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.

Good Attitude Improves Effectiveness of Yoga and Physical Therapy

By Pat Anson, PNN Editor

Yoga is a four-letter word for a lot of chronic pain patients, who are often urged to try yoga or physical therapy to ease their pain. Many pain sufferers believe exercise will only make their pain worse.

But a new study by researchers at Boston Medical University found that people with chronic lower back pain are more likely to benefit from yoga and physical therapy if they have a positive attitude about exercise.

The study involved 299 mostly low-income patients with chronic lower back pain who took weekly yoga classes or had physical therapy for 12 weeks. They were compared to a control group who had “self-care” – which consisted of reading a handbook on self-management strategies for back pain, such as stretching and strengthening exercises.

Nearly half (42%) of those who had yoga or physical therapy responded to the treatment, while only 23% of those in the self-care group had improvement in their pain and physical function.

Interestingly, participants who continued taking pain medication during the study were more likely to benefit from yoga (42%) than those who had physical therapy (34%) or self-care (11%).

"Adults living with chronic low back pain could benefit from a multi-disciplinary approach to treatment including yoga or physical therapy, especially when they are already using pain medication,' said lead author Eric Roseen, DC, a chiropractic physician at Boston Medical Center.

Another important finding from the study, which was published in the journal Pain Medicine, is the effect that “fear avoidance” can have on patient outcomes.

Among the participants who had less fear of exercise, 53 percent responded to yoga, 42 percent responded to physical therapy and 13 percent responded to self-care. In contrast, participants who had a high fear of exercise usually had a poor response, regardless of what therapy group they were in.  

Other factors that appeared to improve patient response were a high school education, higher income, employment and being a non-smoker.

"Focusing on a diverse population with an average income well below the U.S. median, this research adds important data for an understudied and often underserved population," said Roseen. "Our findings of predictors are consistent with existing research, also showing that lower socioeconomic status, multiple comorbidities, depression, and smoking are all associated with poor response to treatment."

It doesn’t take a lot of time to benefit from exercise. A 2017 study found that just 45 minutes of moderate physical activity a week improved pain and function in patients with osteoarthritis.

A few weeks of yoga significantly improved the health and mental well-being of people suffering from arthritis, according to a 2015 study at Johns Hopkins University.

Virtual Reality Therapy Can Reduce Chronic Pain at Home

By Pat Anson, PNN Editor

Therapeutic virtual reality (VR) can reduce chronic pain, improve mood and help people sleep, according to a small study of 74 patients living with fibromyalgia or chronic lower back pain.

The research, published online in JMIR-FR, is one of the first to look at the effectiveness of VR therapy when self-administered at home by chronic pain patients. It was funded by AppliedVR , a Los Angeles based company that is developing therapeutic VR content to help treat pain, depression, anxiety and other conditions.

“People with chronic pain often have limited access to comprehensive pain care that includes skills-based behavioral medicine. We tested whether VR that was self-administered at home would be an effective therapy for chronic pain,” said Beth Darnall, PhD, a pain psychologist who is AppliedVR’s chief scientific advisor.

“We found high engagement and satisfaction, combined with clinically significant reductions in pain and low levels of adverse effects, support the feasibility and acceptability for at-home, skills-based VR for chronic pain.”

Participants in the study were given VR headsets and instructed to have at least one session daily for 21 days. Half of the patients listened to audio-only programming, while the other half watched “virtual” programs in which they could swim with dolphins, play games or immerse themselves in beautiful scenery.

The programs are designed to help patients learn how to manage their pain and other symptoms by using cognitive behavioral therapy (CBT) to distract them and make their pain seem less important.

A sample of what they saw can be seen in this video:  

At the end of the study, 84 percent of the patients reported they were satisfied with VR therapy, which worked significantly better than the audio-only format in reducing five key pain indicators:

• Pain intensity reduced an average of 30%

• Physical activity improved 37%

• Mood improved 50%

• Sleep improved 40%

• Stress reduced 49%

Previous VR studies have had similar findings, but have largely focused on patients in hospitals and clinical settings. 

“This study is a fundamental step for advancing a clinically proven, noninvasive and safe digital therapeutic like VR for chronic pain, and demonstrates our platform is both viable and efficacious,” said Josh Sackman, co-founder and president of AppliedVR.

“Living with and managing chronic pain daily can be a debilitating and costly challenge, and many patients suffering from it can feel hopeless and desperate for any relief. So, as we engage in and accelerate more in-depth clinical research, we want them to know that we’re committed to making VR a reimbursable standard of care for pain.”

AppliedVR products are being used in hundreds of hospitals, but are currently only available to healthcare providers. The company recently partnered with University of California at San Francisco to study how VR therapy can improve patient care for underserved populations.

AppliedVR is also conducting two clinical trials to see if VR therapy can reduce the use of opioid medication for acute and chronic pain. The National Institute on Drug Abuse recently awarded nearly $3 million in grants to fund the trials.

The company is currently recruiting patients with chronic lower back pain for an 8-week trial of VR therapy. Headsets and other material will be mailed at no cost to participants at their homes. No in-person visits are required.  

VA Studying Laughing Gas as Treatment for Veterans With PTSD

By Pat Anson, PNN Editor

The U.S. Department of Veterans Affairs is sponsoring a small study to see if nitrous oxide – commonly known as laughing gas – could be used as a treatment for veterans suffering from post-traumatic stress disorder (PTSD), pain and depression.

The placebo-controlled Phase 2 study will be held at the VA Palo Alto Health Care System in California this fall. Investigators plan to recruit 104 veterans with PTSD to participate. Half would inhale a gaseous mix of nitrous oxide and oxygen, while the other half would be given a placebo.

Although PTSD is the primary focus of the study, researchers also hope to learn if nitrous oxide could be used to treat pain and other symptoms.

“Specifically, the investigators will first assess whether nitrous oxide treatment improves PTSD symptoms within 1 week. In parallel, the investigators will explore whether the treatment improves co-existing depression and pain,” researchers said. “In addition, the investigators will explore nitrous oxide's effects on a PTSD-associated impairment that is often overlooked - disruption in cognitive control, a core neurobiological process critical for regulating thoughts and for successful daily functioning.”

Military veterans suffering from PTSD often experience pain, anxiety, anger and depression. About one in five veterans who served in the Iraq or Afghanistan wars developed PTSD within a year of coming home.

In a small pilot study funded by the VA, three veterans with PTSD inhaled a single one-hour dose of nitrous oxide through a face mask. Within hours, two of the patients reported a marked improvement in their symptoms. The improvement lasted one week for one patient, while the second patient's symptoms gradually returned over the week. The third patient reported an improvement two hours after his treatment, but his symptoms returned the next day.

"While small in scale, this study shows the early promise of using nitrous oxide to quickly relieve symptoms of PTSD," said anesthesiologist Peter Nagele, MD, chair of the Department of Anesthesia & Critical Care at University of Chicago Medicine and co-author of a study recently published in the Journal of Clinical Psychiatry.

Nitrous oxide is a colorless and odorless gas that is commonly used by dentists to manage pain and anxiety in patients. It was once widely used in American hospitals to relieve labor pain, but fell out of favor as more Caesarean sections were performed and women opted for epidural injections and spinal blocks.

Some hospitals are now reintroducing nitrous oxide as a safer and less invasive option. The gas makes patients less aware of their pain, but does not completely eliminate it.  Recent studies have shown that about 70% of women who receive nitrous oxide during labor wind up using another analgesic due to inadequate pain relief.

"Like many other treatments, nitrous oxide appears to be effective for some patients but not for others," explained Nagele. "Often drugs work only on a subset of patients, while others do not respond. It's our role to determine who may benefit from this treatment, and who won't."

If findings from the VA’s pilot study are replicated in further research, it may be feasible to use nitrous oxide for rapid relief from PTSD, while longer-term treatments like psychotherapy and pharmaceutical drugs are also implemented.

FTC Takes Dim View of Light Therapy Device

By Pat Anson, PNN Editor

Low level light therapy (LLLT) – also known as “laser therapy” – has been touted for years as a treatment for arthritis, neck and back pain, fibromyalgia, neuropathy and even spinal cord injuries.

But in the first case of its kind, the Federal Trade Commission is going to court to get the makers of a light therapy device called the Willow Curve to stop making deceptive claims that it can treat chronic pain.

“When LLLT sellers say their devices will relieve pain, they’d better have the scientific proof to back it up,” Andrew Smith, Director of the FTC’s Bureau of Consumer Protection, said in a statement. “People looking for drug-free pain relief deserve truthful information about these products.”

In a complaint filed in federal court against the inventors and marketers of the Willow Curve, the FTC alleges that Dr. Ronald Shapiro and David Sutton “personally made deceptive claims about the health benefits” of the device and falsely claimed it was approved by the Food and Drug Administration to treat chronic pain, severe pain and inflammation.

Willow Curve is a curved plastic device that delivers low-level light and mild heat to painful areas. It’s been sold online and through retailers and healthcare professionals since 2014, most recently at a price of $799.

In a 2016 commercial, television personality Chuck Woolery said the Willow Curve offers “drug free pain relief for the digital age” and personally promised that “the Curve could change your life.”

Other advertisements tout Willow Curve as “clinically proven” and the “world’s first digital biosensory, biotherapeutic laser smart device” — even though there is no scientific evidence to support those claims, according to the FTC complaint.

The FTC also alleges that Shapiro and Sutton deceptively claimed Willow Curve comes with a “risk free money back” guarantee. In reality, consumers who returned the device had to pay shipping and handling costs, and often did not receive a refund at all or had to wait more than a year to get their money back.

The settlement imposes a $22 million judgment against the defendants, which will be partially suspended if Shapiro and Sutton each pay $200,000. It also asks the judge to issue a permanent injunction to prevent future false advertising of the Willow Curve. The complaint was filed in the U.S. District Court for the Eastern District of Michigan.

What Pain Rules Are You Following?

By Ann Marie Gaudon, PNN Columnist

As part of his pioneering work on behavioural analysis, psychologist B.F. Skinner coined the term “rule-governed behaviour” in 1966.

We all live by rule-governed behaviours, they’re part of our learned history. For example, a young child can be told “never touch a hot stove” and they will not. Most people don’t need to suffer the consequence of being burned by a hot stove because we are able to learn the lesson from our language abilities.

Other rules may include judgments about ourselves, our environment and about others, which can lead to behaviours that make our lives more -- or less -- enjoyable.

When living with chronic pain, our minds give us no shortage of rules. Creating rules about pain is one way that our minds process and react to it. Why? It’s because our minds are always trying to protect us, to keep us safe, alive and as pain-free as possible..

However, the mind doesn’t discriminate and can be maladaptive. Some rules will be very helpful (“I must avoid certain foods due to colitis”) and some will be completely arbitrary and unhelpful (“I must avoid all types of exercise because of a torn rotator cuff”).

The problem with buying into some rules, or treating them as if they were the literal truth, is that we find ourselves going over the same self-defeating tracks over and over again. One simple sentence can take on colossal dimensions.

“Beth” will be our pain patient of the day. She has a torn rotator cuff and has taken on the sole identity of “chronic pain patient” to the exclusion of all other roles in her life. It’s become a real problem. Take a look at the rules Beth has developed for herself due to chronic pain:

“I can’t work if I’m in pain.”

“Feeling pain is unacceptable. I can’t live a good life with that feeling.”

“It simply isn’t fair that I should suffer with this.”

“Exercising will make the pain worse.”

As a result of Beth buying into these rules, what do you think her life has become? If you think that Beth has locked herself up tightly in a “pain chain,” then you are correct. Her suffering has gotten worse from this type of “dirty pain.”

You may have noticed that some of Beth’s rules are patently absurd. There is no fault to be found here. Our minds are rule makers and problem-solving machines – even when the problem is thus far unsolvable (chronic pain). Beth is not yet aware of how her mind’s reactions to her pain are choking off her life, and not yet aware that there are strategies to help her free herself.

As a professional therapist, I would not be telling Beth her rules are true or false, and I would encourage her to do the same. That self-argument would be unproductive: “I am unlovable”…”Yes I am lovable”… “No I am not”… and so on.

A debate like that is not helpful. Instead, I would be asking Beth questions in an attempt to put some metaphorical space between her and her maladaptive rules. You can ask yourself these same questions about your own limiting rules.

Can you identify your overall pain rule and can you name it? Nothing can be done about these restrictions until you become aware of them and can identify them yourself.

Do you notice what happens when you follow this rule? It is highly likely that when you follow the rule your anxiety and distress will go down in the short-term. However, in the long-term, your behaviour will become more and more rigid. You will have much less choice in your life and move far away from a life that you value. Relationships with yourself and others will pay a high price. Your suffering will increase exponentially.

Can you look at this rule in terms of workability? If you continue to follow this rule, is this a workable solution to your suffering? Will this be helpful to you to live a richer, more meaningful life? Are the long-term costs worth the short-term payoff?

Are you prepared to make a choice?  You cannot stop the rule from popping into your mind, but you do have a say in how you respond. Will you follow this rule or choose to do something different? Will you bend or change the rule? Will you be flexible?

Do you notice what happens with your choice? If you choose to follow the rule, where does that take you? If you choose something different, where does that lead to?

This type of self-exploration would be a first step in addressing Beth’s restrictive rules and the consequences of blindly following them. Learning to choose new rules to influence her behaviour is akin to laying down new tracks over the old detrimental ones.

Beth will do well to acquire all of the tools she can to help her to live a better life, alongside the challenges she faces from chronic pain. Psychotherapy is one of those tools.

Ann Marie Gaudon is a registered social worker and psychotherapist in the Waterloo region of Ontario, Canada with a specialty in chronic pain management.  She has been a chronic pain patient for over 30 years and works part-time as her health allows. For more information about Ann Marie's counseling services, visit her website. 

New Treatment Significantly Reduces ‘Frozen Shoulder’ Pain

By Pat Anson, PNN Editor

Preliminary results from a small study show that an experimental treatment for adhesive capsulitis -- also known as “frozen shoulder” – dramatically reduces pain and quickly improves function in patients.

Frozen shoulder occurs when ligaments and connective tissues surrounding the shoulder joint become sore and inflamed. The inflammation gets so painful that many patients have difficulty using their arms. The resulting lack of use makes the shoulder joint even more stiff and inflamed – a vicious cycle that “freezes” the shoulder in place.

About 200,000 people annually in the U.S. develop frozen shoulder, mostly middle-aged adults. Several years ago, I was one of them. The pain was so bad at times, it felt like someone whacked me in the the shoulder with a baseball bat. I had trouble putting on a shirt or sleeping in the same position for more than a few hours.

Frozen shoulder is usually treated with physical therapy, massage, joint injections or pain medication, until the symptoms resolve in a few months or perhaps even years. Thankfully, that’s what happened to me. More serious cases can result in rotator cuff surgery.  

Researchers at the Vascular Institute of Virginia used a less invasive procedure called Arterial Embolization of the Shoulder (AES) to reduce blood flow into the shoulder of 16 patients with adhesive capsulitis. Physicians inserted a catheter through a pinhole-sized incision in the patients' wrists that was used to feed microscopic particles into six arteries leading into the shoulder.

"Patients with frozen shoulder are essentially told to tough it out until their symptoms improve, but considering the significant pain and decreased function many experience, we looked to determine if this treatment model of embolization, already in use in other areas of the body, could provide immediate and durable relief," said lead author Sandeep Bagla, MD, director of interventional radiology at the Vascular Institute of Virginia.

It may sound counter-intuitive, but decreasing the flow of blood into shoulder tissue significantly reduced the patients’ pain and inflammation.

"We were shocked at the profound and dramatic improvement patients experienced in pain and use of their shoulder," says Bagla. "We are early in the investigation of this treatment but are inspired by its effectiveness in reducing pain and range of motion in patients' shoulders."

The treatment was conducted on an outpatient basis and takes about one hour. Nine patients reported minor side effects such as skin discoloration.

The findings were recently presented in a research abstract during a virtual session of the Society of Interventional Radiology. The authors note that AES is still investigational and that conservative therapies for frozen shoulder should still be considered first.

Tiny Implant Could Revolutionize Stimulators

Pat Anson, PNN Editor

Engineers at Rice University have created a tiny implant – about the size of a grain of rice -- that can electrically stimulate the brain and central nervous system without using a battery or wired power supply.

The magnetically powered implant generates the same kind of high-frequency signals as much larger battery-powered stimulators used to treat chronic pain, epilepsy, Parkinson's disease and other medical conditions. It could be implanted almost anywhere in the body in a minimally invasive procedure.

Researchers demonstrated the viability of the implants by placing them beneath the skin of laboratory rodents that were fully awake and free to roam about their enclosures. The rodents preferred to be in portions of the enclosures where a magnetic field activated the stimulator, which provided a small voltage to the reward center of their brains.

"Doing that proof-of-principle demonstration is really important, because it's a huge technological leap to go from a benchtop demonstration to something that might be actually useful for treating people," said Jacob Robinson, PhD, a member of the Rice Neuroengineering Initiative and corresponding author of a study published in the journal Neuron.

"Our results suggest that using magnetoelectric materials for wireless power delivery is more than a novel idea. These materials are excellent candidates for clinical-grade, wireless bioelectronics."

The implant has a thin film of magnetoelectric material that converts magnetic energy into electricity. Lead author Amanda Singer created the film by joining together two layers of very different materials.

The first layer, a magnetostrictive foil of iron, boron, silicon and carbon, vibrates at a molecular level when it's placed in a magnetic field. The second layer, a piezoelectric crystal, converts mechanical stress directly into an electric voltage.

This method avoids the drawbacks of radio waves, ultrasound, light and other wireless methods to power stimulators, which can interfere with living tissue or produce harmful amounts of heat.

RICE UNIVERSITY

"The magnetic field generates stress in the magnetostrictive material," Singer explained. "It doesn't make the material get visibly bigger and smaller, but it generates acoustic waves and some of those are at a resonant frequency that creates a particular mode we use called an acoustic resonant mode."

Acoustic resonance in magnetostrictive materials is what causes large electrical transformers to audibly hum.

"A major piece of engineering that Amanda solved was creating the circuitry to modulate that activity at a lower frequency that the cells would respond to," Robinson said. "It's similar to the way AM radio works. You have these very high-frequency waves, but they're modulated at a low frequency that you can hear."

Tiny implants capable of modulating the brain and central nervous system could have wide-ranging implications. They could replace battery-powered implants used to treat epilepsy and reduce tremors in patients with Parkinson's disease. Neural stimulation could also be useful for treating depression, obsessive-compulsive disorders and chronic intractable pain.

Singer said creating a signal that could stimulate neurons without harming them was a challenge, as was miniaturization.

"When we first submitted this paper, we didn't have the miniature implanted version," she said. "When we got the reviews back after that first submission, the comments were like, 'OK, you say you can make it small. So, make it small.’

"So, we spent another a year or so making it small and showing that it really works. That was probably the biggest hurdle. Making small devices that worked was difficult, at first."

In all, the study took more than five years to complete, largely because Singer had to make virtually everything from scratch.

Nitrous Oxide Safe for Labor Pain, But Few Women Stick With It

By Pat Anson, PNN Editor

A new study is touting an older form of anesthesia for women going through labor pain. Researchers at the University of Colorado College of Nursing say nitrous oxide – commonly known as laughing gas – is a safe and effective option for pain relief.

Their study, published in the Journal of Midwifery & Women's Health, is based on a survey of 463 women who used nitrous oxide (N2O) during labor.

"Nitrous oxide is a useful, safe option for labor analgesia in the United States. And for some laboring mothers, that's all the pain relief they need,” said lead author Priscilla Nodine, PhD, a Certified Nurse-Midwife and Associate Professor with the University of Colorado College of Nursing.

Nitrous oxide was once widely used in American hospitals to relieve labor pain, but it fell out of favor as more Caesarean sections were performed and women opted for epidural injections and spinal blocks, known as neuraxial analgesia.

Some hospitals are now reintroducing nitrous oxide as a safer and less invasive option. The inhaled gas helps reduce anxiety and makes patients less aware of their pain, but does not eliminate it. 

While side effects from nitrous oxide were rare (8%), less than a third of the women studied stuck with it. Sixty nine percent wound up using neuraxial analgesia or opioids during labor. The reason most often cited (96%) for converting from N2O to another therapy was inadequate pain relief.

Women who had previously given birth vaginally were more likely to stick with nitrous oxide, while those who had a Cesarean section were six times more likely to use neuraxial analgesia. The odds of conversion from N2O tripled when labor was induced or augmented with oxytocin, a hormone that helps women bond with the baby and stimulates milk production.

“Understanding predictors of conversion from inhaled nitrous oxide to other forms of analgesia may assist providers in their discussions with women about pain relief options during labor," said Nodine.

The findings are similar to a 2019 study, which found that nearly 70 percent of the women who tried nitrous oxide switched to an epidural or another pain management method.  

Epidurals allow mothers to stay awake and alert throughout delivery. But they are not without risks. A poorly placed needle can damage the spine permanently, as Dawn Gonzalez learned years ago.

“The blind insertion of the epidural during birth is basically playing roulette for spinal damage. Normally birthing mothers are told the only side effect possible during epidurals is a spinal headache that lasts a few days,” said Gonzalez, who developed adhesive arachnoiditis, a chronic and disabling inflammation of her spinal nerves.  

“Every woman deserves to know that when she opts for any kind of invasive spinal anesthesia, the risks are very grave and by far much more common than anybody realizes.”

The American Society of Anesthesiologists has defended the use of epidurals, calling them “one of the most effective, safest and widely used forms of pain management for women in labor.”

Nerivio: What’s All the Buzz About?

By Mia Maysack, PNN Columnist

If you have migraines and are open to more holistic approaches to treating them, I’d like to share my experience with Nerivio. It’s the first smartphone-controlled neuromodulation device for the treatment of migraine, with or without aura. I was provided one of the devices, which is worn on the arm, at no cost by the manufacturer, Theranica Bio-Electronics.

Nerivio requires a prescription from a doctor. I was able to be seen via telemedicine through Cove for my appointment, which was convenient. A script was written for 12 treatments, which are thought to be most beneficial within the first 30 minutes of experiencing aura or the onset of pain.

Given that my head hurts 24/7/365, I was hesitant to even try Nerivio, but ultimately decided it was worthwhile due to the low risk of side effects. I've tried different types of neuromodulation devices before, without success, and went into this with an open mind and minimal expectations.

Nerivio didn't take any of my discomfort away, but it did cultivate a decent enough distraction. Despite my blaring head pain, I love loud music. I realize that could seem odd, but I figure since it hurts anyway, turn it up! Anything to switch up the frequency of this migraine that's stuck on repeat. 

I view Nerivio similarly. You have to chill out for the treatments, which are 45 minutes in length. Though it is possible to go about daily activities during treatments, I found it more comfortable not to. I'd take deep breaths and visualize the armband just like music, disrupting the head pain and transmitting restorative waves.   

Much like the beloved 12" subwoofer in Ophelia (my car), I controlled the volume, using my smartphone to dictate the intensity of Nerivio.

When it’s on, Nerivio delivers small electric impulses into the upper arm that disrupt pain signals in the brain. I first compared the feeling of neuromodulation to that of a tingle or itch, but after becoming more familiar, I'd label it as vibrational. It doesn't hurt, and the sensation is a welcome change of pace for anyone experiencing head pain 

It's important to remember there is a weak current of electricity, so fingers shouldn't be directly placed on the device when it's on, nor should it be used in any place other than your arm. 

The device costs about $100. That can be a significant amount of money, especially for those of us unable to maintain any sense of normalcy regarding employment or income. But I’ve paid out of pocket far more than that, regularly, for co-pays and uncovered treatments, not to mention pills that demanded Benjamin Franklin’s face for not even a week’s worth of treatment.   

What I appreciate about Nerivio is that it’s something I can do on my own. I altered the arms I used it on and always incorporated relaxation with my experiences to whatever extent I could.  It worked nicely in conjunction with mindfulness breaks, as well as first thing upon waking up or last thing before bed. 

IMAGES COURTESY OF THERANICA

It’s also relieving to literally be holding the “power” in the palm of my hands. If there’s a need to halt a session, there is a pause button. Although I didn’t get around to utilizing it, Nerivio also has a feature that assists in promoting guided imagery and meditation as a further enhancement.   

For each treatment, all that’s necessary is to hit the power button on the armband and ensure it has synced up to your device. Within the first few moments when starting, a questionnaire pops up on the screen asking how you’re feeling. This acts similarly to a virtual diary to track symptoms and hopefully improvement. This step isn’t necessary, although never a bad idea to monitor or check in as to where you’re at.

All in all, I’d have to say if you’re curious enough and able to, go ahead and give Nerivio a try.  I believe it could be beneficial for other migraine conditions not as complex as mine.  

I haven’t been paid or endorsed at all for this review and offer these words solely as a resource for those who are considering it.  Feel free to follow up with questions, as I’m honored to help navigate the Nerivio process with you in any way I am able.

Mia Maysack lives with chronic migraine, cluster headache and fibromyalgia. Mia is the founder of Keepin’ Our Heads Up, a Facebook advocacy and support group, and Peace & Love, a wellness and life coaching practice for the chronically ill.

‘Sound Healing’ With Crystal Singing Bowls

By Madora Pennington, PNN Columnist

It’s 6 in the evening, on day 31 of "Safer at Home" quarantine in Los Angeles.

I am logging into a Zoom call for sound healing. The invite said:

“The great sleeping prophet Edgar Cayce noted "Sound will be the medicine of the future.” Well the future is now.

Share this link with anyone you know that is experiencing physical pain in the body. In about a half an hour that pain will be substantially reduced or eliminated. This works every time.”

The invite is from Jeff Klein, who uses "Crystal Singing Bowls" to make harmonic tones and vibrations. Jeff says his "sound therapy" helps people relax, rejuvenate and feel less pain. You can watch one of his singing bowl concerts below.

I am not in pain, but I am rather stressed out. And curious. Plus, I do love sound. Why not?

I get Zoomed in.

We have trouble getting started as our host, Jackie, isn’t close enough to the microphone and there is a strong background hum. No one can hear what she is saying, various attendees’ blast into their microphones.

Eventually Jackie figures it out and welcomes us. She’s the “surrogate,” the person Jeff will be working on, while about 30 of us watch and listen.

Jackie tells us to, “Sit into energy of gratitude and allow that into our system.”

I am not a spiritual person, but I do my best.

I have newspapers opened on the side of my screen I’d rather be reading. I am a news junkie. But Jackie convinces me to close my eyes and let go for now, and just be grateful.

This probably is a good idea.

“I am grateful,” Jackie says, with authority.

She encourages us to feel our breath, feel the warmth and experience openness.

Okay then, I can do this.

In comes Jeff, a portly man in his 60’s, who does live singing bowl concerts where he lives in Colorado, although not during coronavirus lockdown.

Jeff explains how his sound concert cured a woman’s hearing deficit, and how another man with neck pain had it permanently relieved from sound healing.

I am skeptical, but Jeff is ready to address this.

Jeff says placebos work because the heart and mind connect and healing occurs. Not a theory I had heard of.

“We are here to raise consciousness and vibration,” Jeff tells us. “Physical mental and emotional healing can happen, just like that,” as he snaps his fingers.

He instructs us to sit back, close our eyes, relax and be ready to receive.

Nothing I object to yet, except for his description of placebo effect.

And the sound quality. Zoom is not the best for a sound healing demonstration, with the chronic, scratchy, feedback audio. It’s so abrasive, I have to turn my volume down.

Jeff is fun to watch as he maneuvers the bowl like a master pastry chef. Swirling the rod around the rim to make sound, also swirling the bowl over Jackie’s body. I wish I were her right now. I’ll bet that feels good. At times, Jackie twitches on the table.

But I can multitask. Peeking out from behind my Zoom screen is the world map of coronavirus outbreaks from the New York Times. There’s a relaxation killer.

Jeff gets a bigger bowl, this one of stainless steel. I haven’t seen bowls like this before. Jeff has strong arms. Jackie twitches a lot with this one.

I stop watching. I let the sound play. It’s beautiful, layers of reverberations without a melody or structure. It makes it easy to let go.

I read about the failure of hydroxychloraquine on the side of my screen. Who didn’t see that coming? Then on to other headlines:

Italy’s poorer south suffers under lockdown, and fears a second blow from the virus.

The number facing acute hunger could double this year, the World Food Program says.

A port city in Ecuador has become an epicenter of the outbreak in Latin America.

Yet, I feel relief in my head and body from listening to these bowls, even over dreadful sound quality.

I must hunt down music like this on Sonos. I do a search for “Tibetan Singing Bowl.” Oh good, a playlist exists.

Then I remember: Don’t I own a Tibetan singing bowl myself? Got it in Santa Monica years ago. Oh yes, it’s in my living room. I should bang it daily. Since it has mercury in it (or is it lead?), I don’t like to touch it. It’s made of seven metals, some toxic.

I read all the news during the Zoom sound healing: The Los Angeles Times, New York Times and Washington Post. Yet, I feel relaxed. I was not in pain, but if I had been, I think I would feel better.

Managing pandemic anxiety has been a challenge. My technique has been to cognitively challenge distorted thoughts. I question what I am thinking and if it is valid, since it’s making me uneasy. At the end of quarantine, I think I will emerge a saner human. But this bowl stuff was really relaxing and requires way less effort.

When it ends, Jeff invites us to share. I want to tell him this was much better than I thought and I might attend again, but I’m not really a joiner.

Other participants chime in. They talk about the mystical (or are they hallucinatory?) experiences they had: tingling sensations, warmth, visions of light. They sound happy and relaxed, like I feel. I didn’t have those phenomena happen, but I wasn’t really trying.

I will definitely add this music to my day. I’m convinced this will help me get through the pandemic, and it has less calories than wine.

I have to think relaxing and letting go probably would help pain, at least temporarily. This is an easy way to do it.

More soothed than I have been in weeks, I’m hungry for the chicken and dumplings a friend made for us. I’ll steam some green beans, too.

Madora Pennington writes about Ehlers-Danlos Syndrome and life after disability at LessFlexible.com. Her work has also been featured in the Los Angeles Times.

Low Dose Naltrexone Saved Me from a Lifetime of Pain

By Madora Pennington, PNN Columnist

The first place I felt a ripping pain in my body was in my feet, when I was 14 and growing fast. But that’s only because I don’t remember the severe abdominal hernias I was born with. They probably felt the same. After I screamed for the first two months of life, a surgeon repaired them. I still have the scars.

In adolescence, very soon after my feet began to fail me, I was distracted by the snapping of my kneecaps. More trouble walking. Next came the low back aching. Carrying my schoolbooks and sitting in class became unbearable.

My merry-go-round of symptoms could have driven me mad, I suppose, but I was overtaken with such debilitating fatigue, I did not have the energy for big emotional reactions. My clique of junior high friends were agony, isolation and loneliness that I was too tired to accept or reject.

Then my abdomen herniated again. That pain was drowned out by everything else, to be repaired years later when surrounding tissue got caught in it, requiring an emergency operation.

In spite of exhaustive doctor visits throughout my life, no one gave a me a name for what was wrong with me until I was 33: Ehlers-Danlos Syndrome (EDS). Ah, so that’s what the other kids had that I lacked: stable collagen. My life began to make sense.

EDS was named for the doctors who first noted it in the medical literature. If it had been assigned a descriptive name, it would be called Contortionist Syndrome.

If I had joined the circus, my job would have been freaky back bender. My spine is impressively loose and a particular source of torture. I spent the last half of my 20’s begging for a guillotine to make the pain in my neck and head stop. No one obliged. Rib dislocations have been another problem. Is this what it feels like to get stabbed in prison? I am in prison in my body, so that would be consistent.

Before you feel too sorry for me, or recoil in horror that a human could be born so flimsy, note that my story has a happy ending. By the end of my 30’s, I got experimental treatment that made my body produce better collagen, strong enough to end my life of disability and begin a new one, functioning in the world.

Pain Changes the Brain

It was one thing to have a more stable body, but I still had a problem. Pain creates a disease state of its own. I had been in chronic pain for about 25 years.

Pain signals danger to the body: Do something because you are getting hurt! But what happens when the pain never stops or cannot be adequately relieved? The more a brain experiences pain, the better it gets at experiencing it. That is how brains are. They get good at what they practice.

Ongoing, unrelieved pain causes a downward spiral of maladaptive changes. Chronic pain triggers fatigue and depression. Sufferers tend to avoid activity, often quite legitimately, out of fear of injury or pain aggravation. Chronic pain also seems to induce troublesome changes in learning, memory, and body perception that are similar to emotional disorders. As pain changes the brain, sufferers are likely to feel less motivated and become less able to initiate or complete goals.

These brain changes are real. Researchers have noted widespread abnormalities in the brain, such as “grey matter density, in the connectivity of the white matter, as well as in glutamate, opioid and dopamine neurotransmission.”

How Naltrexone Works

One promising treatment for disrupting and rehabilitating the vicious cycle of chronic pain is an off-label use of an old drug: Naltrexone. Naltrexone treats opioid addiction by blocking the opioid receptors so drugs like heroin cannot take effect.

However, given at much smaller doses, naltrexone blocks the opioid receptors only slightly. This creates a stimulating, re-regulating effect The result: relief and even healing. Even better news, naltrexone is one of the safest drugs around.

How does low dose naltrexone (LDN) have such a profound effect? Opioid receptors are not just in the brain, they are spread throughout the body in the guts, blood, joints, skin and nerves. The hypothalamus and adrenal glands produce hormones with opioid-like effects, creating a complex hormonal feedback system that governs everything from immunity, pleasure and pain, to how connected we feel to others. Naltrexone in low doses gently interrupts these inter-body communications, which can cause a cascade of healing.

Dr. Linda Bluestein is a pain doctor at Wisconsin Integrative Pain Specialists and host of the Bendy Bodies podcast. She often prescribes low dose naltrexone for her chronic pain patients.

“LDN acts on microglial cells and is a novel CNS anti-inflammatory agent,” says Dr. Bluestein, adding that LDN works well not only on persistent pain (fibromyalgia, complex regional pain syndrome, migraine, irritable bowel syndrome, etc.), but also for autoimmune diseases, inflammatory conditions, neuropathic pain, chronic fatigue syndrome and myalgic encephalomyelitis.

“Results are very positive. Many patients get outstanding pain relief. The remainder get moderate pain relief,” said Bluestein. “Some don't really observe much pain relief but want to continue taking the medication because the incidence of infections is lowered. This is because naltrexone given in low doses (1.5 to 4.5 mg) can act as an immunomodulator benefiting both autoimmune diseases and immune function.”

As for side-effects, Dr. Bluestein notes that a patient must be off opioids to take LDN.

“The most common side-effect is vivid dreams. Occasionally a patient will have GI issues, abdominal pain, or even more rarely, loose stools. Cost is sometimes a barrier as insurance rarely covers LDN. Access is another occasional barrier as it must be obtained from a compounding pharmacy,” she explained.

Back to my story, my life of pain interrupted. I have been taking low dose naltrexone for years now. In spite of healthier connective tissue, pain had ravaged me. LDN went far to undo that. Results took time, but were well worth the wait. I would say LDN gave me my personality back, which chronic pain (and also long-term opioids) had altered.

As someone with Ehlers-Danlos, my body is overly-sensitive and overly-perceptive. Activity that is moderate, normal, and completely safe can cause alarm bells of injury and trauma to my brain, even though I am not actually injured.

Why this happens with EDS is not understood, but in my experience, LDN keeps this phenomena from becoming a downward spiral of more pain, depression, fatigue and dysfunction.

Madora Pennington writes about Ehlers-Danlos and life after disability at LessFlexible.com. Her work has also been featured in the Los Angeles Times.

The Pros and Cons of Telehealth

By Barby Ingle, PNN Columnist

The coronavirus lockdown has many providers now offering telehealth or telemedicine – ways to connect with a doctor without actually seeing them in person. Telemonitoring and concierge medicine are also becoming more popular.

The tele-words are often used interchangeably, but they have different meanings. How do you use them? What are the pros and cons?

Telehealth is the distribution of health-related services and information, usually over the phone or online. It allows long-distance patient and clinician contact, care, advice, reminders, education, intervention, monitoring and remote admissions.

Telemedicine is the practice of medicine using technology to deliver care at a distance. A physician in one location uses telecommunication to deliver care to a patient at a distant site.

Telemonitoring refers to the transmission of health data, such as heart rate, blood pressure, oxygen saturation, and weight directly to providers by phone, online or some other electronic means.

Concierge medicine is a relationship between a patient and a primary care physician in which the patient pays an annual fee or retainer. Be sure to check with your insurance to see if they cover concierge medicine or it can be pricey.

Ken (my husband and caretaker) and I have been using telehealth and concierge medicine for more than 5 years. We didn’t choose concierge medicine, but when our primary doctor decided to go that route, we looked into it heavily and made a decision to stay with him.

Our doctor joined MDVIP, a national network of primary care physicians who treat fewer patients and focus on personalized medicine. We can visit him in his office or by phone, text, email and video calls. He offers a wide range of preventive care that is covered in his fees.  And because he works in a network with other providers around the country, if we are traveling and have an emergency, we can see another doctor and it is covered.

Studies published in peer-reviewed medical journals show patients in concierge medical practices receive more preventive services and enjoy better control of chronic conditions than patients in traditional practices. Other studies show concierge patients are hospitalized and readmitted less often, and visit urgent care and emergency rooms less often.

I love having a true partner on my health team.  When you can’t leave home, you can still get that one-on-one service with a provider.  Transportation issues, taking time off from work, and finding child care are no longer an issue for routine visits and follow-up care. Yet, we still have the option for in-person visits when lab tests and other diagnostic tools are needed.

Providers who use telehealth can benefit from the streamlined reimbursements, improved patient satisfaction and retention, reduced no shows and cancellations, and boost the efficiency of their staff and themselves. Providers who use telehealth are also exposed to less virus and bacterial spreading — so its an important safety measure for them, as well as patients.

There can be a few drawbacks to telehealth. If you are not a “tech person,” your first few video calls can be an issue. A recent visit I had with a doctor by video was harder for him than me since I was only his second video appointment ever. For telehealth to work, the patient and provider need to have good internet connections, and some remote places in the U.S. still don’t have that.

If you are using telemedicine services that are not always with the same care team, you could also get a reduction in care quality. What might stand out to your longtime doctor or nurse may not be significant to a provider who doesn’t know your medical history. There is also a lack of personal touch.

Telemedicine is more for cases that don’t require a physical exam.  Telemonitoring is beneficial for chronic patients and the elderly. Concierge medicine is a great combination of telemonitoring, telemedicine and keeping the relationship strong between the patient and provider.

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.  

Can Vitamin C Treat COVID-19?

By Madora Pennington, PNN Columnist

Viral infections like COVID-19 are difficult to treat. Unless and until a targeted anti-viral drug or vaccine is developed, symptomatic support is what is given to patients to ease suffering and prolong life -- until their own body hopefully defeats the coronavirus.

While most coronavirus infections are mild or even lack symptoms, to vulnerable patients they can be devastating. The virus can infect various organs, including the brain, lungs and nervous system, which leads to a cascading response of damaging inflammation. Patients can die from respiratory failure or septic shock, ironically caused by an over-reaction of their own immune system battling the virus.

One adjunctive therapy that emerged from the desperation to save patients in Wuhan, China is intravenous ascorbic acid. Yes, that is Vitamin C. A placebo-controlled study has begun in Wuhan to determine if Vitamin C infusions are helpful in treating 140 patients with coronavirus pneumonia. A similar clinical study is underway in Italy.

Doctors in New York are currently administering Vitamin C intravenously to coronavirus patients in large doses that are well above the recommended daily dose.

"I have to hope that this, or any new idea, may help," Peter McCaffery, Professor of Biochemistry at the University of Aberdeen in the UK, told Newsweek.  

"Just to reiterate though, taking large doses of Vitamin C tablets would be very unlikely to protect you from COVID-19 -- unless you were actually Vitamin C deficient, which with a normal diet is quite rare."

McCaffery says Vitamin C is relatively safe because, unlike many other vitamins, it does not build up to toxic levels. The worst side-effect is a potential kidney stone. Large amounts of C taken orally can also upset the stomach.

Previous studies have found that Vitamin C can help prevent death from the deadly complication of sepsis. Scientists believe Vitamin C stops the surge of immune cells that lead to lung destruction and helps reduce fluid buildup in the lungs. Vitamin C helps modulate the immune system, meaning it helps the immune system function properly, not over-reacting and not under-reacting. It also has antiviral properties.

Important for Overall Health

Vitamin C is critical for the maintenance of body functions and normal physiology. It helps the body maintain homeostasis -- the constant adjustments the body makes to keep conditions stable. For example, when a person eats and experiences a rise in glucose, insulin is produced to bring sugar levels down to normal. A breakdown in the body’s ability to maintain homeostasis is what leads to diabetes.

Vitamin C is essential for the formation of collagen, which is everywhere in the human body, gluing everything together. It is necessary for wound healing.

Vitamin C also supports the development of neurons and plays a role in learning and memory. Studies have shown that people with higher concentrations of Vitamin C are more cognitively intact compared to cognitively impaired individuals.

Some studies have shown Vitamin C can shorten the length of a cold, prevent it entirely under certain circumstances, and also reduce flu symptoms. But more research is needed in this area because findings have been mixed. Scientists suspect inconsistent results may be due to the variability of an individual’s ability to absorb Vitamin C and handle oxidative stress.

Some people need more Vitamin C than others to achieve healthy levels of ascorbic acid. Oxidative processes are especially altered in patients with obesity, cancer, neurodegenerative diseases, hypertension and autoimmune diseases. Lower concentrations of Vitamin C are also found in patients with metabolic syndrome.

Nearly all mammals manufacture their own Vitamin C when they are ill or injured. But chimpanzees and humans have a broken copy of the C manufacturing gene. We must obtain ours from food.

During the Age of Sail, a disease of profound Vitamin C deficiency — scurvy — killed an estimated 2 million sailors. At the time, no one knew Vitamin C was such a vital nutrient. Ships set sail on long voyages without enough food that contained it.

Scurvy was a terrible disease and a terrible way to die. Initially overcome with severe fatigue and weakness, sailors became unable to think or work. This created suspicion that laziness itself caused this mysterious disease.

As the body became more and more depleted of Vitamin C, healed fractures re-broke. Old wounds reopened and bled. Bruises formed at the slightest touch. Gums bled and teeth fell out. Joints ached. Flesh turned black and gangrenous. Fatal aortic ruptures or brain bleeding came on suddenly. Scurvy this severe is rarely seen in the modern world.

My interest in Vitamin C is very personal. I have an inherited collagen disorder called Ehlers-Danlos Syndrome (EDS), a poorly understood disease. Vitamin C loading is recommended for my condition, as many of my symptoms are similar to scurvy.

My doctor and I discovered I benefit exponentially from injecting Vitamin C, rather than taking it orally. Why is a mystery. For those interested in oral supplementation, liposomal C is the best choice.

Madora Pennington writes about Ehlers-Danlos and life after disability at LessFlexible.com. Her work has also been featured in the Los Angeles Times.

Study Finds ‘Good Evidence’ Acupuncture Can Treat Migraine

By Pat Anson, PNN Editor

Recent advances in treating and preventing migraines with new drugs have created a “treatment revolution” in migraine therapy.  But a more ancient technique may work even better, according to a small study recently published in the British Medical Journal (BMJ).  

Researchers in China say acupuncture was up to four times more effective than a non-steroidal anti-inflammatory drug (NSAID) in reducing attacks of episodic migraine without aura.

The study involved 147 migraine patients treated at seven hospitals in China from 2016 to 2018. The patients were divided into three groups; with one group getting 20 sessions of manual acupuncture, another group getting sham (fake) acupuncture, and the third group getting “usual care” that included use of the NSAID diclofenac.  

By the end of the study, patients who received acupuncture were having 2.3 fewer migraine attacks a month, compared to 0.4 and 1.6 fewer attacks for the usual care and sham groups, respectively. 

“In this study in acupuncture naive patients with episodic migraine without aura, 20 sessions of manual acupuncture produced a relatively long lasting reduction in migraine days and migraine attacks compared with sham acupuncture and usual care,” researchers reported. “Overall, the therapeutic effects in the manual acupuncture group occurred earlier, were larger, and might last longer.”

‘Useful Additional Tool’

According to one migraine expert, the study shows that acupuncture can be a “useful additional tool” in migraine therapy.

"We now have good evidence that acupuncture is an effective treatment for episodic migraine," writes Heather Angus-Leppan, MD, a neurologist at the Royal Free London NHS Foundation Trust, in a BMJ editorial. "(The study) helps to move acupuncture from having an unproven status in complementary medicine to an acceptable evidence-based treatment."

The study drew a mixed reaction from readers in The Daily Mail.

“Great if it works for you, but it did absolutely nothing for me except wasted money I could Ill afford,” one poster wrote.

“Unfortunately, never worked for me. But good for those who it did. Migraines are a debilitating thing to have,” said another.

“I suffered weekly migraines for decades before trying acupuncture, given by a lady who trained for years in China. After the first session the migraines stopped completely for around 20 years. When they recurred, I tried acupuncture again, from the same lady, and it had no effect at all. I'd still say it's really worth giving it a go,” wrote another poster.

“I had severe and frequent migraines as a teenager - the doctors tried everything from beta blockers to a dairy free diet. Acupuncture was the only thing that really worked - it broke the cycle and my migraines became less severe and more infrequent,” another poster said. “Now I rarely have a migraine at all and if I get a headache using pressure points really helps. It worked for me but may not work for everyone.”

Migraine affects about a billion people worldwide and 36 million adults in the United States, according to the American Migraine Foundation. In addition to headache pain, migraine can also cause nausea, vomiting, blurriness or visual disturbances, and sensitivity to light and sound.

As many as 3 million Americans receive acupuncture treatments, most often for relief of chronic pain. While there is little consensus in the medical community about the effectiveness of acupuncture, the Centers for Medicare & Medicaid Services (CMS) recently said it would start covering acupuncture for Medicare patients with chronic low back pain.