Pilot Study Finds Green Light Therapy Improves Fibromyalgia Symptoms

By Pat Anson, PNN Editor

Fibromyalgia patients exposed to green light therapy had significant improvements in their pain, sleep and quality of life, according to a new pilot study published in the journal Pain Medicine.

The small clinical trial by researchers at the University of Arizona is the first to explore the benefits of green light in treating fibromyalgia symptoms. Previous studies have focused on green light therapy as a treatment for migraine headaches. Green light is believed to have a calming effect on the brain and causes less eye strain.  

Twenty-one adult patients with fibromyalgia being treated at the university’s chronic pain clinic were enrolled in the study. They were exposed to green light-emitting diodes (GLED) for one to two hours daily for 10 weeks. While undergoing treatment, patients were asked to avoid all other sources of light, including computers, smartphones and television, but encouraged to engage in other activities such as reading and listening to music, and to avoid falling asleep.

“To our knowledge, this one-way crossover design efficacy-study clinical trial is the first description of a successful implementation of GLED exposure as a therapy to manage fibromyalgia pain without any reported side effects. The patients enrolled in this study reported significant reduction in their overall average pain intensity, frequency, and duration after GLED treatment,” wrote lead author Mohab Ibrahim, MD, an associate professor in the Departments of Anesthesiology and Pharmacology at UArizona College of Medicine-Tucson. 

In addition to less pain, patients also reported better mood and sleep, and improvements in their ability to work, exercise and perform chores. Eleven patients said they also reduced their use of pain medication, including opioids, while being exposed to green light.    

“GLED may be a safe and affordable method to manage fibromyalgia. We did not observe side effects in animal studies or in reports from our patients. The observed safety and efficacy, coupled with the simplicity of this method, merit further investigation and the design of a randomized clinical trial to fully investigate the role of GLED for fibromyalgia and possibly other chronic pain conditions,” researchers concluded. 

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep and depression. Many patients report conventional treatments for fibromyalgia are ineffective or have unwelcome side effects. 

In an email to PNN, Ibrahim said he was conducting two more studies on the use of green light to treat other pain conditions, but was not ready to release his findings. He recently reported the results of a small study of green light as a preventative therapy for migraine. 

“Should anyone use green light products? The risk is low, but I still suggest people speak with their physicians first before attempting any therapy,” Ibrahim said.    

Light Sensitivity 

Although more research is needed to fully understand how green light therapy works, some commercial products are available to the public without a prescription.

One is a portable green light lamp made by Allay, a company founded by Harvard Medical School Professor Rami Burstein, PhD, who was the first researcher to discover that different colors in the light spectrum can affect light sensitivity – known as photophobia – among migraine sufferers.

Burstein learned that blue light (the light emitted by TVs and computer screens) can trigger migraines, while a narrow band of green light at low intensity can reduce the severity of migraine attacks.

“Green light has a calming effect because it reduces electrical activity (in the brain),” Burstein told PNN. “It is the only color of light that is associated with positive emotion and reducing anxiety. All other colors of light increase anxiety, irritability, being afraid, being scared, being angry, a whole host of negative emotions.”

Burstein and his partners asked lighting experts to design an affordable green light lamp that people can use at home. Initial estimates ran in the thousands of dollars, but they have since managed to reduce the cost to $150.

ALLAY IMAGE

“It is safe. It’s not invasive. It is inexpensive,” Burstein says. “Try it. Give it a month or two. If it doesn’t work, you can return it for free. No questions asked.”

Allay began selling the lamps in January with a money back guarantee. Of the 3,000 lamps sold so far, Burstein says less than 4 percent of customers have asked for their money back. He expects an updated version of the lamp to be available by the end of the year for less than $100.

Burstein says the lamp eliminates photophobia in nearly all migraine patients. He recommends that migraine sufferers use the Allay lamp one to two hours every day to reduce the frequency and severity of headaches.

Study Shows Cannabis Oil Improves Fibromyalgia Symptoms

By Pat Anson, PNN Editor

A small placebo-controlled trial shows that daily doses of cannabis oil rich in THC (tetrahydrocannabinol) significantly improves pain, fatigue and quality of life in people with fibromyalgia.

The study findings, recently published in the journal Pain Medicine, involved 17 women with fibromyalgia living in Florianopolis, Brazil. Participants were given drops of cannabis oil or a placebo for eight weeks, starting with an initial dose of one drop a day orally and then titrating to an average of 3-4 drops a day.

The cannabis oil used in the study contained 1.22 mg of THC and 0.02 mg of CBD (cannabidiol) per drop. THC is the psychoactive ingredient in marijuana.

The women self-reported their symptoms on a questionnaire every 10 days. Few changes were noted in the placebo group, but the women receiving cannabis oil reported significant improvement on a wide range of symptoms, including pain, depression, anxiety and fatigue. They were also more likely to “feel good” and not miss work compared to the placebo group.

“To our knowledge, this is the first randomized controlled trial to demonstrate the benefit of cannabis oil -- a THC-rich whole plant extract -- on symptoms and on quality of life of people with fibromyalgia,” researchers said. “During the intervention, the impact of the intervention on quality of life in the cannabis group participants was evident, resulting in reports of well-being and more energy for activities of daily living. Pain attacks were also reduced, albeit subjectively, in frequency and intensity.”

The researchers concluded that cannabinoids can be a low-cost and well-tolerated therapy for fibromyalgia patients, and recommended that it be included as an herbal medicine option in Brazil’s public health system.

“The demonstration of safety and efficacy in this gold-standard model is significant. Millions of Americans suffer with FM (fibromyalgia) – a condition that tends to be poorly controlled by standard medicines. These clinical findings indicate that for many of these patients, plant-derived cannabis preparations may be a safe and effective alternative,” said Paul Armentano, Deputy Director of NORML, a pro-marijuana advocacy group.

A major weakness of the Brazilian study is its small size. Participants also continued to self-medicate with analgesics and anti-inflammatory medications during the study, which could have affected the findings.

A larger 2019 study in Israel also found that cannabis reduces pain and improves quality of life for fibromyalgia patients. The cannabis used in that study was ingested by tincture, oil or vaporizer.

Study Finds ‘Evidence Lacking’ for Most Fibromyalgia Treatments

By Pat Anson, PNN Editor

A new analysis has found little evidence to support the long-term use of any medication or therapy to treat fibromyalgia, a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep and depression.

An international team of researchers from Brazil and Australia reviewed 224 clinical trials of fibromyalgia treatments and found many of them small and of poor quality. High quality evidence was found for cognitive behavioral therapy (CBT), anti-depressants, and central nervous system (CNS) depressants as short and medium-term treatments for fibromyalgia. No treatment was found to be effective long term.

“In this systematic review, the effectiveness of most therapies for fibromyalgia was not supported. Strong evidence supported only cognitive behavioral therapy for pain, as well as antidepressants and central nervous system depressants for pain and quality of life, but these associations were small,” wrote lead author Vinícius Cunha Oliveira, PhD, an adjunct professor at Federal University of the Valleys of Jequitinhonha and Mucuri in Brazil.

“Some therapies may be associated with small reductions in pain and improvements in quality of life in people with fibromyalgia; however, current evidence is lacking for most therapies.”

The study findings, published in JAMA Internal Medicine, reflect what many fibromyalgia sufferers already know; many treatments are ineffective in improving their symptoms.

The Food and Drug Administration has approved only three drugs for fibromyalgia; the antidepressants duloxetine (Cymbalta) and milnacipran (Savella), and the anti-seizure medication pregabalin (Lyrica). All three drugs were originally developed for other medical conditions and are being repurposed as treatments for fibromyalgia.

A large 2014 survey of fibromyalgia patients by the National Pain Foundation found that most people who tried the three FDA-approved drugs did not feel they were effective.

Exercise, acupuncture, massage, electrotherapy, myofascial release, and several other non-pharmaceutical treatments are also commonly recommended for fibromyalgia pain. Researchers found only “moderate” evidence to support their short-term use. High quality evidence was only found for CBT, a form of meditation in which a therapist works with a patient to reduce unhelpful thinking and behavior.

“Clinicians should be aware that current evidence for most of the available therapies for the management of fibromyalgia is limited to small trials of low methodological quality,” researchers concluded. “Clinicians and patients should choose therapies by considering other important outcomes in addition to those presented in this review, such as adverse effects, out-of-pocket costs, and patient preferences.”

The National Institutes of Health estimates about 5 million Americans have fibromyalgia. Most people diagnosed with fibromyalgia are women, although men and children also can be affected.

FDA Designates First Virtual Reality Device for Chronic Pain

By Pat Anson, PNN Editor

AppliedVR, a Los Angeles-based virtual reality company, has announced that its EaseVRx headset has received Breakthrough Device Designation from the Food and Drug Administration for treating fibromyalgia and chronic intractable low back pain.

EaseVRx is the first virtual reality (VR) device to get a Breakthrough Designation from the FDA for treating a chronic pain condition. The designation speeds up the development and review of new medical devices that treat life-threatening or irreversibly debilitating diseases or conditions. It could also speed up insurance coverage of VR therapy for chronic pain.

“AppliedVR is the most evidence-backed VR platform on the market, and today’s FDA designation demonstrates that health experts across the spectrum recognize the therapeutic potential of VR as a viable treatment for pain,” Matthew Stoudt, CEO and co-founder of AppliedVR, said in a statement.

“Now, with the COVID-19 pandemic severely disrupting Americans’ ability to get in-person care safely, we’re looking forward to getting EaseVRx into the hands of people suffering from pain. Providers believe in it, patients want it, and payers are coming around to it.” 

AppliedVR funded a recent clinical trial that showed VR therapy can be self-administered at home to treat chronic pain. Patients living with fibromyalgia or chronic lower back pain were given VR headsets and instructed to watch at least one virtual reality program daily for 21 days.

The programs immerse users in a “virtual” environment where they can swim with dolphins, play games or enjoy beautiful scenery. The goal is to help patients learn how to manage their pain and other symptoms by distracting them and making their pain seem less important

At the end of the study, 84 percent of the patients reported they were satisfied with VR therapy. Their pain intensity was reduced an average of 30 percent. Physical activity, mood, sleep and stress levels also improved.

“Virtual reality is a promising skills-based behavioral medicine that has been shown to have high patient engagement and satisfaction,” said Beth Darnall, PhD, AppliedVR’s chief science advisor. “However, chronic pain patients to date have had very limited access to it, so we’re excited to continue working with the FDA to develop our platform and get it into the market faster.”

PNN columnist Madora Pennington, who lives with chronic pain from Ehlers-Danlos Syndrome, recently reviewed one of AppliedVR’s headsets. She said watching VR programs helped calm and relax her.

“The benefits of VR therapy continued for me after the sessions ended. When pain or panic about pain began to set in, I found it drifts away rather than latching onto me like it used to,” Madora wrote. “After a couple weeks of VR, during a visit to physical therapist, I noticed I was no longer afraid of her touching my neck and back, and actually enjoyed it.”

AppliedVR’s technology is being used in hundreds of hospitals, but is not expected to be available for home use until next year. The company is working with Geisinger Health and Cleveland Clinic on two studies to see if VR therapy can be used as an opioid-sparing tool for acute and chronic pain.

VR for Phantom Limb Pain

Virtual reality technology received another boost this week when the Department of Defense awarded Chicago-based Coapt a $2.3 million grant to develop virtual reality therapies for phantom limb pain. Wounded veterans and amputees who have lost arms or legs often suffer from nerve pain and other sensations from their missing limbs.

"Phantom limb pain is a serious and persistent challenge for many upper and lower-limb amputees, and new, technology-based therapies have incredible promise," Blair Lock, co-founder and CEO of Coapt, said in a statement. "Preliminary work has shown that VR-based, actuated therapy can manage pain more effectively and have lasting effects. This grant will allow us to further study this therapy and bring to market a solution for those suffering from phantom limb pain in a way that also happens to be engaging."

Coapt has previously developed a VR-based therapy to help upper-limb amputees improve control of their prostheses. The technology also shows promise as a treatment for phantom limb pain. Coapt will use the grant money to further study the effectiveness of VR therapy and create a commercially viable product for both civilians and veterans with upper and lower-limb amputations.

COVID-19 Lockdown Made Symptoms Worse for Pain Patients

By Pat Anson, PNN Editor

A new survey is providing some insight into how patients suffering from arthritis, fibromyalgia and other types of joint and muscle pain fared during the early stages of the coronavirus pandemic.

In late April, researchers at the University of East Anglia (UEA) surveyed 678 patients in the UK with musculoskeletal pain, asking how the pandemic impacted their well-being and access to healthcare. The online survey was conducted five weeks after the start of a nationwide lockdown in which at-risk patients were told to “shield” at home, avoid all social contact, and postpone or cancel non-urgent healthcare appointments.  

"When lockdown happened, we were worried that this may become a much greater problem - particularly for those with bone, joint and muscle pain,” said co-author Toby Smith, PhD, a professor at UEA's School of Health Sciences. “We wanted to know how the new restrictions might affect pain, and better understand who is most at risk of experiencing flare-ups, or reduced well-being due to social isolation and loneliness.

"Our results show that the coronavirus pandemic is a major challenge to people's health and well-being, both to young and older people.”

Over half the patients (53%) reported that their musculoskeletal symptoms had worsened since the start of lockdown. About a third said they had seen a general practitioner or hospital rheumatologist because their pain, stiffness and overall health had significantly worsened. Those who reported greater social isolation and loneliness were less likely to access healthcare.

The vast majority of respondents, over 88 percent, reported little difficulty getting medication during the lockdown, but nearly half (44%) needed the assistance of others to do it.

"Should further isolation measures need to be enforced as we have seen in some part of the UK as the pandemic continues, particular efforts should be made to protect and support the socially isolated as a vulnerable group,” said co-author Alex MacGregor, PhD, a professor at UEA's Norwich Medical School. "Healthcare providers should reach out to individual patients who do not come forward for advice, and who might be silently struggling with their disease.”

Due to a recent surge in coronavirus infections, British Prime Minister Boris Johnson recently tightened nationwide restrictions, ordering bars and restaurants to close by 10pm. More people are also being required to wear masks. Asked about reports the government was planning a “total social lockdown” in northern England and London, Johnson’s health minister told the BBC she wouldn’t rule it out.

The UK survey findings, published in the journal Rheumatology: Advances in Practice, are similar to those found in a PNN survey of over 2,200 patients in April. About 70% said they were worried about going to a hospital or doctor’s office and had postponed or cancelled a medical appointment. A little over half said social isolation made them feel lonely.

Quell Customers to Receive $3.9 Million in Refunds

By Pat Anson, PNN Editor

The U.S. Federal Trade Commission is sending refunds of nearly $3.9 million to consumers who bought Quell, a wearable nerve stimulation device touted as a drug-free treatment for chronic pain. The refunds are part of a settlement the FTC reached in March with NeuroMetrix – the maker of Quell – over deceptive advertising.

An FTC complaint alleged that NeuroMetrix and CEO Shai Gozani advertised Quell as an effective treatment for fibromyalgia, osteoarthritis, sciatica, shingles and other chronic pain conditions without reliable scientific evidence to back it up.  

Two clinical studies cited in Quell advertisements had “substantial flaws,” according to the FTC, while a third study was based on a marketing survey conducted by the company to “generate potential advertising claims” about the device. The FTC also objected to claims that Quell was “clinically proven” and “FDA cleared” for chronic pain relief.

“Defendants engaged in their unlawful acts and practices repeatedly over a period of more than four years, continued their unlawful acts or practices despite knowledge of complaints that advertising claims for Quell were not substantiated and went beyond claims the FDA allowed for similar devices, and continued such deceptive advertising unabated until FTC staff notified them it would recommend law enforcement action,” the FTC complaint said.

Neurometrix settled the case – without admitting or denying the allegations – for $4 million. The company also agreed to stop claiming that Quell provides relief for chronic or severe pain beyond the knee area where the device is worn.

The FTC is using the settlement funds to send 2,144 refund checks and 67,998 refunds via PayPal to Quell purchasers. The average refund amount is $55.10 per customer. Consumers who do not receive a refund, but believe they should, should contact the refund administrator, Rust Consulting, at 1-866-403-6545.

The Quell device sells for $299, while an older version is available for $199. Quell is sold over-the-counter, does not require a prescription and is not usually covered by insurance.

NeuroMetrix recently announced that Quell will be used in a clinical trial on the use of transcutaneous electrical nerve stimulation (TENS) for chemotherapy-induced peripheral neuropathy  The study is being conducted at the University of Rochester School of Medicine and Dentistry, with funding from the National Institutes of Health. Quell is also being evaluated in a small study as a treatment for fibromyalgia.

Therapy Dogs Give Relief to Fibromyalgia Patients

By Pat Anson, PNN Editor

It’s well-known that having a pet or support animal can provide significant psychological benefits to people suffering from stress, anxiety or loneliness. A new study at the Mayo Clinic suggests that pet therapy can also help people with fibromyalgia.

To gain a better understanding of the physiological and emotional benefits of pet therapy, researchers monitored the hormones, heart rate, temperature and pain levels of 221 patients enrolled in the Mayo Clinic Fibromyalgia Treatment Program. Half of the participants spent 20 minutes interacting with a therapy dog and its handler, while the other half served as a control group, spending the same amount of time with the handler only.

The research findings, recently published in Mayo Clinic Proceedings, are striking. People who interacted with a therapy dog had a statistically significant increase in levels of salivary oxytocin – a hormone released by the pituitary gland that is known as the “cuddle hormone” or “love hormone.”

They were also more relaxed, their heart rates decreased, and they reported more positive feelings and fewer negative ones compared to the control group. Over 80% agreed or strongly agreed that animal therapy was helpful to them.  

Pain levels declined in both groups, but there was a larger decrease in those who interacted with the therapy dogs. On average, severe pain scores in that group dropped to more moderate levels.

“Given that individuals with FM (fibromyalgia) suffer pain chronically, this reduction, even if numerically minimal, could help to provide symptomatic relief and quality of life improvement,” researchers concluded. “Overall, the study showed that a 20-minute human-animal interaction (treatment group) as well as a human-human interaction (control group) could improve the emotional and physiological state of patients with FM; however, those who interacted with a therapy dog showed a more robust improvement.”

Fibromyalgia is a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep, anxiety and depression. Its cause is unknown and many treatments prove ineffective. 

Therapy Dogs Calmer

The Mayo Clinic study was unique in another way – because researchers monitored and collected saliva from the dogs to see how they responded to the therapy sessions. Although therapy dogs are used in a wide variety of clinical settings, little is known about the impact of therapy sessions on the emotional state of the dogs.

Researchers say the 19 dogs involved in the fibromyalgia study -- all members of the Mayo Clinic Caring Canines program – did not show signs of stress, appeared to be more relaxed, and had significantly lower heart rates at the end of the sessions, a sign that they enjoyed interacting with patients.

"We need to expand our understanding of how animal-assisted activity impacts therapy dog's well-being, and this sizeable study with 19 dogs of various breeds provided solid evidence that animal-assisted activity done in the right condition does not have negative impacts on well-trained therapy dogs," said François Martin, PhD, a researcher for Purina, which sponsored the study.

"This only encourages us to do more research to continue to demonstrate the power of the human-animal bond on people while ensuring assistance animals also experience positive wellness as a result of their work."

You don’t need a trained therapy dog to enjoy the benefits of having a pet. A recent survey of older adults found that dogs, cats and other pets help their owners enjoy life, reduce stress, keep them physically active, and take their minds off pain.

My Name Is Fibromyalgia

By Cathy Kean, Guest Columnist

I am an unwelcome, uninvited, germinating presence that has come to invade your peaceful existence. You will never be the same. I will fill you with misery and take over every aspect of your life. My name is fibromyalgia.

When I am feeling especially mischievous, I will cause you aches and extreme pain. I will rob you of your strength, energy and cognition. You will try to formulate a complete sentence, but only to be able to grasp a few basic words. This is called fibro fog.

I will make it difficult for you to concentrate on anything and your memory will suffer drastically! You will be told constantly by others, “Don’t you remember I told you?” They’ll be thinking you are intentionally trying to get out of something.

I see your frustration and I see your sorrow. Once you were an outgoing, social and engaging individual. Now you are pretty much a recluse. See? I am good at what I do.

You think you can get rid of me by going from doctor to doctor? Silly one, you have been to 8 doctors already and they all discount you by saying, “There is nothing wrong. It’s all in your head.”

Wreaking havoc is what I do best. I will rob you of sleep and much more. I’ll make your body temperature go crazy hot when it’s cold, and cold when it’s hot. You will never feel comfortable again.

I’ll give you digestive issues, anxiety and depression. You will experience lack of control, grief, worry, immune dysfunction, chest pain, panic attacks, inflammation, insomnia and memory loss. Your body will be overly sensitive to pretty much everything, thanks to me!

I will introduce a new sensation into your existence called “noxious stimuli.” It could be a bad smell, bright light, noise, anything. Because your body is now overly sensitive, it will react strongly to just about anything. The lights will be too bright when they’re just fine for everyone else. The same goes for visual chaos, heat, cold and pressure on your skin.

Your nerves will overreact to the things around you and your brain will get overloaded when it gets these signals that intensify your pain.

I will attack you when you least expect it. You will have no way of knowing when, because I am always present, always lurking around! This will hurt your family, your career, your outlook and your sense of self. I will follow you everywhere, never a reprieve!

When I am angry, your days will be hell and your nights sleepless. I’ll be behind you, beside you, everywhere, every day. To the point where you will not remember a time when you lived outside of my grasp.

Imagine feeling like you were burning from the inside out. The stress will be huge and will exacerbate all your other conditions! Your bones will feel like someone is using a jackhammer on them, especially during a change of weather.

Emotionally, I will make it so anything, even something little, will stress and worry you, which will make your body rebel and symptoms flare up just for the fun of it. Your nerves will create phantom itches that will make you scratch yourself raw. The simplest tasks will take you 10 times longer and five times as much energy to finish.

Because I am an invisible illness, others will not be able to see your pain, suffering and degree of sickness. You will hear comments such as:

• “But you don’t look sick.”

• “Must be nice to sit in bed all day.”

• “Your pain can’t be that bad.”

• “If you ate better, you’d feel better.”

You will be called lazy, a liar, faker, fabricator and more.

Because I make you hurt so much, you will need pain relief. The most effective and efficient medication for your symptoms will be prescription opiates. But they have been stigmatized and demonized by doctors, family, government and more. You will be called a drug seeker, an addict, and a druggie. So many hurtful, demeaning labels will be placed upon you which will hurt, damage and wound your soul.

Why? You didn’t ask for this!

It’s because of ignorance! The media has inundated the public by selling them a sensationalized, false and inaccurate narrative about opioids to sell papers and get ratings. Judgmental people who jump to conclusions without researching the true answers.

Shame on them for their cruelty. They make my job so easy, which is to inflict pain, suffering and mayhem.

So here I am, fibromyalgia, your new friend. I am always looking for others to invade and conquer. Unless you’ve walked in the shoes of others who are afflicted, you will never know the depth of their struggles.

Cathy Kean lives in California. She is a grandmother of 7 and mother of 4. Cathy has lived with intractable pain for 14 years from a botched surgery, along with fibromyalgia, arachnoiditis, stiff person syndrome, lupus, Parkinson's disease and insomnia. Cathy is the creator and administrator of the Facebook pages Chronic Illness Awareness and Advocacy Coalition and Pain is Pain.

UK Guideline Warns Against Using Opioids and Most Other Drugs for Chronic Pain

By Pat Anson, PNN Editor

The United Kingdom may be on the verge of adopting even more stringent opioid guidelines than the United States and Canada.  

The UK’s National Institute for Health and Care Excellence (NICE) has released a sweeping guideline drafted by an expert committee that recommends opioid medication not be prescribed for chronic primary pain at any dose due to lack of evidence and risk of addiction.

“Based on their experience, the committee agreed that even short-term use of opioids could be harmful for a chronic condition. The lack of evidence for effectiveness of opioids, along with evidence of long-term harm, persuaded the committee to recommend against opioid use for people with chronic primary pain,” the guideline states.

The NICE guideline doesn’t stop there. It recommends against the use of virtually every other medication commonly used to treat chronic pain, including gabapentinoids, benzodiazepines, acetaminophen (paracetamol), non-steroidal anti-inflammatory drugs (NSAIDS), ketamine, corticosteroids, and antipsychotics. According to NICE, these non-opioid pain relievers may be addictive, have risky side effects and do more harm than good.

“The committee agreed that not commenting on these medicines could result in their continued use in practice, which would be inappropriate given the lack of evidence and possible harms, so they recommended against the use of these treatments,” the guideline says.

The guideline is the first by NICE to address “chronic primary pain” — a vague term used to describe pain conditions that last longer than 3 months, and cause significant emotional distress and disability, such as fibromyalgia, Complex Regional Pain Syndrome, chronic musculoskeletal pain and symptoms that “can’t be accounted for by another diagnosis.”

NICE said the new guideline “should be used alongside” existing recommendations it has already issued for headache, low back pain and sciatica, rheumatoid arthritis, osteoarthritis, spondyloarthritis, endometriosis and irritable bowel syndrome.

The draft guideline recommends that people with chronic primary pain get physical therapy, acupuncture, psychological therapy and regular exercise. Several other alternative therapies, including transcutaneous electrical nerve stimulation (TENS) and manual therapies such as chiropractic care, are not recommended due to lack of evidence.

Surprisingly, the only class of medication that was recommended for chronic primary pain is anti-depressants such as duloxetine (Cymbalta) and fluoxetine (Prozac), even though their use would be off-label.

Most Treatments Don’t Work

In short, the NICE guideline states that few treatments work for chronic primary pain and most should be avoided.

“There is no medical intervention, pharmacological or non-pharmacological, that is helpful for more than a minority of people with chronic pain, and benefits of treatments are modest in terms of effect size and duration. Additional morbidity resulting from treatment for chronic pain is not unusual, so it is important to evaluate the treatments we offer for chronic pain, to focus resources appropriately and to minimise harm,” the guideline warns.

The draft guidance is open for public comment until September 14.

The head of a large association of UK primary care physicians said the NICE recommendations are welcome, as long as the alternative therapies are made widely available.

“Most patients in pain do not want to take medication long-term, and GPs do not want this either, but sometimes medication has been the only thing that brings relief. As such these new guidelines, which focus on alternative therapies, have the potential to be beneficial for patients - but they will need to be guaranteed appropriate access to them,” Professor Martin Marshall, Chair of the Royal College of General Practitioners said in a statement.

“We should also be mindful not to disregard some medications completely as a lack of evidence may be due to a lack of high-quality research, particularly for older drugs, such as paracetamol.”

NICE estimates that chronic pain may affect between one-third and one-half of the UK population. Almost half of people with chronic pain have a diagnosis of depression and two-thirds are unable to work because of it.

The guideline emphasizes that physicians communicate and work collaboratively with patients to understand the symptoms and causes of their pain.  

“Understandably, people with chronic pain expect a clear diagnosis and effective treatment. But its complexity and the fact GPs and specialists alike find chronic pain very challenging to manage, means this is often not possible. This mismatch between patient expectations and treatment outcomes can affect the relationship between healthcare professionals and patients, a possible consequence of which is the prescribing of ineffective but harmful drugs,” Nick Kosky, a psychiatrist and chair of the NICE guideline committee said in a statement.

“This guideline, by fostering a clearer understanding of the evidence for the effectiveness of chronic pain treatments, will help to improve the confidence of healthcare professionals in their conversations with patients. In doing so it will help them better manage both their own and their patient’s expectations.” 

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.  

Most Patients Say Cannabis Effective for Musculoskeletal Pain

By Pat Anson, PNN Editor

The vast majority of people with musculoskeletal pain who have tried medical cannabis say it is an effective pain reliever and over half believe it works better than other pain medications, according to a new study released by the American Academy of Orthopaedic Surgeons.  

Researchers surveyed 629 patients being treated at orthopaedic clinics to see how widely cannabis is being used for chronic muscle and joint pain that can be caused by arthritis, fibromyalgia, osteoporosis and many other conditions.

“Over time, we’ve certainly seen an increase in the use of cannabis to manage musculoskeletal (MSK) pain,” said lead author Timothy Leroux, MD, an orthopaedic surgeon and assistant professor at the University of Toronto.

“There is definite interest to see if cannabis can be used to manage chronic MSK pain, as opposed to other conventional treatments such as anti-inflammatories and opioids. With this study, we wanted to get a lay of the land as to who is using it, what proportion are using and what they perceive the efficacy to be.”

One in five of the patients surveyed said they are currently using or have tried cannabis to manage their MSK pain. Of those, 90% said cannabis was effective, 57% believe it works better than other pain medications, and 40% said it decreased their use of other drugs.

Patients who used cannabis for MSK pain were more likely to have multiple conditions, including depression, back pain, chronic pelvic pain and chronic neck pain. They were also more likely to use muscle relaxants and opioids for pain relief.

The most common form of cannabis used was cannabidiol (39%) and the most common route of ingestion was CBD oil (60%). Over a third of patients said they spent at least $200 per month on cannabis products.

Among the cannabis users, only 26% received a recommendation from a physician. Most said they tried cannabis at the urging of a friend or family member.

“Most doctors, especially orthopaedic surgeons, don’t have prescribing power for cannabis, so there is minimal physician oversight when it comes to cannabis use to manage chronic MSK pain,” said Leroux. “To complicate things, it’s a little bit of a Wild West in the cannabis industry in terms of what you get in a product, namely actual vs. labelled composition, and consistency.

“Another challenge is that we don’t fully know what products, formulations, dosages, and routes of administration are best to manage chronic MSK pain. Given the high rate of use observed in this study and little physician oversight, there’s an impetus for us as a medical community to try to understand what role, if any, cannabis may serve in the management of chronic MSK pain.”

Even among non-users, there was a fair amount of interest in cannabis. Sixty-five percent reported an interest in trying cannabis for MSK pain. Common barriers to using cannabis were stigma and lack of knowledge about its efficacy, doses and routes of administration.

“We tend to associate cannabis with a younger age due to recreational use, but in our study, age was not a significant factor influencing use for the management of chronic MSK pain,” said Leroux. “Patients reported use well into their 80’s, many whom we assumed would want to use more conventional products.

“We’d like to repeat this study in the next few years to see how use and demographics change as people become more comfortable with the idea of cannabis as the norm as well as what role state legalization plays in patients’ attitudes towards its use.”

Should Children Be Prescribed Cymbalta?

By Pat Anson, PNN Editor

The Food and Drug Administration has quietly expanded the use of an antidepressant to treat fibromyalgia in pediatric patients between 13 to 17 years of age – despite the known risk of suicidal behavior by children on antidepressant drugs.  

Cymbalta (also known by its generic name, duloxetine) is a serotonin and norepinephrine reuptake inhibitor (SNRI) made by Eli Lilly that was first approved by the FDA as a treatment for depression in 2004.

In the years that followed, Cymbalta’s use greatly expanded as it was also approved as a treatment for anxiety, diabetic neuropathy, chronic musculoskeletal pain and fibromyalgia in adults.

The approvals came with a major caveat: a black box warning label that specifically cautioned patients and providers that “Cymbalta is not approved for use in pediatric patients” because it could increase the risk of suicidal thinking and behavior in children.

2007 Cymbalta warning label

So why is the FDA now approving the use of Cymbalta by children?  

The federal agency issued no press release when it sent a letter to Eli Lilly on April 20 notifying the company that it was approving its longstanding request to allow Cymbalta to be prescribed for juvenile fibromyalgia. Lilly itself has made no public announcement about the approval.

Health and Human Services Secretary Alex Azar, who oversees the FDA, was President of the U.S. division of Eli Lilly from 2012 to 2017, a period when the cost of Cymbalta doubled.

‘No New Safety Concerns’

The FDA’s approval of Cymbalta for pediatric cases appears to be based on a single placebo-controlled study -- sponsored by Eli Lilly -- in which 184 children with juvenile fibromyalgia were given duloxetine, placebo or a combination of the two over the course of 39 weeks.

Eli Lilly not only funded the study, but its employees designed it, collected data, conducted the analysis, and wrote the article that reported on its findings, which was published last year in the journal of Pediatric Rheumatology.

While the study did not show that duloxetine was significantly better than placebo, patients taking the drug did show a modest improvement in pain severity. Notably, Eli Lilly researchers also said they found “no new safety concerns” about duloxetine.

Which doesn’t mean there were no safety concerns, it just means they didn’t find any new ones. Duloxetine is well known to have side effects in adults, such as fatigue, nausea, mood swings and weight gain.

“The safety profile of duloxetine observed in this study was similar to that observed in previous pediatric duloxetine trials of other indications, as well as in duloxetine trials in adults with FM (fibromyalgia). Nausea, headache, vomiting, and decreased appetite were the most frequently reported AEs (adverse events) in the present study, which are similar to those reported previously in adult population with FM,” wrote lead author Himanshu Upadhyaya, Global Lead Physician in Psychiatry at Eli Lilly.

But a closer look at the study findings – which anyone can see for themselves at clinicaltrials.gov – shows that 6 children taking duloxetine exhibited alarming signs of self-harm. There were two attempted suicides and one intentional drug overdose. One child intentionally injured himself and two had suicidal thoughts. Three other children on duloxetine experienced depression, hallucinations and a seizure.

Granted, nine children in total isn’t that many – but in a small study with 184 participants, it’s concerning – especially when no one in the placebo group had the same behavior or symptoms, according to study results posted on the government-run website.

However, in their published findings in Pediatric Rheumatology, Eli Lilly researchers downplayed the suicidal thinking and other side effects associated with duloxetine, saying they were “not significantly different” than those of children on placebo. The two attempted suicides aren’t even mentioned.

“In the present study, the suicidal ideation events reported with duloxetine were not significantly different from placebo-treated patients. Similar results were reported previously, including the exposure-adjusted analysis of suicidal ideation events, which have not shown any significant difference between duloxetine and placebo,” researchers said.

“None of the SAEs (serious adverse events) reported were considered to be study drug-related and none have led to study discontinuation. There were no deaths reported during the study. There were no significant differences between groups in suicide-related behaviors or ideation.”

Eli Lilly went to great lengths to conduct the study. Its researchers said it took almost 7 years and significant recruitment efforts to find enough children to participate with parental approval. Most of the participants were in the United States, but some were recruited as far away as India and Argentina.

Suicide has long been associated with duloxetine, going back to its earliest clinical trials. A 19-year college student participating in one study killed herself in 2004, four days after being taken off the drug. Four other patients who took duloxetine during clinical trials also committed suicide, although Eli Lilly said at the time there was no evidence directly linking those deaths to the drug.

Withdrawal ‘Brain Zaps’

A common complaint of patients who take duloxetine is how quickly they become addicted and what happens when they stop taking the drug. Many complain of severe withdrawal symptoms such as mood swings, nausea, fatigue and electric-like sensations called “brain zaps.”

PNN columnist Crystal Lindell went through withdrawal when she started weaning herself off Cymbalta in 2015. Her column on that experience (see “How I took Myself Off Cymbalta”) has become a reference point for hundreds of patients trying to get off the drug.

Crystal thinks expanding the use of Cymbalta to include pediatric patients is not a good idea.

“I would urge extraordinary caution when it comes to giving Cymbalta to teenagers,” Crystal says. “When I was first given Cymbalta about seven years ago, I was 29. At that time, the doctor told me I may be too young to take it because it was known to cause suicidal thoughts in young people. He advised me to be in touch with him if that starts to happen. And I was much older than the age group they just approved to take this drug.  

“I hope doctors will be more cautious about giving Cymbalta to teenagers than they have been about giving it to adults. I always advise readers to listen to their doctor first and foremost, but don't be shy about pressing them on which medications they prescribe you. Ask them about side effects and withdrawal so that you can feel comfortable about what you’re taking.”

The FDA’s new warning label for Cymbalta still cautions about suicidal thinking and behavior in children, but no longer warns that the drug is not approved for use by pediatric patients.

NEW CYMBALTA WARNING LABEL

Duloxetine’s checkered history is well known at the FDA. The agency’s adverse events reporting system has recorded over 33,500 serious cases involving duloxetine since 2007, most of them classified as psychiatric disorders. Over 3,900 of those adverse events resulted in death.

Although Eli Lilly’s patent on duloxetine expired years ago, Cymbalta remains a top money-maker for the company. Cymbalta sales during the first quarter of 2020 were up 28% from a year ago to more than $210 million.

In addition to treating juvenile fibromyalgia, Cymbalta could be repurposed in other ways to boost sales for Eli Lilly. Over 300 clinical studies are underway to explore the use of duloxetine to treat a smorgasbord of other conditions, including shingles pain, cancer pain, surgical pain, post-traumatic stress disorder, attention deficit disorder, and cocaine addiction.

In short, a drug with risky side effects that was originally developed to treat depression is being used for health conditions it was never intended to treat. And more could be added to the list.

Treating Chronic Pain With Lasers

By Madora Pennington, PNN Columnist

Months after surgery for my badly broken foot, the last scab finally fell off, revealing to my horror that the surgical incision had not closed. I have Ehlers-Danlos Syndrome (EDS), a genetic condition that prevents my body from building proper collagen. Poor wound healing is a common complication for people like me. 

A search for a treatment that would help led me to Dr. Harold Kraft, a Southern California anesthesiologist who has built an entire practice around using high-powered lasers. Kraft’s main focus is pain --- from sciatica and back pain to neuropathy, neuralgia and myalgia, as well as post-surgical pain and soft tissue injuries. 

Another thing lasers do is facilitate wound healing. After a few appointments, my wound closed but appeared fragile and Frankenstein-looking. With more treatments, it rapidly filled in, coming to look smooth, strong and, surprisingly, pretty.

I was eager to try laser for my Ehlers-Danlos aches as well. My strange body seems to sustain soft-tissue injuries from the ordinary tasks of life, draining my energy and taxing my nervous system. From the laser treatments, I experienced relief I had never before felt.

Kraft has learned a lot from administering over 20,000 treatments on patients. He noticed Ehlers-Danlos patients got exceptional pain relief from the laser treatments, and came to find that nearly all are super-responders.

“About 90% of EDS patients respond to laser treatment, and get faster and more profound pain relief than typical patients,” Kraft notes.

Light Amplification

The word “laser" is an acronym for Light Amplification by the Stimulated Emission of Radiation. No longer limited to science fiction movies, lasers are now a part of everyday life. You’ve probably seen lasers used as pointers during presentations, as bar code scanners, and in DVD players. In medicine, lasers can be used for precision cutting, such as in LASIK vision surgery or for excising a tumor. For cosmetic purposes, a laser can improve skin imperfections or whiten teeth.

Light particles, or photons, from the laser pass through the skin and stimulate the cells’ mitochondria to release anti-inflammatory modulators, nerve and vascular growth factor. This causes healing and repair.

Kraft came to having a pain practice late in life. He had retired from a long career of performing anesthesia during surgery and left medicine entirely for the business world, developing software for data aggregation. All that changed when his wife took their long-suffering pug for a new treatment.

Harley, a most beloved dog, had trouble walking. He had not benefited from joint supporting supplements like glucosamine and chondroitin, nor acupuncture and doggie physical therapy. But after four treatments of high dose laser from a veterinarian, Harley could walk again. The Kraft’s were elated and also intrigued.

Kraft convinced a family friend who had back pain to see that same veterinarian for lasering, even though she is a human. Like Harley, she found pain relief.

Seeing the promise of what this could offer, Kraft began training in laser techniques and got laser machines of his own. He went back to practicing medicine, treating pain exclusively with lasers. Kraft uses Class IV lasers, which are the most powerful available. He employs them at high doses, in order to do the most good for patients. Great care must be taken in this endeavor.

“The more power you use, the more care you need to operate and the more likely that misapplication can cause harm,” Kraft says. “There is no discomfort during treatment, although the patient may feel the heat from the laser. It is powerful, non-invasive, and the results can be permanent or long-lasting.”

Kraft says about 7 out of 10 patients get significant improvement, including chronic pain sufferers who failed at other treatments. Genetics seem to play a factor in how well a patient responds. Some are just faster than others. A small percentage respond immediately. Most experience benefit between 4 and 10 treatments, and only about 30% do not respond after 14 or so treatments.

What does the science say about laser therapy? While there isn’t an abundance of research on the healing power of Class IV laser, some exist and are worth noting:

• A small study in the Journal of Athletic Training concluded that Class IV laser therapy is “an effective treatment modality to increase blood flow in the soft tissues” to promote healing.

• A pilot study assessed Class IV laser therapy for postoperative pain in 100 patients who had coronary bypass surgery, and found it to be effective.

• A double-blind study of tendonitis caused by repetitive-motion found Class IV laser treatments gave long-term relief with no adverse effects.

• Another double-blind study on 38 women with fibromyalgia showed that Class IV laser therapy improves pain, upper body range of motion, and quality of life. 

Chronic and acute pain are notoriously difficult to treat, especially in an era when fewer doctors are willing to treat pain or prescribe opioid medication. Pain patients have fewer options.

Dr. Kraft imagines a world where patients will have easy access to laser therapy at their primary care doctor or physical therapist. In addition to running his busy practice, Dr. Kraft has invented an improved laser, one that would optimize treatment regimen. He hopes to have it to market in two years.

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

I Can’t Imagine Life Without Kratom

By Kimberley Flink, Guest Columnist

I'm 59, a native Floridian and spent most of my entire life actively outdoors. About five years ago, I woke up and could barely move, my body was wracked with intense muscle pain. I was in tears simply brushing my teeth, taking a shower, holding a coffee cup or even opening a door.

If I had to attempt to describe the pain, it would be similar to doing a triathlon and never practicing a day for it. Every muscle ached and throbbed in constant, chronic soreness. I felt like a little old lady when walking, standing and sitting, with groans of pain to boot.

Finally, after several trips to the doctor, they diagnosed me with fibromyalgia and a series of drugs were prescribed: anti-depressants, muscle relaxers, gabapentin and all the typical prescribed pharma arsenals.

Nothing helped with the pain. Instead they gave me side-effects that ranged from horrid headaches, weird sensations in my body, and the list goes on. So I set out to approach a holistic natural path.

Marijuana made me overeat and I didn't like staying high. I cleaned up my diet, took organic superfoods and spent tons on supplements, all to no avail.

Then a friend recommended kratom. And from the first day of taking it I was literally in tears, thanking God for a respite.

I do not even take the recommended dosage, so as to not overuse it, and I do not take kratom every single day, so I do not become addicted.  On the days I don’t take it, I'm suffering and hardly able to get out of bed.

KIMBERLEY FLINK

I cannot imagine my life without kratom, as I am now able to spend time with my granddaughter, go on short outings and function somewhat normally. I do not get high, overeat and have no ill side effects. It gives me a little energy and dials down the pain level severely. 

It would be a serious injustice to not have kratom available to people like myself, who suffer with chronic pain and do not want the heavy-duty drugs that people get addicted to or take their life by overdosing.

To compare kratom with alcohol, nicotine, opioids or other drugs that can cause death is absurd. I know what addiction is and those who say otherwise are simply abusing kratom. Or they’re using some other black market, knock-off product.

Kratom is the only thing that has given me a good portion of a quality life back. I thank God for it!

Kimberley Flink lives in Florida.

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

FDA Warns of Serious Breathing Problems Caused by Gabapentinoids

By Pat Anson, PNN Editor

The U.S. Food and Drug Administration is warning that serious breathing problems can occur in patients who use gabapentin or pregabalin with opioids or other drugs that depress the central nervous system. The elderly and patients with lung problems are at higher risk when they use the drugs, according to an FDA drug safety communication.

The advisory is the latest in a series of warnings about gabapentinoids, a class of nerve medication increasingly prescribed as an alternative to opioid painkillers. There are growing reports of gabapentinoids being abused or raising the risk of overdose and suicide.

“Reports of gabapentinoid abuse alone, and with opioids, have emerged and there are serious consequences of this co-use, including respiratory depression and increased risk of opioid overdose death,” Douglas Throckmorton, MD, deputy director for Regulatory Programs in the FDA’s Center for Drug Evaluation and Research, said in a statement.

“In response to these concerns, we are requiring updates to labeling of gabapentinoids to include new warnings of potential respiratory depressant effects. We are also requiring the drug manufacturers to conduct clinical trials to further evaluate the abuse potential of gabapentinoids, particularly in combination with opioids, with special attention being given to assessing the respiratory depressant effects.”

Gabapentinoid products include gabapentin, which is marketed under the brand name Neurontin, and pregabalin, which is marketed as Lyrica. Generic versions of the drugs are also available.

Gabapentinoids were originally developed to prevent seizures, but their use has tripled over the past 15 years. The drugs are approved to treat a variety of chronic pain conditions, such as fibromyalgia, neuropathy and shingles. They are also widely prescribed off-label.

According to the FDA, over 13 million people filled a prescription for gabapentin in 2016, while over 2 million patients were prescribed pregabalin. Nearly one in five of those patients were also taking opioids.

“Pairing an opioid with any CNS depressant – a gabapentinoid, benzodiazepine, sedating antidepressant, sedating antipsychotic, antihistamine, or other product – will increase the risk of respiratory depression. Shifting treatment from one CNS depressant to another may pose similar risks,” the FDA said.

A Dozen Deaths

The agency said it received 49 case reports of serious breathing problems in patients taking gabapentinoids, including 12 people who died from respiratory depression. It’s advising doctors, caregivers and patients taking gabapentinoids to be alert for signs of confusion, disorientation, dizziness, sleepiness, slow or shallow breathing, unresponsiveness, or bluish-colored lips, fingers and toes.

A 2018 study by Australian researchers found that gabapentinoids often had side effects such as drowsiness, dizziness and nausea. Another study found that combining gabapentin with opioids significantly raises the risk of dying from an overdose. And a recent analysis of calls to U.S. poison control centers found a significant increase in suicide attempts involving gabapentin.

There have also been increasing reports of gabapentin and pregabalin being abused by illicit drug users, who have learned they can use the medications to heighten the high from heroin, marijuana, cocaine and other substances.

A recent study published in JAMA Internal Medicine found little evidence that gabapentinoids should be used off-label to treat pain and said their effectiveness was often exaggerated by prescribing guidelines. The CDC’s 2016 opioid guideline recommends gabapentin and pregabalin dozens of times as alternatives to opioids, without saying a word about their abuse or side effects.

“Our goal in issuing today’s new safety labeling change requirements is to ensure health care professionals and the public understand the risks associated with gabapentinoids when taken with central nervous system depressants like opioids or by patients with underlying respiratory impairment. However, we do not want to unintentionally increase opioid use by turning prescribers away from this class of pain medications,” Throckmorton said.