Neurological Conditions Now Leading Cause of Chronic Illness

By Pat Anson, PNN Editor

The number of people living with neurological conditions such as migraine, diabetic neuropathy, epilepsy, stroke and dementia has risen significantly over the past 30 years, making it the leading cause of chronic illness worldwide, according to a new analysis published in The Lancet Neurology.

An international research team estimates that over 3.4 billion people – about 43% of the global population – had a neurological condition in 2021, replacing cardiovascular disease as the leading cause of poor health.

“The worldwide neurological burden is growing very fast and will put even more pressure on health systems in the coming decades,” said co-author Valery Feigin, MD, Director of the National Institute for Stroke and Applied Neuroscience at Auckland University in New Zealand.

“Yet many current strategies for reducing neurological conditions have low effectiveness or are not sufficiently deployed, as is the case with some of the fastest-growing but largely preventable conditions like diabetic neuropathy and neonatal disorders. For many other conditions, there is no cure, underscoring the importance of greater investment and research into novel interventions and potentially modifiable risk factors.”

A total of 37 disorders affecting the brain and nervous system were included in the study. Collectively, the nerve disorders are responsible for 443 million years of healthy life lost due to illness, disability or premature death, known as disability-adjusted life years (DALYs).

Tension-type headaches (about 2 billion cases) and migraines (about 1.1 billion) are the two most common neurological disorders, while diabetic neuropathy is the fastest-growing one. Painful stinging or burning sensations in the nerves of the hands and feet are often the first symptoms of diabetes.

“The number of people with diabetic neuropathy has more than tripled globally since 1990, rising to 206 million in 2021,” said co-senior author Liane Ong, PhD, from the Institute for Health Metrics and Evaluation at University of Washington. “This is in line with the increase in the global prevalence of diabetes.”

Over 80% of neurological deaths and disability occur in low- and middle-income countries, with western and central sub-Saharan Africa having the highest DALY rates. In contrast, high-income countries in the Asian Pacific and Australasia regions had the lowest rates.

“Nervous system health loss disproportionately impacts many of the poorest countries partly due to the higher prevalence of conditions affecting neonates and children under 5, especially birth-related complications and infections,” said co-author Tarun Dua, MD, Unit Head of WHO’s Brain Health unit.

“Improved infant survival has led to an increase in long-term disability, while limited access to treatment and rehabilitation services is contributing to the much higher proportion of deaths in these countries.”

Medical providers specializing in neurological care are unevenly distributed around the world, with wealthy countries having about 70 times the number of specialists as low-income ones.

Researchers say prevention needs to be a top priority in addressing the growth of neurological conditions. Some disorders, such as stroke and chronic headache, are potentially preventable by lowering risk factors such as high blood pressure, smoking and alcohol use.

The study was funded by the Bill and Melinda Gates Foundation.

Study Finds Spinal Cord Stimulation Has No Benefit for Back Pain

By Pat Anson, PNN Editor

A scathing new Cochrane review is raising more questions about the safety, efficacy and long-term benefits of spinal cord stimulators, medical devices that are increasingly used to treat chronic back pain.  

Cochrane reviews are considered the gold standard in medical research because they use robust methodology to gather good quality evidence and reduce the impact of biased, poor-quality studies.

The review by Australian researchers concluded that spinal cord stimulation (SCS) works no better than a placebo for treating chronic low back pain, and provides little to no benefit in improving quality of life.

The devices are surgically placed near the spine and connected to batteries implanted under the skin, which send electrical impulses into the spine to mask pain.

“Spinal cord stimulation is invasive and has a great financial cost to people who choose surgery as a last resort to alleviate their pain. Our review found that the long-term benefits and harms are essentially unknown,” said lead author Adrian Traeger, PhD, a Research Fellow at the Institute for Musculoskeletal Health at the University of Sydney. “Our review of the clinical data suggests no sustained benefits to the surgery outweigh the costs and risks.”

Treager and his colleagues analyzed the results of 13 clinical trials of SCS devices, looking at data from almost 700 patients with low back pain. They found little to no clinical data on the long-term effectiveness of SCS because most of the studies lasted less than a month, were poorly blinded, or had selective reporting bias.

The researchers also found that side effects from SCS surgery were poorly documented, preventing them from assessing the level of risk involved. Serious adverse events include nerve damage, infection, and the devices’ electrical leads moving, all of which may lead to more surgeries.

“Data in this review do not support the use of SCS to manage low back pain outside a clinical trial. Current evidence suggests SCS probably does not have sustained clinical benefits that would outweigh the costs and risks of this surgical intervention,” they concluded. 

Findings from the Cochrane review have been submitted to Australia’s Department of Health and Aged Care, which is reviewing the effectiveness of spinal cord stimulators. The devices' long-term safety and performance are also being re-assessed by Australia's Therapeutic Goods Administration (TGA).

“Our review found that the clinical benefit of adding spinal cord stimulation to treat low back pain remains unknown. When coupled with the reality that these devices are very expensive and often break down there is clearly a problem here that should be of concern to regulators,” said Chris Maher, PhD, Co-Director of Sydney Musculoskeletal Health.

Increasing Use of Stimulators

About 50,000 spinal cord stimulators are implanted annually in the U.S. and their use is growing. The devices are no longer limited to patients with back, neck and leg pain. In 2021, the FDA expanded the use of SCS to treat chronic pain from diabetic neuropathy. Stimulators are also being used on patients with Complex Regional Pain Syndrome (CRPS).

A 2018 study by investigative journalists found that SCSs have some of the worst safety records of medical devices tracked by the FDA. A 2020 FDA review of adverse events involving stimulators found that nearly a third were reports of unsatisfactory pain relief. A more recent study found that patients with the devices did not reduce their use of opioids, and continued getting procedures such as epidurals, corticosteroid injections and radiofrequency ablation.

Although evidence is growing that questions the safety and effectiveness of SCS, medical device companies continue to roll out new stimulators with more advanced technology. This week Nevro said it would release the first SCS system in the U.S. that uses artificial intelligence to optimize pain relief for each patient. The HFX iQ SCS system is designed for patients with diabetic neuropathy or chronic back and leg pain.

"This is an exciting time in spinal cord stimulation -- better waveforms, more conditions we can treat, and a massive treasure trove of patient data," said Usman Latif, MD, an interventional pain specialist and consultant to Nevro.

“What if we could take all the programming experience and clinical outcomes of tens of thousands of patients across the country, including what programs worked and what didn't, and bring the power of all that knowledge into the palm of our patient's hand -- with them 24/7, monitoring them, and offering them the best program for their exact situation with a tap on the screen. HFX iQ is the future of medicine, where expanded data holds the promise of new capabilities and improved care."

In addition to the U.S. release of HFX iQ, Nevro has asked for approval from regulators in Europe and Australia.

FDA Approves Spinal Cord Stimulator for Diabetic Neuropathy

By Pat Anson, PNN Editor

Like many other people with diabetic neuropathy, Lee Cagle suffered from burning and stinging sensations in his legs – pain so severe that he used sheets at night to build a small tent around his feet so that the fabric didn’t touch his skin and trigger another flare.

The 33-year-old Arkansas man tried pain medications such as hydrocodone and gabapentin (Neurontin), but didn’t like their side effects or potential for addiction.

“I don’t want to get hooked on pain meds. I’ve seen people hooked on pain meds and I didn’t want that for myself,” Cagle told PNN. “I only used them on the worst of worse days, when I could not fall asleep because I was in so much pain.”

Last year Cagle heard about a clinical trial for people with painful diabetic neuropathy (PDN) and decided to take a chance, enrolling in the study to see if a Nevro spinal cord stimulator could relieve his pain. The device emits mild electrical pulses to disrupt pain signals before they reach the brain. 

“It was almost instantaneous. The ease of the pain that it gave me,” Cagle said. “I felt so much better.”

The results from his two-week trial were so promising that Cagle agreed to have the stimulator permanently implanted along his spine during an outpatient procedure. That was nine months ago.

“I’m a completely different person now, compared to what I was before I got it put in my back,” said Cagle, who had only one minor setback when one of the electrodes leading from the stimulator failed.      

Cagle was one of 113 patients with PDN who had Nevro stimulators implanted during the clinical trial. Several dropped out of the study due to adverse events such as infections and two had their devices removed.

Most of those who remained reported significant pain relief of at least 50% and improved quality of life.

NEVRO IMAGE

The overall results were so promising that the Food and Drug Administration recently approved Nevro’s Senza stimulators for the treatment of PDN, making it the only spinal cord stimulation system approved for that condition. The Senza stimulators are unique because they use high frequency electric pulses of 10 kHz, a frequency that doesn’t create an uncomfortable tingling sensation that’s common with other stimulators.

"The substantial pain relief and improved quality of life demonstrates that 10 kHz Therapy can safely and effectively treat this patient population," said lead investigator Dr. Erika Petersen, Professor of Neurosurgery and Director of Functional and Restorative Neurosurgery at the University of Arkansas for Medical Sciences. "I'm grateful to my co-investigators and the patients who participated in this study, as the results and this approval will have far-reaching impact on the lives of PDN patients."

‘Dangerously Lax’ Oversight

FDA approval of the Nevro stimulator for PDN is a significant expansion of the medical device market. Of the 34 million Americans with diabetes, about one in five have painful neuropathy, a condition that develops when high blood glucose levels damage peripheral nerves. Until now, most spinal cord stimulators were only approved for patients with severe back pain.

FDA approval also comes at a time when the agency is under growing scrutiny for its regulation of medical devices, particularly spinal cord stimulators. A 2020 report by Public Citizen accused the FDA of “dangerously lax” oversight of stimulators, which were linked to 156,000 injuries and 931 deaths. Ironically, the report noted that spinal cord stimulators are often touted as safer alternatives to opioid medication.  

“In the midst of the opioid crisis, medical device companies and medical centers that implant spinal cord stimulators increasingly have been marketing spinal cord stimulation as an alternative to opioids for chronic pain,” the report found. “Importantly, no evidence was provided that spinal cord stimulators reduce the use of opioids.”  

The FDA responded to the Public Citizen report by sending a letter to healthcare providers reminding physicians to only implant stimulators after a trial period that demonstrates the device provides effective pain relief. An FDA review of adverse events involving spinal cord stimulators found that nearly a third were reports of unsatisfactory pain relief. Even worse, the review identified nearly 500 deaths linked to the devices between 2016 and 2020.

A new study published this week in JAMA Internal Medicine concluded that the FDA’s adverse events reporting system for medical devices may significantly underestimate the number of deaths that actually occur. Researchers found the system relies too heavily on adverse events reported by device manufacturers.

The Center for Medicare Services (CMS) is also taking a harder look at spinal cord stimulators. On July 1, CMS implemented a new rule requiring Medicare patients to get prior authorization before a stimulator is implanted. The agency said there has been significant expansion in the use of spinal cord stimulators – about 50,000 are now implanted every year in the U.S. – but it could find no medical reason to justify the increasing number of procedures.

“After reviewing all available data, we found no evidence suggesting other plausible reasons for the increases, which we believe means financial motivation is the most likely cause," CMS said.

Industry groups and some members of Congress lobbied hard against the CMS rule, saying prior authorization would create “significant barriers to access to medically necessary procedures.”    

For patients who are desperate for pain relief, who find medication ineffective or difficult to obtain, spinal cord stimulation may be one of the few options remaining. Asked if he would recommend the Nevro stimulator to other DPN patients, Lee Cagle said he would.

“Definitely. Most definitely. I’m a totally different person now,” he said. “If Nevro came in with something else, if they needed me for a trial study, I wouldn’t hesitate.”  

Can a Low-Fat Diet Reverse Neuropathic Pain?

By Pat Anson, PNN Editor

Low fat diets are often recommended for people suffering from obesity and cardiovascular disease, but changes in eating habits are rarely recommended for people who live with chronic pain.

That could be changing thanks to a new study by researchers at the University of Texas Health Science Center, who found that diets high in omega-6 fats are strongly associated with inflammation and neuropathic pain. Omega-6 fats are widely found in typical Western diets of fast food, processed snacks, cakes, and fatty or cured meats.

Conversely, researchers say foods containing healthy omega-3 fatty acids – such as fish, flaxseed and walnuts – could reduce or even reverse neuropathic pain associated with diabetes. Their findings were recently published in the journal Nature Metabolism.

Diabetic neuropathy is a progressive and painful disease that causes burning or stinging sensations in the hands and feet. Many drugs used to treat neuropathic pain, such as gabapentin and pregabalin, often don’t work or have unpleasant side effects.

“This paper is a high-profile contribution for a huge unmet translational need as there are no treatments altering the nature of this neurological disease,” said José Cavazos, MD, director of the South Texas Medical Scientist Training Program at UT Health San Antonio.

In experiments on humans and laboratory animals, UT researchers found that mice fed a diet high in omega-6 polyunsaturated fats became hypersensitive to pain, cold and heat stimulation – signs of peripheral nerve damage. Lowering the amount of omega-6 fats and increasing omega-3 fatty acids reduced pain sensitivity in the mice.

The researchers also found that high levels of omega-6 lipids in the skin of patients with Type 2 diabetes were strongly associated with neuropathic pain and the need for analgesic drugs.

“We believe that these data warrant continued investigation of peripheral fatty acid and metabolite levels as potential pain biomarkers. Such biomarkers could provide clinicians with reliable objective endpoints to guide diagnoses as well as decision making on treatment regimens, including therapeutic diets,” wrote lead author Jacob Boyd, MD, UT Health San Antonio.

About 34 million people in the U.S. have diabetes and about half have some form of neuropathy, according to the American Diabetes Association.

A 2015 study found that a vegetarian diet coupled with vitamin B12 supplements significantly reduced pain and improved the quality of life of people with diabetic neuropathy. Participants also had lower blood pressure and cholesterol levels, and lost an average of 14 pounds.

FDA Approves Capsaicin Patch as Treatment for Diabetic Neuropathy

By Pat Anson, PNN Editor

Millions of patients with diabetic peripheral neuropathy live with burning or stinging pain in their hands and feet. In what could be called a case of fighting fire with fire, the U.S. Food and Drug Administration has approved the first use of a medicated patch made with capsaicin – the spicy substance that makes chili peppers hot – as a treatment for diabetic neuropathy.

The Qutenza skin patch is made by Grünenthal and contains 8% capsaicin, which acts on pain receptors in the skin by desensitizing and numbing nerve endings.

“Pain associated with diabetic neuropathy is an extremely challenging condition to diagnose, treat and manage effectively, which has a significant quality of life impact for many patients,” said David Simpson, MD, a Professor of Neurology at the Icahn School of Medicine. “In addition, patients are dissatisfied with unresolved pain and the side effects associated with current systemic treatments.”

A 2015 study found that Qutenza worked faster than pregabalin (Lyrica) in treating neuropathic pain, providing relief in 7.5 days, compared to an average of 36 days in patients taking pregabalin. Patients who used Qutenza were also more satisfied with their treatment and had fewer side effects.

That same year the European Commission approved Qutenza as a treatment for diabetic neuropathy, but it took another five years for the FDA to give its approval for the same condition. The patch was initially approved by the FDA in 2009 for treating post-herpetic neuralgia, a complication from shingles.

“Painful diabetic peripheral neuropathy has a significant impact on the day-to-day lives of millions of individuals, and we believe Qutenza can be a much-needed non-opioid treatment option for these patients,” Jan Adams, Grünenthal’s Chief Scientific Officer, said in a statement. “This expanded indication of Qutenza in the U.S. is an exciting milestone in our efforts to make Qutenza available to even more patients in need worldwide.”  

A big catch is that the patch shouldn’t be applied at home and should only be used sparingly. According to its warning label, Qutenza should be applied by a doctor or healthcare professional, who should be wearing a face mask and gloves to protect themselves in a well-ventilated area. Up to four patches can be applied on the feet for up to 30 minutes, a procedure that can be repeated every three months. The most common side effects are redness, itching and irritation of the skin where the patch is applied.

Qutenza has gotten mixed reviews from patients, who warned that capsaicin can cause painful burning sensations.

“Qutenza really does work. I did have very intense burning,” a patient posted in a review on Drugs.com. “The pain can be mind blowing but it does subside and a cool fan helps. Don't let your pets near the area as it will burn them. I have had multiple Qutenza and… it lasts up to 3 months plus. Don't apply yourselves. Use a health professional as it does burn.”

“Although I was informed about this treatment and how your body might react to it, my case spiraled out of hands,” another patient wrote. “The medics had to call a team to manage my situation. The pain was so much that without a shred of doubt words simply can not explain.”

Diabetic neuropathy is a progressive and debilitating complication of diabetes that affects more than 5 million Americans. Patients typically experience numbness, tingling or stabbing sensations in their hands and feet. More severe cases can result in foot ulcers, amputations and other complications.

Experimental Treatment Targets Neuropathic Pain

By Pat Anson, PNN Editor

Researchers in Denmark have developed a promising new compound to treat neuropathy that targets the hyper-sensitized nerves that cause chronic pain. The experimental compound – a peptide called Tat-P4-(C5)2 -- has only been tested in mice, but researchers hope to begin clinical trials on humans soon.

"We have developed a new way to treat chronic pain. It is a targeted treatment. That is, it does not affect the general neuronal signaling, but only affects the nerve changes that are caused by the disease," says Kenneth Lindegaard Madsen, PhD, Associate Professor at the University of Copenhagen.

"We have been working on this for more than ten years. We have taken the process all the way from understanding the biology, inventing and designing the compound to describing how it works in animals, affects their behaviour and removes the pain.”

Madsen and his colleagues recently published their findings in the journal EMBO Molecular Medicine .

The image below shows the compound Tat-P4-(C5)2 after it is injected into the spinal cord. The compound (purple) penetrates the nerve cells of the spinal cord (yellow), but not the surrounding cells (the cell nuclei are blue). The compound blocks neuropathic pain signals – the kind associated with diabetic neuropathy, shingles, phantom limb pain and chemotherapy-induced pain — from being sent to the brain.

UNIVERSITY OF COPENHAGEN

In a previous study, the researchers showed in an animal model that use of the compound can also reduce tolerance and the risk of addiction. They believe the compound will be more effective and safer than the anti‐convulsants, antidepressants and opioid medications now used to treat neuropathy.

"The compound works very efficiently, and we do not see any side effects. We can administer this peptide and obtain complete pain relief in the mouse model we have used, without the lethargic effect that characterises existing pain-relieving drugs," said Madsen.

"Now, our next step is to work towards testing the treatment on people. The goal, for us, is to develop a drug, therefore the plan is to establish a biotech company as soon as possible so we can focus on this."

What You Should Know About Neuropathy

By Barby Ingle, PNN Columnist

November is Nerve Pain Awareness Month. Or as we like to call it at iPain, “NERVEmber.”

There are dozens of chronic conditions that involve nerve pain. Neuropathy is a collection of disorders that occur when nerves of the peripheral nervous system are injured or damaged. The peripheral nerves are the ones outside of the brain and spinal cord — in our arms, legs, hands and throughout the body.

There are 3 types of peripheral nerves:  

• Autonomic nerves regulate biological activities that people do not control consciously such as breathing, digesting food and heartbeat. 

• Motor nerves control movements of muscles under conscious control such as walking, grasping things and talking.

• Sensory nerves transmit information about sensory experiences such as feeling a light touch or the pain resulting from a cut.

Some neuropathies affect all three types of nerves, others affect one or two types. Some of the diagnostic terms you might hear are predominately motor neuropathy, predominately sensory neuropathy, sensory-motor neuropathy and autonomic neuropathy.  

Neuropathy often causes pain, tingling or numbness in the hands and feet. Healthcare professionals had a longstanding belief that neuropathy pain is just a symptom of an illness and therefore not a disease. 

We now know that chronic nerve pain is a disease in itself, and the medical community and public are beginning to look at it in this way.

There are approximately 150 known types of neuropathy and the causes of many are not yet known.

Thirty percent of neuropathies are caused by diabetes, 30% are idiopathic or of an unknown cause, and the other 40% are attributed to autoimmune disorders, tumors, genetic, infections, environmental toxins and nutritional imbalances.

A great resource for patients is Dr. Norman Latov’s book, “Peripheral Neuropathy: When the Numbness, Weakness, and Pain Won't Stop.” This book helps us understand the causes of neuropathies in greater detail.

We need to increase awareness, conduct research, provide better clinical training, and better tools for diagnosing and treating neuropathy. Funding for neuropathy research is difficult to obtain because clinical professionals do not fully understand all of the complexities of neuropathy diseases and conditions. Far too often, if a patient does not have a known neuropathic condition, providers will say they could not possibly have a neuropathy.

Nerve Pain Is Not Just a Symptom

But neuropathy is not just a symptom of another disease, it can be a disease in itself.  When medical professionals fail to recognize the disease or causes of neuropathy, it leads to misdiagnosis, failure to diagnose, and delays in getting proper treatment. This can cause further damage to the patient.  

I have had some doctors tell me that neuropathy does not affect the upper body, hands or face, so I could not possibly have neuropathy and it must be something else going on. Know your limitations and your healthcare providers’ limitations. Sometimes it is difficult for them to understand all of our symptoms or the daily problems we face living with neuropathy.

It is important that we increase our communication skills as patients and caregivers. Better communication allows for better care and better answers. Too often our healthcare professionals stop short of proper diagnostic procedures due to assumptions, poor attitudes, and limited treatment options available to them. They also get pressure from insurance companies that limit payments for treatment and testing. Some providers also fail to understand the potential serious impact of these conditions going undiagnosed and undertreated.  

There are times when a doctor might believe that you can do something that you know will increase your symptoms or set off a flare. Communicate these limitations to your doctor and find out their knowledge of your condition.

Here are 5 tips to better access to proper and timely care.  

1. Seek credible information, keep your mind open to new treatments and provide copies of your research to your doctor when necessary. Remember – our providers see many patients day after day and do not always have the time to do research. You may be the first one to bring new information to them.

2. With better treatment options, we will be less frustrated as patients and can make greater progress in our goal to improve daily living.

3. Use a multidisciplinary approach to treatment. Include on your team of providers doctors who specialize in pain management, internal medicine, neuromuscular neurologists, physical therapists and psychologists/psychiatrists. Depending on the type of neuropathy you have, you may want to add doctors of immunology, radiology, oncology, hematology (liver), cardiology, pulmonology, orthopedics, urology, gastroenterology, podiatry, or other medical disciplines. 

4. When you read books by other patients or hear of new treatments in your social circles, be sure to have your own treating provider consult on those ideas. Patients are not one-size-fits-all. What works for someone else may not work for you.

5. Work with a healthcare provider who works with neuropathy patients on a regular basis. They tend to be more familiar with the daily challenges we face as patients.

Until research provides better answers and tools for diagnosing neuropathy, good doctor-patient communication is essential to diagnose and treat neuropathy in a timely manner.

Barby Ingle lives with reflex sympathetic dystrophy (RSD), migralepsy and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the International Pain Foundation. She is also a motivational speaker and best-selling author on pain topics. More information about Barby can be found at her website. 

This column is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.  

Few Drugs Effective in Treating Neuropathy Pain

By Pat Anson, Editor

Cymbalta and some other anti-depressants are moderately effective at relieving diabetic nerve pain, according to a new report by the Agency for Healthcare Research and Quality (AHRQ).

But researchers found little or no evidence that opioids, Lyrica, Neurontin and other widely prescribed medications are helpful in treating neuropathy pain.

Nearly 26 million Americans have diabetes and about half have some form of neuropathy, according to the American Diabetes Association. 

Diabetic peripheral neuropathy causes nerves to send out abnormal signals. Patients can feel stinging or burning pain, as well as loss of feeling, in their toes, feet, legs, hands and arms.

"Providing pain relief for neuropathy is crucial to managing this complicated disease," said lead author Julie Waldfogel, PharmD, of The Johns Hopkins Hospital in Baltimore.

"Unfortunately, more research is still needed, as the current treatments have substantial risk of side effects, and few studies have been done on the long-term effects of these drugs."

In a systematic review of over 100 clinical studies published in the journal Neurology, AHRQ researchers found moderate evidence that the SNRI antidepressants duloxetine (Cymbalta) and venlaxine (Effexor) were effective in reducing neuropathic pain. Nausea, dizziness and somnolence were common side effects of the drugs.

The evidence was weaker for anti-seizure medication such as pregabalin (Lyrica) and oxcarbazepine (Trileptal). Common side effects from those drugs are weight gain, dizziness, headache and nausea.

While pregabalin works in the same way as gabapentin (Neurontin) -- both are often used to treat nerve pain -- the reviewers found gabapentin was not more effective than placebo. The seizure drug valproate and capsaicin cream were also found to be ineffective.

Oxycodone was not effective in treating neuropathy pain, and the evidence was weak for two other opioids, tramadol and tapentadol.

The U.S. Food and Drug Administration has approved only three medications -- duloxetine, pregabalin and tapentadol -- for diabetic nerve pain. However, many others drugs are prescribed “off label” for the disease.

"We hope our findings are helpful to doctors and people with diabetes who are searching for the most effective way to control pain from neuropathy," said Waldfogel. "Unfortunately, there was not enough evidence available to determine if these treatments had an impact on quality of life.”

Researchers noted that all of the studies were short-term, many for less than three months, and even the most effective drugs had relatively high rates of side effects. They say longer-term studies are needed so that adverse effects and the continued effectiveness of the drugs can be assessed.

Is Cannabis Science's Pain Patch for Real?

By Pat Anson, Editor

A California company that claims to be developing a cannabis-based skin patch to treat chronic pain is “a fundamentally unsound company” with a long history of misleading the public and its own shareholders, according to analysts. The founder and former CEO of Cannabis Science has even accused the company’s current management team of fraud and deception.

At various times in its history, Cannabis Science has gone under the name Patriot Holdings, National Healthcare Technology, Brighton Oil & Gas, and Gulf Onshore. Now it has a slick new website, and is passing itself off as a pharmaceutical development company with a pipeline of cannabis-based drugs to treat asthma, HIV and chronic pain.

“I'm not sure if Cannabis Science is a biotech firm, an oil and gas exploration company, an educational university or a pot distributor, the only thing I am certain of is that Cannabis Science is in the business of moving money from public investors to executives' pockets,” wrote John Brody Gay in a lengthy analysis published by Seeking Alpha, an investing website.

Gay and other analysts say Cannabis Science is a classic “pump and dump” penny stock that produces little revenue, but a steady stream of press releases to promote its business activities, which never seem to come to fruition.

Often other websites are hired by pump and dumpers to publish their press releases or write glowing reviews about a company known as “advertorials.” Others are simply ignorant and don't do their homework. The publicity and fake news generates a brief flurry of interest in the company’s stock, which is when executives and other insiders often sell their shares. By raising the stock price by a few pennies, company insiders can double or triple the value of their holdings.

On November 2, Cannabis Science issued a press release saying it was developing skin patches to treat pain caused by fibromyalgia and diabetic neuropathy.

"The development of these two new pharmaceutical medicinal applications are just the tip of the iceberg for what we see as the future for Cannabis Science. While we strive to increase our land capacity for growth and facilities to produce our own product to supply our scientists with proprietary materials to make these formulations, we are also busy researching more potential needs for Cannabis related medical applications,” Cannabis Science CEO Raymond Dabney was quoted as saying in the news release.

Dabney is no stranger to accusations of deception and stock manipulation. In 2005, he admitted issuing 22 bogus news releases to promote another penny stock. For that he received a five year trading ban from British Columbia’s Securities Commission, according to Forbes and the Vancouver Sun.

A former CEO and president of Cannabis Science has also accused Dabney of fraud. Steve Kubby and other directors resigned after learning that Dabney, who was then working for Cannabis Science as a consultant, diverted company funds into a private account.

“When it became clear that our company had become entangled in fraud and deception, we demanded answers. Instead, those behind the fraud illegally removed me. Yes, we could have fought it and won, but attorneys repeatedly warned us that it is only a matter of time before the SEC will be investigating the company’s many questionable activities,” said Kubby in the Independent Political Report. “Actually, these guys have done me a great favor, because they have removed me from a stinking mess and assumed the liability for themselves.”

Kubby himself was accused by the company of "using unauthorized company shares as collateral or consideration for his personal gain."

Calls to Cannabis Science and Dabney for comment on the allegations were not returned.

‘Substantial Doubt’ About Company

The bottom line in all of this is that Cannabis Science is nearly broke and considers its own future questionable, which it discloses in its most recent financial statement to the Securities and Exchange Commission.

“The Company is not currently in good short-term financial standing. We anticipate that we may only generate limited revenues in the near future and we will not have enough positive internal operating cash flow until we can generate substantial revenues,” the company said. “There is substantial doubt as to the Company's ability to continue as a going concern without a significant infusion of capital.”

In the first six months of 2016, Cannabis Science reported revenue of only $5,787, and debt and liabilities of over $5 million.

What the company has plenty of is stock. Nearly two billion shares of Cannabis Science are currently trading on the over-the-counter “pink sheet” market, and the company is authorized to release another billion shares whenever it wants. It pays its executives, debtors and vendors in newly issued shares, which are typically sold at opportune times.  

Chief Financial Officer Robert Kane, for example, was paid with 20,000,000 shares on March 8. In October, Kane sold over 9 million shares for $384,000.

Nice work if you can get it.

With more and more states legalizing both medical and recreational marijuana, the cannabis industry is estimated to be worth $7 billion and growing quickly. So is the opportunity for fraud.

The Financial Industry Regulatory Authority (FINRA) warned about a profusion of marijuana stock scams three years ago, advice that still holds true today for investors, as well as pain patients.

“Like many investment scams, pitches for marijuana stocks may arrive in a variety of ways – from faxes to email or text message invitations, to webinars, infomercials, tweets or blog posts,” FINRA said. “The con artists behind marijuana stock scams may try to entice investors with optimistic and potentially false and misleading information that in turn creates unwarranted demand for shares of small, thinly traded companies that often have little or no history of financial success.”

Cannabis Science was out with yet another press release today, this one talking about its plan to build a 33,000 square foot marijuana greenhouse in Nevada. No details were offered on when the greenhouse would be built, how much it would cost, or who would pay for it.

"It is such an incredible feeling to see our great plans finally coming to fruition," Dabney was quoted as saying.

Kratom Helps Relieve My Neuropathy Pain

By Robert Dinse, Guest Columnist

I suffer from diabetic peripheral neuropathy.  I can best describe the pain as something akin to being doused in gasoline and then having a match tossed on me.  Pretty much everything from the neck down at times is involved in severe burning pain.

Over time I've been placed on a number of combinations of anti-depressants and anti-seizure medications with various degrees of effectiveness. Presently I am on Lyrica and nortriptyline, an anti-depressant.  So far this seems to be the best compromise between sedation and pain.

I actually got slightly better pain control with amitriptyline, another anti-depressant, but nortriptyline helps my mood more and since Lyrica negatively impacts my mood but greatly reduces my pain, this seems to be the best compromise.

With this combination of drugs, my pain is reasonably controlled about six days of the week, but I have periods, usually lasting 3-6 hours, of breakthrough pain in which I'm on fire again.

Kratom provides relief during those times and it does so without getting me high, or noticeably affecting my mental state in any way.  This leaves me almost pain free and totally functional.

robert dinse

There are two other drugs I've found to be helpful for this breakthrough pain. The first is marijuana, which is legal in Washington State but leaves me pretty much non-functional. I cannot drive, nor effectively do my work on enough marijuana to give pain relief.  Marijuana also stimulates my appetite and as a diabetic I need to lose weight, not gain weight.

The other useful drug is tianeptine sodium, but for it to be effective I need about 140 mg, which is higher than the maximum recommended single dose. At that dosage I also build a rapid tolerance.  Not a problem if the pain flare up is short, but if it lasts more than two days, which on rare occasions it does, then tianeptine sodium becomes ineffective. 

Some people get withdrawal symptoms from tianeptine sodium. I am fortunate that I have not ever experienced that, but it's lack of effectiveness if I get a bad flare-up lasting more than two days is its chief drawback.

I do not seem to rapidly build tolerance to kratom, and I've yet to experience any loss of effectiveness.  It doesn't get me high.  I don't get withdrawal symptoms. For my needs it is ideal, yet the DEA wants to take this away.

I wish that doctors and DEA officials could experience neuropathic pain firsthand so they could understand the hell their fouled up policies are putting people through. We have tens of thousands of deaths every year due to alcohol and tobacco, and the 16 alleged kratom deaths in the last five years all involved a mixture of other drugs that were most likely responsible for those deaths.

It is very hard to overdose on kratom because you take too much and you puke it up.  I have experimentally determined the puke up threshold for me is about 12 capsules, and 10 capsules totally relieve my pain with no sense of intoxication or impairment.

I don't know how you could ask a pain reliever to be simultaneously anywhere near as effective or safe as kratom.  Too much aspirin and you bleed to death internally, too much Tylenol and you toast your liver, many other NSAIDS readily available over the counter are bad for your heart.

Problem is, as a natural product, it's not patentable and thus competes with other patentable but much more dangerous and less effective drugs.

Robert Dinse lives in Washington State with his family.

Pain News Network invites other readers to share their stories with us.  Send them to:  editor@PainNewsNetwork.org. 

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Neuropathy More Damaging Than Previously Thought

By Pat Anson, Editor

A tingling, sometimes painful sensation in the hands and feet – the early stages of small fiber neuropathy -- may be more damaging to the peripheral nervous system than previously thought, according to new research published in JAMA Neurology.

A 3-year study by Johns Hopkins neurologists found that patients with small fiber neuropathy showed unexpected deterioration over the entire length of sensory nerve fibers, not just nerve fibers at the surface of the skin.

“I liken small fiber neuropathy to the canary in the coal mine,” says senior author Michael Polydefkis, MD, professor of neurology at the Johns Hopkins University School of Medicine and director of the Cutaneous Nerve Lab. “It signals the beginning of nerve deterioration that with time involves other types of nerve fibers and becomes more apparent and dramatically affects people’s quality of life. The results of this new study add urgency to the need for more screening of those with the condition and faster intervention.”

Nearly 26 million people in the United States have diabetes and about half have some form of neuropathy, according to the American Diabetes Association.  Small fiber neuropathy can also be caused by lupus, HIV, Lyme disease, celiac disease or alcoholism.

Diabetic peripheral neuropathy causes nerves to send out abnormal signals. Patients feel pain or loss of feeling in their toes, feet, legs, hands and arms. It may also include a persistent burning, tingling or prickling sensation. The condition can eventually lead to injuries, chronic foot ulcers and even amputations.

Polydefkis and his colleagues found that small fiber nerve damage occurs even in patients with prediabetes, and the early symptoms of burning pain may be less benign than most clinicians think. Routine nerve tests, like nerve conduction, often fail to identify nerve damage because they mostly assess injury to large diameter nerve fibers.

In an effort to measure nerve damage more accurately, Johns Hopkins researchers took small samples of skin — the size of a large freckle — from 52 patients diagnosed with small fiber neuropathy and from 10 healthy controls. Skin samples were taken from the ankle, the lower thigh near the knee and the upper thigh. Three years later, samples from the same area in the same patients were taken for comparison.

Microscopic analysis of the skin samples showed that patients with small fiber neuropathy initially had fewer nerve fibers on the ankle compared to the upper thigh, demonstrating the most nerve damage was further down the leg. But after three years, researchers found that longer nerve fibers were also lost from the lower and upper thighs, something that was not expected.

“We are all taught in medical school that the longest nerves degrade first, and we show that this isn’t always the case,” says lead author Mohammad Khoshnoodi, MD, assistant professor of neurology at Johns Hopkins,

Patients with prediabetes or diabetes had at least 50 percent fewer small nerve fibers in their ankles initially than those participants with an unknown cause for their small fiber neuropathy, indicating these patients started the study with more damage to their small nerve fibers.

The patients with prediabetes continued to have worsening damage to their small nerve fibers over the course of the study, losing about 10 percent of their nerve fiber density each year at all sites tested along the leg. Patients with diabetes also lost similar rates of nerve fibers along the three sites of the leg.

“I expected that people with diabetes would do worse, but I didn’t really expect people with prediabetes to experience a similar rate of degradation of their small nerve fibers,” says Polydefkis.

Researchers caution that their study was small, and that other factors such as high blood sugar, smoking, high blood pressure and high cholesterol, may also have contributed to the decline in nerve fibers.

Power of Pain: NERVEmber

By Barby Ingle, Columnist  

In a few short days Nerve Pain Awareness month begins – a global movement known in the pain community as NERVEmber.

I began the NERVEmber project in 2009 as a way to bring more attention to chronic nerve pain conditions such as Reflex Sympathetic Dystrophy (RSD/CRPS) and diabetic neuropathy. The term NERVEmber is derived from the burning pain people with neuropathy feel, combined with the month of November. 

The Power of Pain Foundation hosts the official NERVEmber project events each year. Since its inception, tens of thousands of nerve pain patients and organizations have signed on to help promote NERVEmber and bring awareness to the 150 plus conditions that have nerve pain as a symptom.  

The color orange is the international color for chronic pain awareness, which also fits right in with the fall colors we typically see.

Our largest spotlight throughout the month shines on RSD, which is one of the most painful conditions known to mankind. Yet, like many chronic pain conditions, RSD is misunderstood, mistreated and often misdiagnosed. 

Each day during the month of NERVEmber the Power of Pain Foundation will present an awareness task that we can all participate in. This year we are also giving away over $1,000 in prizes -- available to anyone who registers to participate and uses special hashtags on social media, completes daily tasks, and hosts or attends an event. The more you participate in official NERVEmber events, the more chances you have to win!

You can bring more awareness to conditions like RSD, CRPS and diabetes by posting every day in NERVEmber using social media tags on your posts such as @powerofpain and #PaintTheWorldOrange. Using these tags will earn participants chances to win some great prizes.

The Power of Pain Foundation and the #NERVEmber project is also supporting the #CRPSdayofaction, #RSDdayofaction, @theproject3x5’s, #OrangeInitiative,  #ColorTheWorldOrange, and #ColourTheWorldOrange. 

Official events include tasks shared on social media, wearing t-shirts, Paint the World Orange, and educational series.

The daily calendar of events are available here on the NERVEmber webpage.

One of our newest additions to the project is #painPOP. We are asking people to get involved by popping a balloon and challenging others to do the same or make a donation to help the Power of Pain Foundation continue our education, awareness and access to care programs.

We are asking participants to text, post or say something similar to, “I have the NERVE to be HEARD!"

We will also be posting educational videos on YouTube and our website. Watching videos and commenting on them gives participants more ways to win great prizes. For #PaintTheWorldOrange, we ask participants to post their #NERVEmber pictures on social media and to share your pics as you #PaintTheWorldOrange. Be sure to hashtag it #NERVEmber #PaintTheWorldOrange to increase awareness and your chances to win POP prizes.

Participants are also invited to create graphics of their own using #NERVEmber and #PaintTheWorldOrange. Don’t forget to WEAR ORANGE all month long! You can upload your orange photos to help us paint the world.

Tens of thousands have participated in past years from around the world and we are expecting even more this year. Don’t miss out on being part of a movement to make a difference.

For more information on NERVEmber visit http://powerofpain.org/nervember

Barby Ingle suffers from Reflex Sympathetic Dystrophy (RSD) and endometriosis. Barby is a chronic pain educator, patient advocate, and president of the Power of Pain Foundation. She is also a motivational speaker and best-selling author on pain topics.

More information about Barby can be found at her website.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Wear, Tear & Care: The Quell Pain Relief Device

By Jennifer Kain Kilgore, Columnist

When presented with the Quell pain relief device, people make one of two assumptions about me: 1.) I injured my knee, or 2.) I am a paroled felon wearing a very forgiving Velcro GPS.

As I said in my recent guest column, I have made it my mission to test as many pain relief products and therapies as possible. Some of them might be familiar to you; others will be of the “new and bizarre” variety. Whatever they are, I will be your Friendly Neighborhood Guinea Pig and review them for your convenience. I only draw the line at “Made for TV” products that are out to swindle the desperate consumer.

Pain patients are certainly desperate. We have a constant refrain humming through our bodies that plays a different tune for each person. Doctors are the musicians taught to hear those tunes -- but how can they possibly learn all the music? How can they hear your specific song and have the knowledge necessary to fix it?

The problem is that sometimes they cannot. They are deaf to your pain, just like that one whale who sings higher than every other whale -- none of them can hear her.

Thus far, doctors have been unable to hear the song that thrills along my nerve endings. This leaves me with no choice but to fend for myself. I could take the route at which they have hinted: find some street drugs and wait for the undertow to take me (not that this is the problem the media makes it out to be). Or I could travel a different road and at the same time realize that this life of mine includes pain. If I can’t get rid of it, I can at least muffle it.

image courtesy of neurometrix

As I said recently in my blog -- Wear, Tear, & Care -- I have been trying the Quell pain relief device, which is made in the great state of Massachusetts (i.e., my backyard). I have been using it every day for more than a month. Here are my findings:

• It absolutely works. I have been wearing it for 35 days. I assume there was some psychosomatic effect at first because I was so excited to try the device after months of hype. Once the initial thrill wore off, I was left with the knowledge that, yes, I have reduced my number of Motrin from 16 a day to four, give or take. I am still on Cymbalta and Lyrica for pain control and situational depression, though I can now contemplate reducing the Lyrica entirely. Before, that was not even a possibility.
• Wearing any kind of medical device during the summer is difficult. I can make the Stride of Pride and show if off with a skirt or shorts; otherwise I have to find pants under which the device can comfortably fit. This means that a good portion of my wardrobe (leggings, skinny jeans, etc.) is not compatible with the Quell. This is a minor concern.
• The Quell is $249.00. Replacement electrodes cost $30 and last for two weeks. I have worn mine for longer than that because A.) I can, and B.) I’m cheap. The electrodes break down quickly, but as a whole they are more durable than traditional electrodes and do not irritate my skin. With the EMPI device, the electrodes left blisters on my back.
• The iPhone app is quite lovely. It has a countdown clock so you can see how long the therapy has lasted or how far away it is. I have become adept at the internal calculation of 60 minutes on, 60 minutes off.
• Unlike other TENS devices I have tried, the stimulation is not distracting, so wearing it at the office is fine.

This is all well and good. But how does the Quell work?

According to their research paper presented to the FDA, the Quell works not unlike other devices that latch onto a dense cluster of nerves in the upper calf. Generally it is best for lower-body pain (sciatica and the like), diabetic neuropathy, and fibromyalgia. I myself have fibromyalgia-ish symptoms, since my pain radiates all over my body. However, I apparently do not actually have the inflammation that is fibro’s hallmark. Doctors will only commit to “chronic pain syndrome.” Since the device works for me, I can say confidently that it treats more than those three conditions.

The Quell is twice as strong as conventional TENS units, does not irritate the skin like traditional electrodes, is less conspicuous, has a mobile app, and can be worn at night. (They say it can be worn at night; I personally found the stimulation too distracting.) It activates endogenous opioids in the body (natural opioids, to say it in English), a different system than the one on which prescription opiates work.

It is, simply put, a wearable intensive nerve stimulator that follows the Pain Gate Theory: The impulses generated by the Quell block pain signals from reaching the brain. As it was cleared to be sold over-the-counter, it is currently not covered by insurance.

I know you pain patients out there loathe the numbers system (What is your pain on a scale of 1 to 10?). I also despise it; this is the only one that has come close to working for me. That’s why I have created a new system. Instead of assigning an arbitrary number to my pain, I am going to tell you what I can do now that I couldn’t do before.

1. I can cut down my daily over-the-counter medication.

2. I can walk for longer periods of time (36 days ago I could walk about 10 minutes before starting to limp; now I can make it almost 30 minutes).

3. I can sit for longer periods of time during the work day (prior to the Quell I’d last 10 minutes before having to get up and move around; now I can make it to 30 before movement becomes necessary).

4. I can focus better on immediate tasks.

5. I have more energy during the daytime, which makes me more social. I have been hanging out with friends more. However, I still practice the chronic pain version of sundowning in the evenings (i.e., I crash).

6. I have been able to resume my almost-daily yoga practice. I even did a 55-minute video the other day (which was   Aroga Yoga’s yoga class for those with chronic illness).

7. I have been able to resume my aqua aerobics practice two to three times per week.

8. I wear my emergency back brace less frequently.

9. I have fewer flares.

FINAL DIAGNOSIS: The Quell device has worked brilliantly for me. While it doesn’t get rid of all the pain I feel, it dampens enough of it so that I can more fully live my life. I hope that it can bring others as much relief.

Jennifer Kain Kilgore is an attorney in the Greater Boston area who also works as a writer and editor in her spare time.  She has chronic back and neck pain after two car accidents. 

You can read more about J.W. on her blog, Wear, Tear, & Care.  

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Marijuana Effective for Diabetic Neuropathy Pain

By Pat Anson, Editor

New research shows that inhaled medical marijuana can significantly reduce pain from diabetic neuropathy within minutes of treatment.

The study, published in The Journal of Pain, also found there was a dose dependent reduction in pain depending on the strength of marijuana used.

Researchers at the University of California San Diego followed 16 patients with diabetic peripheral neuropathy (DPN) in a double-blind study as they were exposed to low, medium and high doses of tetrahydrocannabinol (THC), the psychoactive compound in marijuana that makes people “high.”

Patients used a Volcano vaporizer to inhale marijuana with 1%, 4% and 7% THC, as well as a placebo. A vaporizer was used because it is less harmful than smoking and delivers THC into the bloodstream rapidly.

“We hypothesized that inhaled cannabis would result in a dose-dependent reduction in spontaneous and evoked pain with a concomitant effect on cognitive function,” said lead author Mark Wallace, MD, professor of anesthesiology, University of California San Diego School of Medicine. 

Results showed that the highest dose of THC reduced pain by nearly 70%, with the analgesic effect starting within minutes of inhaling and reaching its peak about an hour after treatment. The analgesic effect of the low and medium doses of THC was slightly lower.

All of the patients experienced either euphoria or somnolence, regardless of the dose, with modest effects on attention, memory and impairment.

“These findings along with previous studies suggest that cannabis might have analgesic benefit in neuropathic pain syndromes, including treatment-refractory DPN,” said Wallace.

Nearly 26 million people in the United States have diabetes and about half have some form of neuropathy, according to the American Diabetes Association.  Diabetic peripheral neuropathy causes nerves to send out abnormal signals. Patients feel burning, tingling or prickling sensations in their toes, feet, legs, hands and arms.

There are only two drugs approved by the Food and Drug Administration to treat DPN -- Cymbalta and Lyrica – and many patients say they don’t work or have unpleasant side effects.

Marijuana Helps Heal Broken Bones

Meanwhile, researchers in Israel have discovered that a compound in marijuana can help heal fractures and rebuild bones.

In an animal study published in the Journal of Bone and Mineral Research, researchers at Tel Aviv University reported that cannabinoid cannabidiol (CBD) – a non-psychoactive ingredient in marijuana – significantly enhanced the healing process in rats with broken legs.

Earlier studies by the same research team found that cannabinoid receptors in the human body stimulate bone formation and inhibit bone loss. The findings suggest that cannabinoid based drugs could be used to treat osteoporosis and other bone-related diseases.

"The clinical potential of cannabinoid-related compounds is simply undeniable at this point," said Dr. Yankel Gabet of the Bone Research Laboratory at the Department of Anatomy and Anthropology at Tel Aviv University.

The researchers injected one group of rats with CBD alone and another with a combination of CBD and THC. They found that CBD by itself provided the most therapeutic benefit.

"We found that CBD alone makes bones stronger during healing, enhancing the maturation of the collagenous matrix, which provides the basis for new mineralization of bone tissue," said Gabet.

"Other studies have also shown CBD to be a safe agent, which leads us to believe we should continue this line of study in clinical trials to assess its usefulness in improving human fracture healing.”

‘Amazing’ New Stem Cell Treatment for Neuropathy

By Pat Anson, Editor

Researchers at Duke University say an experimental stem cell therapy being tested on animals shows great potential to provide long-lasting pain relief for people suffering from diabetic neuropathy or other types of nerve damage.

In a study published in the Journal of Clinical Investigation, researchers said mice injected with a type of stem cell known as bone marrow stromal cells (BMSCs) were much less sensitive to nerve pain.

"This analgesic effect was amazing," said Ru-Rong Ji, PhD, a professor of anesthesiology and neurobiology in the Duke School of Medicine. "Normally, if you give an analgesic, you see pain relief for a few hours, at most a few days. But with bone marrow stem cells, after a single injection we saw pain relief over four to five weeks."

BMSCs are known to produce an array of healing factors and can be coaxed into forming other types of cells in the body. They are already being used to treat people with serious burns, inflammatory bowel disease, heart damage and stroke.  

"Based on these new results, we have the know-how and we can further engineer and improve the cells to maximize their beneficial effects," said Ji.

Researchers injected the mice with stem cells through a lumbar puncture, infusing them into the fluid that bathes the spinal cord.

The picture on the right shows how the injected stem cells (in red) migrated to the site of the nerve injury and were still present four weeks after treatment.

A molecule emitted from the injured nerve cells -- which has previously been linked to neuropathic pain – is believed to act as a “homing signal” and attract the stem cells.

Researchers measured levels of anti-inflammatory molecules in the mice and found that one in particular, TGF-β1, was present in higher amounts in the spinal fluid of the stem cell-treated animals.

TGF-β1 is a protein that is secreted by immune cells and is common throughout the body. Research has shown that people with chronic pain have too little TGF-β1.

courtesy duke university

Injecting TGF-β1 directly into spinal cord fluid provides pain relief, but only for a few hours, according to Ji. By contrast, bone marrow stromal cells stay on site for as much as three months after the infusion.

Ji’s research team is working to identify stem cells that produce more TGF-β1, as well as other types of pain relieving molecules. In addition to diabetic neuropathy, researchers believe stem cell therapy could also be used to treat pain from chemotherapy, surgical amputation, lower back pain and spinal cord injuries.

Nearly 26 million people in the United States have diabetes and about half have some form of neuropathy, according to the American Diabetes Association.  Diabetic peripheral neuropathy causes nerves to send out abnormal signals. Patients feel pain or loss of feeling in their toes, feet, legs, hands and arms. It may also include a persistent burning, tingling or prickling sensation. The condition can lead to injuries, chronic foot ulcers and even amputations.

Another recent animal study by researchers in the U.S. and South Korea found that diabetic rats given intramuscular injections of bone marrow stromal cells experienced both angiogenesis (blood vessel growth) and a restoration of the myelin sheath -- a protective covering over nerve cells damaged by neuropathy.

"Currently, the only treatment options available for DN (diabetic neuropathy) are palliative in nature, or are directed at slowing the progression of the disease by tightly controlling blood sugar levels," said Dr. John Sladek, Jr., Professor of Neurology, Pediatrics, and Neuroscience, Department of Neurology at the University of Colorado School of Medicine.

"This study offers new insight into the benefits of cell therapy as a possible treatment option for a disease that significantly diminishes quality of life for diabetic patients.”

The study is being published in the journal Cell Transplantation.