and cervicogenic headache.3,5

In addition to diagnostic difficulty, management of ON can be complex, and there is currently no consensus treatment for ON.4 Management of ON typically starts with physical measures such as posture correction, anti-inflammatory medications, medications effective for neuropathic pain (eg, anticonvulsants, antidepressants), and opioids. Additional therapeutic approaches include botulinum toxin, local nerve blocks and corticosteroid injections, radiofrequency ablation, and neurostimulation. In difficult-to-treat cases with presumed nerve entrapment, surgical decompression is considered.3,4 Each strategy offers varying relief of symptoms, duration of action, and invasiveness. However, there remains a need for novel nonsurgical, minimally invasive, and long-lasting approaches to ON pain management.6

Cryoneurolysis is a form of thermal neurolysis involving the application of cold temperature to peripheral sensory nerves to achieve a long-lasting nerve block. When nitrous oxide is used, cryoneurolysis occurs at temperatures of −20°C to −100°C.7 In this temperature range, the affected nerve will undergo Wallerian degeneration, in which the nerve axon is targeted but the nerve sheath is preserved, allowing for axonal regeneration.7–9 Advantages of cryoneurolysis over neurolytic modalities such as chemical neurolysis and radiofrequency ablation include less damage to tissue architecture and adjacent tissues and a reduced risk of neuroma.9–11 Although cryoneurolysis has been previously investigated for cervicogenic headache,12 studies evaluating the potential benefit and safety of cryoneurolysis for treatment of chronic head pain secondary to ON are needed.

The investigated cryoneurolysis device in the current study was precursor to a class 2 medical device cleared by the US Food and Drug Administration (Pacira Cryotech, Fremont, CA).13 Both devices deliver liquid nitrous oxide within a closed-end probe to apply freezing temperatures as low as −88°C to target nerves, resulting in reversible Wallerian degeneration.7 In addition, both systems include an integrated skin warmer, which may protect the skin and hair in the treatment area from subdermal or follicular necrosis.7 Previous results from a multicenter, randomized, double-blind, sham-controlled study demonstrated that cryoneurolysis via the newer-generation device was a safe and effective approach to treating pain and symptoms associated with osteoarthritis of the knee.14 Other studies have suggested that cryoneurolysis via the newer-generation device prior to total knee arthroplasty can reduce knee symptoms, shorten length of hospital stay, and reduce opioid consumption compared with standard of care.15,16

Use of cryoneurolysis or cryoablation (which uses colder temperatures than cryoneurolysis) to treat unilateral or bilateral occipital neuralgia with other devices has been described previously.2,17,18 However, additional safety and efficacy data are required to validate the approach more using the moderate temperature range produced by nitrous oxide, which enables nerve regeneration. This was a proof-of-concept pilot study designed to provide initial evaluation of the efficacy, safety, and duration of clinical effect with cryoneurolysis in patients with ON, which may help inform the direction of future controlled studies.

Patients and Methods

Study Design and Population

This was a prospective, multicenter, single-arm, pilot study to assess the safety and effectiveness of cryoneurolysis for pain due to ON (NCT01753765). Patients were treated between November 2012 and December 2013. Individuals were eligible for inclusion in the study if they were aged ≥18 years, had a confirmed diagnosis of unilateral or bilateral ON, had a mean numeric rating scale (NRS) pain score of ≥4 during the 7 days leading up to the study, and were not pregnant at the time of treatment; patients on medication before starting treatment were required to maintain a stable medication schedule, as determined by the physician, prior to treatment. Individuals were excluded if they had a current diagnosis of fibromyalgia, chronic back pain, or chronic migraines; history of cerebrovascular accident, head trauma, stroke, or bone deformity; severe pain for any reason other than ON; any clotting disorder and/or use of anticoagulant within 7 days prior to start of treatment; injections for pain relief or neuromodulation to the upper trunk or head within 3 months prior to start of treatment; anesthetics or steroids within 30 days prior to start of treatment; or previous surgery in intended area of treatment.

Procedures and Treatments

The treatment target was the greater occipital nerve (Figure 1). Because the anatomical landmark technique used for identifying the treatment area could not reliably differentiate the greater occipital nerve from the lesser occipital or the third occipital nerves, any of these nerves may have been targeted by treatment. The nerves were accessed by locating adjacent landmarks with ultrasound and/or percutaneous nerve stimulation. Local cutaneous anesthesia was administered via subdermal injection of local anesthetic. Treatment was performed by inserting the cryoprobe in a linear fashion, with subsequent treatments to block the nerve path at the location identified by the investigator. Each treatment cycle consisted of a 15-second pre-warming cycle, a 60-second treatment delivery, and a 10-second warming period after treatment. After the treatment cycle was completed, the cryoprobe was removed and reinserted to form a treatment line intersecting the predicted nerve path. Patients with a bilateral indication could receive treatment unilaterally or bilaterally at the discretion of the investigator.

Figure 1 Nerve map of intended treatment area, including greater occipital nerve and lesser occipital nerve (A), and anatomical dissections of the treatment area (B).

End Points and Assessments

The primary outcome measure of the study was improvement from baseline in pain due to ON at day 7 as measured on an 11-point (scale of 0 to 10) NRS for pain, where 0 represents no pain and 10 represents very severe pain. Pain NRS scores were also assessed before treatment, immediately post treatment, and at 30 days post treatment.

Secondary endpoints included duration of treatment effects and safety, including adverse events (AEs). Duration of treatment effect was assessed at days 7, 30, and 56 by asking if patients were continuing to experience a treatment effect; potential responses included “effect,” “no effect,” or “no longer effective.” Patients who reported a treatment effect at day 56 were monitored via phone follow-up at 4-week intervals up to day 112 for as long as they were experiencing a treatment effect. This assessment was also completed via phone at days 84 and 112, and at 4-week intervals thereafter.

On the basis of known risks associated with cryoneurolysis devices, several treatment-related AEs (TRAEs) were defined a priori and reported. Predefined TRAEs were bruising, tingling, erythema, swelling, itching, local pain/tenderness, erosion/ulceration, crusting, dimpling, hyperpigmentation, and hypopigmentation. These anticipated TRAEs do not typically require medical intervention and are transient in duration. Any AE that exceeded the expected response to treatment in severity or in duration was separately reported. To assess safety, the treatment area was examined during each visit for TRAEs. All AEs were reported. AEs, serious AEs (SAEs), and unanticipated adverse device effects (UADEs) were also assessed at all visits.

To assess patient satisfaction, a posttreatment questionnaire was administered that included 4 yes/no questions: one question regarding whether the patient would recommend the treatment to a family member, one regarding whether the patient would take the treatment again, one regarding the occurrence of anticipated observations (ie, safety signals), and one regarding pain from study treatment. If the patient answered “yes” to the occurrence of anticipated observations and/or pain, he or she was asked to report the impact of anticipated observations on their daily routine and/or determine the severity of pain from study treatment on a scale of 1 to 5.

This postmarketing study was approved by an Institutional Review Board (IntegReview Ethical Review Board, now Advarra, Columbia, MD, USA) and was conducted in accordance with the general principles set forth in the International Council for Harmonisation Guidelines for Good Clinical Practice and the Declaration of Helsinki. All patients provided written informed consent before enrollment in the study.

Statistical Analysis

NRS pain scores were analyzed for response rates, clinically important differences, and statistically significant improvements from baseline (ie, preprocedure day 0) at each follow-up visit. NRS pain score changes from baseline were calculated by subtracting the score at post-treatment, Day 7, and Day 30 from the NRS pain score reported at baseline, and these differences were analyzed for statistical significance using a null hypothesis (ie, difference from baseline of 0). A paired, two-tailed t-test was used to account for the possibility of patients worsening over the course of the study and had a significance level of P<0.05. Duration of treatment effect was analyzed for the number of responders at each follow-up point.

Results

Patient Disposition and Baseline Demographics

Overall, 26 patients were enrolled in the study, including 17 patients who received bilateral treatment and 9 patients who received unilateral treatment, for a total of 43 treatment areas. All patients completed the study and were included in the final analysis. The majority of the patients (n=17; 65%) in the study were female, with a mean (standard deviation [SD]) age of 49.1 (13.0) years and mean (SD) baseline NRS pain score of 6.3 (1.5).

Efficacy

NRS Pain Scores

NRS pain scores decreased immediately after treatment and remained lower than baseline scores through at least day 30 (Supplemental Figure). For the primary outcome measure, 84% of patients (21/25) reported a ≥1 point improvement in NRS pain scores at day 7. When NRS pain scores were assessed immediately post treatment and at day 30, 92% (24/26) and 78% (18/23) of patients reported a ≥1 point improvement, respectively. A clinically important improvement in NRS pain scores has been previously defined as an improvement of 1.3 on a scale of 0 to 10.19 Because this study only included NRS responses on a whole-number scale, an improvement of ≥2 points was considered clinically meaningful, which was experienced by 88% (23/26), 64% (16/25), and 74% (17/23) of patients immediately post treatment, at day 7, and at day 30, respectively. Moreover, mean (SD) NRS improvements of 2.8 (2.1), 3.8 (2.3), and 3.6 (2.4) exceeded the clinically important threshold immediately posttreatment, at day 7, and at day 30, respectively (Table 1).

Table 1 Mean Improvement in NRS from Baseline

Duration of Treatment Effect

The proportion of patients reporting a treatment effect at each follow-up was calculated both as a proportion of the total study population and as a proportion of the patients with data at each respective follow-up visit (Table 2). At day 30, 50% of patients (13/26) reported a continued effect from treatment, and at day 56, 35% (9/26) reported a continued effect. Treatment effects were reported at up to 112 days after cryoneurolysis in some patients.

Table 2 Patients Reporting Continued Treatment Effect Over Initial Follow-Up Period

Patient Experience

The responses to the questionnaire on patient satisfaction are shown in Table 3. At day 7, 69% of patients (18/26) indicated that they would recommend the treatment to a family member; this number increased to 81% (21/26) at day 56. When asked whether they would be willing to have the treatment again, 69% of patients (18/26) responded “yes” at days 7 and 56.

Table 3 Patient Satisfaction

A total of 54% (14/26), 4% (1/23), and 0 patients reported treatment-related pain on days 7, 30, and 56, respectively. Patients who reported pain were asked to rate the pain on a scale of 1 to 5 (1 = not at all painful, 5 = very painful); only one patient at day 7 reported treatment-related pain as a 4, and all other pain scores were ≤3.

Safety

Anticipated Treatment-Related Adverse Events

At day 7, 77% (20/26) of patients reported anticipated TRAEs, but this proportion decreased at subsequent follow-up visits (Table 4). Most patients who reported any anticipated TRAEs indicated these events had little to no impact on their daily routine.

Table 4 Patient-Reported Anticipated TRAEs

Anticipated TRAEs were assessed per treatment area across all patients (Table 5). No severe anticipated TRAEs were reported in the study. The most frequently reported anticipated TRAE was crusting at the insertion site. Crusting was reported as mild in 23/43 (53%) treatment areas and moderate in 4/43 (9%) treatment areas at day 7; all crusting resolved before the assessment on day 30. Redness/inflammation, local pain, swelling, itching, and hyperpigmentation were all reported in over 20% of the study population at day 7. Twelve percent of patients reported mild tingling at day 7, and all cases of tingling resolved by day 30; however, 2 additional reports of tingling were reported at day 56 in 2 patients who had not previously reported any tingling. Anticipated TRAEs were less prevalent beyond day 7; redness/inflammation, local pain, itching, hyperpigmentation, and tingling were reported in <10% of patients on days 30 and 56. No new cryoneurolysis treatment risks were documented in the study population.

Table 5 Reported Anticipated TRAEs by Treatment Areaa

A total of 6 AEs reported by 5 patients (19%) were unanticipated in either type, severity, or duration, of which 2 AEs (pain in treatment area and increased pain in neck area) were considered possibly treatment related. Both events were considered moderate in severity and did not require an intervention. No serious AEs, discontinuations due to AE, or unanticipated adverse device effects were reported during the study.

Discussion

Cryoneurolysis provided rapid and meaningful relief from pain associated with ON. A total of 88% of patients experienced clinically important improvement in pain scores (≥2 points) on the day of the treatment. The NRS scores also significantly improved from baseline by mean 3.5 points on the day of treatment, representing an average of a 55% improvement in pain scores from baseline. Significant reductions in pain scores were consistently observed through day 30, and the mean reduction in NRS score exceeded the clinically important improvement threshold at day 30. The effects of cryoneurolysis lasted up to 8 weeks in 35% of patients.

Diagnostic challenges due to resemblance of ON manifestations to other disorders20 and lack of consensus guidelines make managing ON difficult. Over-the-counter pain medications have short-term effects on pain associated with ON and may have increased risks with long-term use.4,21 Occipital nerve blocks using local anesthetics with or without steroids can produce short-term relief of symptoms, but their limited duration of action may restrict their use as long-term management.4 Although botulinum toxin has had success in management of migraines,22 use of botulinum toxin to manage pain associated with ON has not been consistently helpful.4 Pulsed radiofrequency treatment has demonstrated short- to intermediate-term pain control for patients with ON,4 but important prospective evidence on the effectiveness of pulsed radiofrequency treatment is lacking. More recently, neurostimulation has been shown to provide symptom relief in patients with ON, but it requires an implanted electrode and, in most cases, an implanted pulse generator for long-term use.4,23 Use of cryoneurolysis within the moderate temperature range produced by nitrous oxide to manage pain associated with ON could provide a minimally invasive, effective, and safe alternative for these patients. Overall, this pilot study found cryoneurolysis therapy to be safe and tolerable, with no reported serious AEs, device-related serious AEs, or new cryoneurolysis-related risks to patients.

The favorable safety profile of cryoneurolysis may enable repeated treatments for chronic pain without increasing risks for patients; however, utility of repeated treatment requires further study. Cryoneurolysis is not expected to have a permanent effect on pain, as the −88°C temperature achieved by the probe investigated here causes degeneration of the axon yet preserves the nerve sheath, allowing the targeted nerve to regenerate and regain function.7 Multiple cryoneurolysis treatments with the device investigated in this study have demonstrated nerve regeneration that is consistent and predictable,9 extending the potential clinical benefits of this therapy. However, while the NRS pain scores reported in this study were significantly reduced compared with baseline scores (P < 0.0001), pain was not completely abolished (ie, NRS pain scores did not reach 0). The significance of this result is beyond the scope of the current study, and future studies may help determine the optimal approach for management of ON-associated pain.

There were several limitations to this study. The main limitation of this study was its uncontrolled, unblinded design, which precludes a comparison of the investigated treatment with other ON treatments. Although this was a prospective study, the lack of a control group likens this pilot study to a case series and introduces potential for bias. Thus, the efficacy reported in this report should be interpreted carefully. In addition, the small population size included in this study limits the generalizability of these findings. Finally, this study did not include outcome measures to assess the impact of cryoneurolysis on participants’ quality of life (eg, PQRST, QISS TAPED). However, these limitations do not preclude the utility of this preliminary study in informing future, more rigorous, clinical trials. While any conclusions drawn from this pilot study must be limited, the results provide foundational knowledge on the degree and duration of cryoneurolysis effect to support larger, controlled studies of this treatment in patients with ON. Future clinical studies of cryoneurolysis for treatment of chronic head pain secondary to ON should include a comparator group (eg, placebo or sham procedure, or active control of another ON treatment); a randomized design; more thorough characterization of the participant population at baseline, including the duration of chronic pain associated with ON; and comparisons of both NRS pain scores and quality-of-life measures (eg, PQRST, QISS TAPED) between treatment groups.

In the majority of patients in this study, cryoneurolysis therapy provided fast-acting and durable pain management due to ON, and no serious AEs were reported. The efficacy and safety observed in this pilot study support further investigation of cryoneurolysis for relief of chronic pain associated with ON.

Data Sharing Statement

The data sets used and/or analyzed during the current study are available from the corresponding author upon reasonable request.

Acknowledgments

This study was supported by Pacira BioSciences, Inc. Writing and editorial assistance were provided under the direction of the authors by Elizabeth Harvie, PhD, CMPP, ELS, and Emilia Raszkiewicz of MedThink SciCom with support from Pacira BioSciences, Inc.

Author Contributions

All listed authors meet the criteria for authorship set forth by the International Committee of Medical Journal Editors, ie, they made a significant contribution to the work reported. All authors made substantial contributions to conception and design, acquisition of data, or analysis and interpretation of data; took part in drafting the article or revising it critically for important intellectual content; agreed to submit to the current journal; gave final approval of the version to be published; and agree to be accountable for all aspects of the work.

Funding

This study was sponsored by Myoscience Inc., including study design and funding. Myoscience Inc. was acquired by Pacira BioSciences, Inc. after completion of the study. Pacira BioSciences, Inc. was involved in the analysis and interpretation of the data. Writing and editorial assistance were also supported by Pacira BioSciences, Inc.

Disclosure

Dr Richard Radnovich reports grants from Myoscience, during the conduct of the study. The authors report no other conflicts of interest in this work.

References

1. Headache Classification Committee of the International Headache Society (IHS). The International Classification of Headache Disorders, 3rd edition. Cephalalgia. 2018;38(1):1–211. doi:10.1177/0333102417738202

2. Stogicza A, Trescot A, Rabago D. New technique for cryoneuroablation of the proximal greater occipital nerve. Pain Pract. 2019;19(6):594–601. doi:10.1111/papr.12779

3. Barna S, Hashimi M. Occipital neuralgia. Pain Manag Rounds. 2004;1(7):1–5.

4. Choi I, Jeon SR. Neuralgias of the head: occipital neuralgia. J Korean Med Sci. 2016;31(4):479–488. doi:10.3346/jkms.2016.31.4.479

5. Yi X, Cook AJ, Hamill-Ruth RJ, Rowlingson JC. Cervicogenic headache in patients with presumed migraine: missed diagnosis or misdiagnosis? J Pain. 2005;6(10):700–703. doi:10.1016/j.jpain.2005.04.005

6. Urits I, Schwartz RH, Patel P, et al. A review of the recent findings in minimally invasive treatment options for the management of occipital neuralgia. Neurol Ther. 2020;9(2):229–241. doi:10.1007/s40120-020-00197-1

7. Ilfeld BM, Preciado J, Trescot AM. Novel cryoneurolysis device for the treatment of sensory and motor peripheral nerves. Expert Rev Med Devices. 2016;13(8):713–725. doi:10.1080/17434440.2016.1204229

8. Evans PJ. Cryoanalgesia. The application of low temperatures to nerves to produce anaesthesia or analgesia. Anaesthesia. 1981;36(11):1003–1013. doi:10.1111/j.1365-2044.1981.tb08673.x

9. Hsu M, Stevenson FF. Wallerian degeneration and recovery of motor nerves after multiple focused cold therapies. Muscle Nerve. 2015;51(2):268–275. doi:10.1002/mus.24306

10. Choi EJ, Choi YM, Jang EJ, Kim JY, Kim TK, Kim KH. Neural ablation and regeneration in pain practice. Korean J Pain. 2016;29(1):3–11. doi:10.3344/kjp.2016.29.1.3

11. Brace C. Thermal tumor ablation in clinical use. IEEE Pulse. 2011;2(5):28–38. doi:10.1109/MPUL.2011.942603

12. Kvarstein G, Högström H, Allen SM, Rosland JH. Cryoneurolysis for cervicogenic headache – a double blinded randomized controlled study. Scand J Pain. 2019;20(1):39–50. doi:10.1515/sjpain-2019-0086

13. Myoscience Inc. Iovera° User Guide. Fremont, Ca: Myoscience, Inc.; 2018.

14. Radnovich R, Scott D, Patel AT, et al. Cryoneurolysis to treat the pain and symptoms of knee osteoarthritis: a multicenter, randomized, double-blind, sham-controlled trial. Osteoarthritis Cartilage. 2017;25(8):1247–1256. doi:10.1016/j.joca.2017.03.006

15. Dasa V, Lensing G, Parsons M, Harris J, Volaufova J, Bliss R. Percutaneous freezing of sensory nerves prior to total knee arthroplasty. Knee. 2016;23(3):523–528. doi:10.1016/j.knee.2016.01.011

16. Mihalko WM, Kerkhof A, Ford MC, Crockarell JR Jr, Harkess JW, Guyton JL. Cryoneurolysis before total knee arthroplasty in patients with severe osteoarthritis for reduction of postoperative pain and opioid use in a single-center randomized controlled trial. J Arthroplasty. 2020;36(5):1590–1598. doi:10.1016/j.arth.2020.11.013

17. Kim CH, Hu W, Gao J, Dragan K, Whealton T, Julian C. Cryoablation for the treatment of occipital neuralgia. Pain Physician. 2015;18(3):E363–368. doi:10.36076/ppj.2015/18/E363

18. Kastler A, Attyé A, Maindet C, et al. Greater occipital nerve cryoneurolysis in the management of intractable occipital neuralgia. J Neuroradiol. 2018;45(6):386–390. doi:10.1016/j.neurad.2017.11.002

19. Bijur PE, Latimer CT, Gallagher EJ. Validation of a verbally administered numerical rating scale of acute pain for use in the emergency department. Acad Emerg Med. 2003;10(4):390–392. doi:10.1111/j.1553-2712.2003.tb01355.x

20. Hoppenfeld JD. Cervical facet arthropathy and occipital neuralgia: headache culprits. Curr Pain Headache Rep. 2010;14(6):418–423. doi:10.1007/s11916-010-0151-5

21. Ho KY, Gwee KA, Cheng YK, Yoon KH, Hee HT, Omar AR. Nonsteroidal anti-inflammatory drugs in chronic pain: implications of new data for clinical practice. J Pain Res. 2018;11:1937–1948. doi:10.2147/JPR.S168188

22. Jackson JL, Kuriyama A, Hayashino Y. Botulinum toxin A for prophylactic treatment of migraine and tension headaches in adults: a meta-analysis. JAMA. 2012;307(16):1736–1745. doi:10.1001/jama.2012.505

23. Slavin KV, Nersesyan H, Wess C. Peripheral neurostimulation for treatment of intractable occipital neuralgia. Neurosurgery. 2006;58(1):112–119. doi:10.1227/01.neu.0000192163.55428.62

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EzFill announces the completion of the IPO and the full exercise of the over-allotment option

MIAMI, FL, September 17, 2021 (GLOBE NEWSWIRE) – EzFill stocks, Inc. (“EzFill” or the “Company”), (NASDAQ: EZFL) an emerging leader in the fast-growing on-demand mobile fuels industry, today announced the completion of its initial public offering of 7,187,500 common shares at a public offering price of $ 4.00 per share, including 937,500 shares that will be sold upon full exercise of the syndicate agreement Options to buy additional shares were sold. The gross proceeds of the offering, including the over-allotment option shares, were $ 28,750,000, net of subscription discounts, commissions and offering costs.

The common stock trades on the Nasdaq Capital Market under the ticker symbol “EZFL”.

The company plans to use the net proceeds from the offering to gain additional market share in Florida, where it is currently the largest on-demand mobile fuel provider, as well as for national expansion, technology development, debt restructuring, and other general corporate and working capital costs .

ThinkEquity acted as the sole book-running manager for the offering.

The registration statement on Form S-1 (File Number 333-256691) in relation to the shares sold under this offering has been filed with the Securities and Exchange Commission and has become effective on September 14, 2021. The proposed offer was filed and made available on the SEC’s website at https://www.sec.gov/. The offer is made exclusively by means of a prospectus. Electronic copies of the final prospectus are available from ThinkEquity, 17 State Street, 22nd Floor, New York, New York 10004, by phone at (877) 436-3673 and by email at prospekt@think-equity.com.

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor will any sale of these securities be made in any state or jurisdiction in which such offer, solicitation or sale prior to registration would or would be unlawful or unlawful Qualification under the securities laws of such state or jurisdiction.

The story goes on

About EzFill

EzFill is a leading player in the fast growing mobile fuel industry with the largest market share in its home state of Florida. Its mission is to revolutionize the gas station model by bringing consumers and businesses the convenience, safety and touchless benefits of on-demand gas stations delivered right to their locations. For commercial and special customers, on-site delivery during downtime enables operators to start their day-to-day operations with fully fueled vehicles. Please visit https://getyourezfill.com for more information.

Forward-Looking Statements

This press release contains “forward-looking statements.” Forward-looking statements reflect our current assessment of future events. In this press release, the words “anticipate”, “believe”, “estimate”, “expect”, “future”, “intend”, “plan” or to us or our management will identify forward-looking statements. These statements include, but are not limited to, statements in this press release relating to our business strategy, future operating results, and the outlook for liquidity and capital. Forward-looking statements are based on our current expectations and assumptions about our business, the economy and other future conditions. Because forward-looking statements address the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict. Our actual results could differ materially from those anticipated in the forward-looking statements. They are neither statements of historical facts nor guarantees of future performance. We therefore caution you not to rely on these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include our ability to raise capital to finance ongoing business operations; our ability to protect our intellectual property rights; the effects of infringement proceedings or other legal disputes brought against us; Competition from other providers and products; our ability to develop and market products and services; Changes in government regulation; our ability to complete fundraising transactions; and other factors relating to our industry, operations and results of operations. Actual results could differ materially from those expected, assumed, estimated, expected, intended or planned.

Factors or events that could cause our actual results to differ could occur from time to time and we cannot predict them all. We cannot guarantee future results, activity levels, accomplishments or successes. The company assumes no obligation to update any forward-looking statements to reflect events or circumstances that may arise after the date of this publication

For more information please contact:

Investor and media contact
KCSA Strategic Communication
Kathleen Heaney / Joshua Greenwald
EzFill@kcsa.com

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MitoBurn from NNB Nutrition is now self-certified GRAS

MitoBurn (β-aminoisobutyric acid or L-Baiba) from NNB Nutrition, a non-protein amino acid metabolite of the branched chain amino acid L-valine, is now self-confirmed GRAS (generally recognized as safe) as a powdered food ingredient in sports drinks and in grain-based bars, Nutritional bars and instant powdered nutritional beverages.

L-Baiba is produced both in the body and naturally in plants such as Theobroma cacao and Fabaceae. In humans, it is produced by skeletal muscles during exercise and plays a role in the benefits of regular exercise, including healthy glucose intake, increased free fatty acid oxidation, reduced fat mass, and mitochondrial health. According to Shawn Wells, CSO of NNB Nutrition, L-Baiba has also been linked to white adipose tissue tanning, where the oxidation of fatty acids enables more fat to be converted into ketones for use as fuel for exercise.

“With our GRAS certification, we believe this powerful, innovative ingredient will be a huge success in the nutritional supplement industry,” said Kylin Liao, founder of NNB Nutrition, in a press release.

MitoBurn from NNB Nutrition is now self-certified GRAS was seen on AmericanChiropractors

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Osteopathie boomt in der Corona-Krise

“Seit Beginn der Corona-Krise gibt es in Luxemburg einen Anstieg der osteopathischen Behandlungen”, sagte ein Sprecher des Luxemburger Osteopathenverbandes (Aldo) gegenüber L’essentiel. Im Homeoffice verbringen viele Menschen viel Zeit im Sitzen und nehmen oft eine schlechte Körperhaltung ein. Dies führt unter anderem zu Rückenschmerzen, Ischias und Kopfschmerzen und kann auch psychosomatische Erkrankungen auslösen. „Die Nutzung eines Laptops statt eines fest installierten Bildschirms verursacht zum Beispiel Nacken- und Rückenschmerzen“, sagt Aldo.



Schlechte Homeoffice-Bedingungen machen viele krank


Wie viele Osteopathen gibt es in Luxemburg?

Die “Association Luxembourgeoise des Ostéopathes” (Aldo) vertritt die Interessen von insgesamt 80 ausgebildeten Osteopathen, die im Großherzogtum praktizieren (mit Masterabschluss oder Osteopathiediplom).

Allerdings haben rund 150 Osteopathen die Zulassung vom Gesundheitsministerium erhalten – darunter auch Physiotherapeuten, die osteopathische Behandlungen anbieten. Derzeit erstattet die Luxemburger Krankenversicherungskasse (CNS) keine Kosten für osteopathische Behandlungen.

Die Osteopathin Laeticia Canale-Marianacci aus Belvaux konnte keinen Anstieg ihrer Patientenzahlen feststellen, da ihre Praxis bereits gut besucht war. “Der potenzielle Anstieg wurde jedoch dadurch ausgeglichen, dass einige Patienten aus Angst vor einer Ansteckung mit dem Coronavirus nicht mehr zur Behandlung kommen”, sagt sie. Sie stellte jedoch fest, dass sich einige Patienten darüber beschweren, dass sie sich jetzt ihre Jobs teilen müssen. Daher ist es nicht unbedingt an sie angepasst.

“Mehr Pathologien durch Telearbeit”

In der Arbeit von Canale-Marianacci geht es nicht nur darum, Verspannungen abzubauen, sondern auch um die Haltung von Patienten zu beraten. Ihre Botschaft ist klar: „Bewegung hält die Gelenke gesund. Gegen den Bewegungsmangel sollte man jeden Tag spazieren gehen – auch im Alter“, betont sie.

Dieselben Beobachtungen gelten für den Osteopathen Franck Bombardier, der seine Praxis in der Therme in Mondorf hat. „Seit Beginn der Corona-Krise beschäftigen wir uns hauptsächlich mit Pathologien, die mit der Telearbeit verbunden sind“, sagt er. Auch hier sind die Beschwerden auf die gleichen Ursachen zurückzuführen: Bewegungsmangel und ein ungeeigneter Arbeitsplatz. „Außerdem bemerke ich eine deutliche Verschlechterung der körperlichen Verfassung meiner Patienten, die darauf zurückzuführen ist, dass sie den Sport komplett eingestellt haben. Das wiederum verursacht Gelenk- und Muskelschmerzen“, sagt Bombardier.

Er setzt sich für die Einhaltung der Gesundheitsmaßnahmen ein und fordert alle auf, sich impfen zu lassen. Außerdem rät der Osteopath, sich täglich zu bewegen – auch wenn es sich nur um „moderate“ Bewegungen handelt. Wichtig sei auch „regelmäßiges Dehnen zu Hause“ und vor allem „Spaß dabei zu haben, seinem Körper etwas Gutes zu tun“, sagt Bombardier.

(pp / Das Wesentliche)

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Treatment of Military Populations

A most pronounced characteristic of the cases seen early in their illness is the profusion with which new symptoms appear and disappear. As time goes on, without treatment, a more stabilized syndrome crystallizes.1

Grinker RR; and Spiegel, JP. Men Under Stress(1945).

Those who have worked with combat veterans know that they are a group of patients who require a special degree of honesty and compassion. According to the US Census Bureau, there are 18.0 million veterans living in the United States, 17% of whom are women.2 In addition, at any given day, 1.4 million men and women serve on active duty, along with 718,000 civilian personnel. Another 1.1 million Americans serve in the National Guard and Reserve forces. It is estimated that 7% of the US population has military experience, which is a notable decrease from 18% in 1980. Among post-9/11 veterans, 43% have a service-connected disability,2 perhaps related to the fact so few in modern society (less than 1%) serve in the all-volunteer military, requiring citizen-soldiers and their families to carry the burden.

Unfortunately, institutions charged with caring for veterans are often unhelpful. The Veteran’s Administration’s (VA) lack of transparency is a significant handicap for veterans and family members seeking treatment and explanations for their mental illnesses. Researchers, clinicians, and journalists are unable to find answers to important questions about the impact of war on veterans and their families. How many post-9/11 veterans have been diagnosed and/or treated for posttraumatic stress disorder (PTSD)? How many veterans have been diagnosed with any other mental health-related condition?

It is hard to say. The VA’s annual reports on Analysis of VA Health Care Utilization Among Operation Enduring Freedom (OEF), Operational Iraqi Freedom (OIF), and Operation New Dan (OND) Veterans, stopped being publicly available in 2016. Nevertheless, based on 2015 data, we can say that over a million post-9/11 veterans are using VA healthcare, and mental disorders are prevalent in this population (Table 1).3 Aside from the fact the data are outdated, the data also captures only those veterans going to the VA. The VA does not keep track of those seeking counseling from the 360 veteran centers across the country3; nor those who seek help through the private sector; nor the largest subset of veterans and military personnel who suffer silently. Of course, there are multiple millions of family members and caregivers within the military population, those critical for the military veteran, are not covered for any services.

Differences in the Treatment of Military Versus Non-Military Populations

After publication of our book, Psychiatric Casualties: How and Why the Military Ignores the Full Cost of War,4 we were asked to opine on what clinicians should know about treating military populations (read an introduction to Dr Russell and Dr Figley’s book here – Ed.). First and foremost, while it is true that war changes everyone, it is also a great disservice to assume that most or all citizen-soldiers who served in the military and/or deployed to war zones, are fatally damaged goods. Going to war often signifies both the best and worst of times for veterans. Military populations offer fertile ground for studies on resilience and posttraumatic growth (PTG) among specialties within the service branches.

On the flip side, it is important not to view evidence of resilience or PTG as indicating an absence of mental or physical health-related problems. Another potential mistake is to assume that current or former military personnel must have suffered war trauma, and that is the primary or sole issue that leads them to seek mental health services. In reality, the all-voluntary military faces a wide-range of potential traumatic stressors that are inherent occupational hazards including combat, training accidents, transportation accidents, terrorist attacks, military sexual trauma, victims of crime, natural disasters, humanitarian relief missions, peace-keeping missions, along with other common stressors in the civilian sector (ie, domestic violence, childhood abuse, motor vehicle accidents, betrayal trauma, racial trauma, etc). The wise clinician is alert to the fact that even if a service member is a combat veteran, their distress will likely be a combination of factors, not just a product of combat experiences.

Next, clinicians should be sensitive to a host of risk factors and trauma-related conditions that are not entirely unique to military populations. Like police, federal and state law enforcement, and related professions, combat veterans, may deal with 1) the psychological impact of killing or seeing others killed; 2) having been wounded-in-the line of duty; 3) exposure to the presence of traumatic grief and complicated bereavement of fellow officers or from the death of a loved one, including one’s combat buddies; 4) moral injury from participating or witnessing killings, legal or otherwise; 5) intense survivor guilt, 6) co-occurring traumatic brain injury or phantom limb pain in amputees; 7) posttraumatic anger and sense of betrayal trauma; 8) handling of human remains; 9) being a prisoner-of-war by war enemy, drug cartel, or a political party; 10) chronic pain conditions; 11) opioid misuse; and 12) secondary trauma and compassion fatigue.

Similarly, war has taught us time and again that human beings have manifest traumatic stress injuries. These injuries cross a spectrum of possible conditions, and that diagnosis like PTSD represents only a sliver of possible afflictions.5 Historically, war or other traumatic stress injuries are often divided into 2 broad classifications: 1) neuropsychiatric conditions that consists of the culturally accepted diagnostic labels of the day such as PTSD, mood disorders, anxiety disorders, psychotic disorders, impulse control disorders, substance use disorders, neurocognitive disorders, eating disorders, sexual disorders, personality disorders, and others, and 2) medically unexplained physical symptoms (MUPS) which include chronic fatigue, headaches, chronic pain, atypical cardiac symptoms, idiopathic seizures, autoimmune conditions, and others.5

In the 21st century, the Department of Veterans Affairs states that MUPS, “such as chronic pain and fatigue, are common in the general and military veteran populations” and that “Chronic Fatigue Syndrome (CFS), Fibromyalgia (FM) and Irritable Bowel Syndrome (IBS) are among the most commonly diagnosed medically unexplained conditions.” However, there are far more potential MUPS diagnoses. These include noncardiac chest pain, pseudo seizures, multiple chemical sensitivity. Other studies on MUPS in the current war cohort indicate a high frequency of somatic complaints (Table 2).6 Additionally, OEF/OIF veterans with and without a diagnosed mental health condition were treated in the VA for 222 types of MUPS.7

As many clinicians are aware, somatic complaints are often considered a cultural idiom of distress.8 This is particularly true with military populations whereby stigma and fear of career reprisal can be so oppressive. The career-related stress makes it more likely to complain of headaches, back pain, and sleep problems as opposed to emotional symptoms.

Common Obstacles Military Populations Face to Receive Proper Mental Health Care

By far, the biggest obstacle that current and future military populations face regarding mental health care is the pattern of a sustained, self-inflicted mental health crises plaguing generations of Americans and society since World War I.9 These largely preventable catastrophes are caused primarily by chronic neglect and lack of accountability by the military and its government. Our most recent book noted 10 foundational lessons of war trauma identified by every military cohort since WWI. These lessons are essential to meeting the wartime mental health needs:

1) Recognizing that war inevitably causes large numbers of legitimate spectrum of war stress injury;

2) Adequate research, planning, and preparation are indispensable during both war and peace;

3) A large cadre of well-trained behavioral health specialists is compulsory during times of war and peace;

4) A holistic, public health approach to war stress injuries necessitates close collaboration with the private sector along with full mental health parity;

5) Effective mental health services demand the empowered leadership of an independent, unified, organizational structure, a behavioral Health Corps, providing integrated, well-coordinated continuity of care equal to medical services;

6) Elimination of mental health stigma, barriers to care, and disparity should be a priority for leadership, as it directly affects individuals, families, and military readiness;

7) Ensure ready access to high-quality mental health services, including definitive care prior to military separation or discharge;

8) Families must receive adequate mental health and social support during and after military service;

9) Accurate, regular monitoring and reporting are crucial for timely, effective, management of mental health needs; and,

10) Robust dedicated mental health “lessons learned” policy and programs are integral to meeting present and future needs and prevent crises.10

Despite being learned again at the end of every war, these lessons have not substantially improved veterans’ care. Perhaps the best evidence that little progress has been made comes from a Department of Defense (DOD) Task Force on Mental Health. In 2007 it identified11:

A single finding underpinning all others: The Military Health System lacks the fiscal resources and fully trained personal to fulfill its mission to support psychological health in PEACETIME or fulfill the enhanced requirements imposed during times of conflict (p. ES2).

And also13:

The time for action is now. The human and financial costs of un-addressed problems will rise dramatically over time. Our nation learned this lesson, at a tragic cost, in the years following the Vietnam War. Fully investing in prevention, early intervention, and effective treatment are responsibilities incumbent upon us as we endeavor to fulfill our obligation to our military service members.

This is a stirring plea for action, but the DOD offers no concrete proposal on where to start, or a sense of when we will know when it is enough. Without concrete proposals and ongoing commitment to investing in prevention, early intervention, and effective treatments, pleas like this one will remain empty.

Concluding Thoughts

Have we learned our lessons? More than 6 years into a shooting war, 99 urgent recommendations were made by the DOD task force, all reflecting neglect of the military’s well-documented centuries of “lessons learned.” The media, Congress, and Commander-in-Chiefs alike still have not met their responsibilities to investigate the reasons for gross negligence that harm countless members of the military population for this and future generations.

From our vantage point, the military is positioned in a unique leadership role within the broader society. It could inspire other leaders to step up, be accountable, and finally call for ending the stigma surrounding the mental health of its members. The question remains: why has the US government and its military refused to learn its war trauma lessons and what concrete actions are necessary to end the generational cycle of neglect and crises?

Dr Russell is a retired US Navy Commander and military clinical psychologist with more than 26 years of military service. Dr Figley is the Paul Henry Kurzweg, MD, Distinguished Chair in Disaster Mental Health at Tulane University and founder and director of the Tulane Traumatology Institute.

References

1. Grinker RR, Spiegel JP. Men Under Stress. Blakiston; 1945.

2. Vespa J. Those who served: America’s veterans from World War II to the War on Terror. US Census Bureau, U.S. Department of Commerce. June 2020. Accessed September 15, 2021.

3. Department of Veterans Affairs. Analysis of VA health care utilization among Operation Enduring Freedom, Operation Iraqi Freedom, and Operation New Dawn veterans, from 1st Qtr FY 2002 through 3rd Qtr FY 2015 (October 1, 2001—June 30, 2015). June 2015. Accessed September 15, 2021.

4. Russell MC, Figley CR. Psychiatric Casualties: How and Why the Military Ignores the Full Cost of War. Columbia University Press; 2021.

5. Russell MC, Figley CR. Generational wartime behavioral health crises: Part one of a preliminary analysis. Psychol Inj Law. 2015;8(1):106-131.

6. Hoge CW, Terhakopian A, Castro CA, et al. Association of posttraumatic stress disorder with somatic symptoms, health care visits, and absenteeism among Iraq war veterans. Am J Psychiatry. 2007;164(1):150-153.

7. Frayne SM, Chiu VY, Iqbal S, et al. Medical care needs of returning veterans with PTSD: their other burden. J Gen Intern Med. 2011;26(1):33-39.

8. Hinton DE, Lewis-Fernández R. Idioms of distress among trauma survivors: subtypes and clinical utility. Cult Med Psychiatry. 2010;34(2):209-218.

9. Russell MC, Figley CR. Investigating recurrent generational wartime behavioral health crises: Part two of a preliminary analysis. Psychol Inj Law. 2015; 8(1):132-152.

10. Russell MC, Figley CR, Robertson KR. Investigating the psychiatric lessons of war and pattern of preventable wartime behavioral health crises. Journal of Psychology and Behavioral Science. 2015;3(1):1-16.

11. Arthur D, MacDermid S, Kiley K, et al. An achievable vision: report of the Department of Defense Task Force on Mental Health. Department of Defense Task Force on Mental Health. Defense Health Board. June 2007. Accessed September 15, 2021.

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5 Top Tips for Preventing and Treating Pregnancy Back Pain from Jennifer Bright

Back pain is the bane of many female pregnancies. With weight gain, hormonal fluctuations, and a shift in focus, back pain is pretty inevitable.

If the pain is in the tailbone, it may help to sit on a donut pillow. This will give some space between your tailbone and the seat. Movement can help, especially walking. Besides exercising, take a rest whenever you can. A prenatal massage can often also relieve the pain.

One particular type of back pain is particularly bothersome. Sciatic nerve pain is excruciating pain that you feel in your buttocks and that radiate into the back of one or both of your legs. Sciatic pain can be caused by your uterus pressing on your sciatic nerve. The nerve can become inflamed, causing pain; Needles and pins; and even deafness.

You can try hot or cold compresses to relieve the pain. But the good news is that it should go away after your baby is born. If you try to prevent back pain now, you can feel good later.

Here’s what our mom doctors – doctors who are mothers too – do to prevent and treat back pain during pregnancy.

“During my pregnancy, I saw 35 patients a day,” says Mary Mason, MD, a mother of two, internist, and chief medical officer of a multi-state managed care company that cares for about 70,000 pregnant mothers on Medicaid coordinates a year. “I had some problems with back pain and thought that swimming helped a lot.”

“I’m four feet tall and I wasn’t the ideal weight gainer,” said Kathie Bowling, MD, mother of three grown sons and OB-GYN in private practice in Providence, Rhode Island. “I’ve gained 40 pounds with each pregnancy. (The ideal is 25, and most women put on between 35 and 40 pounds.) That was a lot of weight to drag around on my body. I had severe sciatic pain. One thing that helped was lying on the opposite side of my pain. “

“During the third trimester of pregnancy, I had sciatica, which is lower back pain that runs down the leg. There isn’t much you can do about that when you’re pregnant. I went to a massage therapist who specializes in treating pregnant women and let themselves be massaged. The massage helped a little – temporarily. But the hour was better relax and be pampered, “says Lezli Braswell, MD, mother of one daughter and two sons and a family doctor in Columbus, Georgia.

“The further I got along in my pregnancy, the more my back ached,” said Rallie McAllister, MD, MPH, mother of three, co-author of The Mommy MD Guide to Your Baby’s First Year, nationally recognized health expert and General Practitioner in Lexington, Kentucky. “Placing a pillow in my back while I sat helped my lower back, but it didn’t affect the muscle tension and pain that had built up in my neck and between my shoulders. Eventually, it occurred to me that my growing breasts were doing a lot of the strain on my upper back, and that my pre-pregnancy bra just wasn’t giving me enough support. “

“I wasn’t quite ready to wear a nursing bra, but I found that my heavier breasts didn’t put as much strain on my neck, shoulders and upper back by wearing a sturdy sports bra most of the time” adds McAllister, “I bought a few extra sports bras in my new size and found that I was much more comfortable wearing them at home and at work, and my muscles weren’t nearly as tired or tense by the end of the year Day.”

When to call the doctor

Tell your doctor or midwife if you experience back pain during pregnancy. If you have severe back pain or numbness, call your doctor or midwife immediately. Back pain can be a sign of premature labor.

Other symptoms of preterm labor include vaginal discharge, contractions, abdominal pain, and menstrual-like cramps. You should call your doctor or midwife right away if you suspect you are going into premature labor.

Jennifer Bright is a mother of four sons, co-founder and CEO of veteran family-owned custom publisher Momosa Publishing, co-founder of the Mommy MD Guides team of over 150 Mama MDs, and co-author of The Mommy MD Guide for the Toddler Years . “She lives in Hellertown, Pennsylvania. To learn more about Jennifer Bright and to read articles by other Creators Syndicate writers and cartoonists, visit the Creators Syndicate Web site at http://www.creators.com.

Photo credit: kalhh at Pixabay

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Green Canyon CBD Oil Reviews

Green Canyon CBD Oil Reviews – Pain Emancipation and Relief are some common goals shared by all of humanity. Losing chronic pain really brings more joy than anything else to someone who has been shaken in pain for a long time. With that, the fear that comes with it is another limitation to a joyful and happy life. There is no second thought that pain mimics both highly dull and extremely dull.

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If pain has also made your life boring, then you no doubt know the price of relief, which is enormous and often contains more chemicals than herbs. But now all of these are going to change for the best. Even if pain caused clinical depression, this even worse scenario can be corrected with Green Canyon CBD oil. This is the best gummy bear to use for the quick purpose of permanent relief.

What is Green Canyon CBD Oil ?:

Pain is not just a physical sensation, it is also psychological to a fantastic extent. Our mind can really feel its strength and the action our brain offers to the pain is tense. So more pain, more high blood pressure. Green Canyon CBD Oil modifies mental actions into pain to dilute worry, and then works to relieve physical pain from the bones. Currently, therapists have also started suggesting this for use as well as claiming that it is beneficial for the weak.

Special features of the rubber:

A quick and unbiased comparison, you will find that Green Canyon CBD oil is the first choice for all the specific products you have used for your precious bones. So you can shake off the others and rely entirely on this pure and serious supplement. Every facet of it is assessed and the dangers are in no way phased. After the item was originally introduced, there was actually no lonely time in which sales have ever declined. This clearly reveals its public value for pain relief.

Ingredients used:

Clove Oil – The clove component is great for preventing enzymes from becoming infected, which is why they usually help fight bacteria

Peppermint oil – this can be considered the main ingredient useful for quickly reducing puffiness

Boswellia – if the pain is not treated quickly, swelling can be triggered and this element also helps protect mobility

Regulations of the CBD gum:

A completely natural boost for the joints
It remains free from swelling
Lubrication made on a mineral basis
Preserves the tendons of the joint
Essentially helps reduce pain
Completely treats all pain
Double benefit for pain or anxiety
The cure for insomnia is made unique

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Advantages:

A very popular natural article
Neurogeneration or Security
Economics of costs
Disadvantage:

Visibility of a solid pepper scent
Do not use immediately after surgery
A limited selection of salable offerings
Scientific criteria of the brand new rubber:

With sophisticated technological oversight, this supplement is made in a purely risk-free environment and although made in the laboratory, it is healthy in nutrients and useful for the pain management function as well. Additionally, all of the vital minerals and oils were included as ingredients in Green Canyon CBD oil, making the product a completely trustworthy product in every way. So right now even seniors in extreme pain are preparing to use it without a doubt.

Customer opinions:

Cleaning up inquiries as well as providing suggestions for purchasing blog posts are an integral part of our overall advertising program. Because of this, the answers also contain the truth that after removing all of the questions, people were in a situation where they were much more dependent on Green Canyon CBD oil. Even the old users recommend this to their loved ones in need and thus the demand for the item has actually exceeded everything. You also need to be among those who share their priceless views and real comments on it.

Usage standards:

Confident that it will be the old folks who will make use of them, the shape of the gums has been poorly maintained and ready to be swiftly ingested. Such small steps go a long way towards ensuring that individuals have fun using them on a daily basis and eagerly anticipating them. With two applications a day, if you feel a little sleepy or dizzy, limit your dose to one afterwards. Also, keep in mind that with every missed dose of Green Canyon CBD Oil, you’ll have one less action to achieve a pain-free body.

Data protection and purchase plan:

The privacy of our customers is most important to us and therefore no information disclosed will be used without your consent. Our team offers the possibility of a personal conversation with the doctor in order to dispel any uncertainties about Green Canyon CBD Oil. It is convenient to use on any type of event day, and you can go all out whenever you really feel the demand. By referring to the comprehensive terms and conditions, you can steer clear of potential problems later and ultimately be quick when you are dying to buy.

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Last words:

In a week from now, it will be your real life experience that with each pain relief, the stress level will naturally decrease. No expensive chemical item can ever make you feel the way Green Canyon CBD oil does to you. Likewise, it’s most effective for people who don’t want to be afraid of side effects during the pain-free routine. We can come with the guarantee that this organic food supplement can change the rest of life. Just try it out asap and you too will be grateful and grateful for a lifetime to this fantastically functioning CBD gum!

Sources-

https://www.healthline.com/health/what-medicare-for-all-would-look-like-in-america
https://www.dietdoctor.com/recipes/low-carb-salmon-and-zoodles-in-blue-cheese-sauce
https://en.wikipedia.org/wiki/Health_care
https://www.everydayhealth.com/healthy-living/fitness/7-ways-speed-up-your-metabolism/
https://www.webmd.com/women/features/10-energy-boosters

Street No. 9
10001

Green Canyon CBD Oil Reviews – Pain Emancipation and Relief are some common goals shared by all of humanity. Losing chronic pain really brings more joy than anything else to someone who has been shaken in pain for a long time.

This press release was published on openPR.

Green Canyon CBD Oil Reviews was published on AmericanChiro

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