Fibromyalgia Patients Needed for Online Therapy Study

By Pat Anson, PNN Editor

A digital therapeutics company is looking for volunteers to participate in a clinical trial to see if smartphone-based therapy can improve symptoms of fibromyalgia.

Swing Therapeutics recently announced that its acceptance and commitment therapy program (ACT), a form of cognitive behavioral therapy (CBT), has received Breakthrough Device Designation from the Food and Drug Administration. CBT is a form of psychotherapy, in which patients are encouraged to reduce unhelpful thinking and behavior.

“Currently, most people living with chronic pain conditions like fibromyalgia are offered medications and some suggestions for modifying their lifestyle. Behavioral therapies have evidence supporting their effectiveness for pain management, but are not widely available or easily accessed by the average individual,” said David Williams, PhD, Associate Director of Chronic Pain and Fatigue Research Center at the University of Michigan, who is an advisor to Swing Therapeutics.

The company says a pilot study of its online therapy program has shown promise in managing fibromyalgia, a poorly understood disorder characterized by widespread body pain, fatigue, poor sleep and depression. The self-guided daily program includes interactive lessons and exercises designed to help fibromyalgia sufferers understand, accept and manage their symptoms. The core program lasts 12 weeks, followed by a maintenance phase for extended use.

Swing is looking for 500 participants in the U.S. who are at least 22 years of age and have a diagnosis of fibromyalgia. The digital therapy program can be conducted at home, with no in-person medical visits or medications required.  Participants will receive compensation after completing surveys at the end of the 12-week program. Click here to learn more about the study.

“Our team is committed to creating valuable digital therapies and demonstrating strong clinical evidence to support their use. The results of our initial studies are encouraging, and with the support of the FDA, we look forward to optimizing the product as we advance through our pivotal trial,” said Mike Rosenbluth, PhD, founder and CEO of Swing Therapeutics.

The FDA has approved only three drugs to treat fibromyalgia: the antidepressants duloxetine (Cymbalta) and milnacipran (Savella), and the anti-seizure medication pregabalin (Lyrica). Many patients say the drugs are ineffective and have side effects. A recent analysis found little evidence to support the long-term use of any medication or therapy to treat fibromyalgia.

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.

The Truth About Chronic Pain

By Dr. Rachel Zoffness, PNN Columnist

I’ve never been an athlete, but I’ve always loved exercising because of how it makes me feel. One beautiful spring day, I went for a run. On the way downhill, I was stopped by a sudden pain in my knee. When I woke the next morning, I couldn’t step out of bed without burning pain radiating from my feet, up my leg and into my hip.

I was couch-bound for the better part of a year. I saw countless doctors, was prescribed many medications, and would’ve done anything to stop the pain. That was the beginning of a decade-long journey with chronic pain.

I’ve dedicated my life to understanding pain, and not just because of that injury.

I’m a pain psychologist and assistant clinical professor at UC San Francisco School of Medicine, where I teach pain neuroscience to medical residents. I also founded a private practice dedicated to people living with chronic pain.

One of my earliest patients was a teenager. He’d been bedridden with multiple medical diagnoses for four years, seen 12 physicians and tried 40 medications. But nothing worked.

Not surprisingly, he was depressed and anxious. He had no life, no friends and no hope.

DR. RACHEL ZOFFNESS

As a pain psychologist, I use cognitive behavioral therapy (CBT) as one of my primary treatment tools, so we started a CBT-for-pain program. In addition to other strategies, it involved “pacing” or resuming select activities one small step at a time.

It was hard work, but little by little, he got healthier. As his functioning and mood improved, his pain did, too. Within 6 months he resumed school and rejoined his soccer team. His pain wasn’t gone – but it was significantly reduced and he knew how to manage it. He says pain will never control his life again.

Many of us have noticed this link between how we feel emotionally and how we feel physically. That’s because pain is never purely physical. This is confirmed by neuroscience research indicating that pain is produced by multiple parts of the brain, including the cerebral cortex (responsible for thoughts), prefrontal cortex (which regulates attentional processes), and the limbic system – your brain’s emotion center.

Dialing Back Pain

Imagine that you have a “pain dial” in your central nervous system that controls pain intensity. The function of this dial is to protect you from danger or harm. It can be turned up or turned down by many factors, including:

1. Stress and anxiety

2. Mood

3. Attention (what you’re focusing on)

When you’re feeling stressed and anxious – your thoughts are worried, your muscles are tense and tight, and the pain volume is turned up.  

When your mood is low, you’re miserable and depressed, and your brain similarly amplifies pain volume. 

This is also true when your attention is focused on pain. When you’ve stopped going to work, seeing friends and engaging in hobbies, your prefrontal cortex (which controls attention) sends a message to your pain dial, turning it way up. 

However, the opposite is also true. 

When stress and anxiety are low – your body is relaxed, your thoughts are calm and you’re feeling safe. Your cerebral cortex and limbic system send messages to your pain dial, lowering the volume so that pain feels less bad. 

When your mood is high, your thoughts are positive, you’re feeling happy and you’re engaged in pleasurable activities. Your brain determines that little protection is needed, so pain volume is reduced. 

And finally, when you’re distracted – you’re absorbed in activities, like watching funny movies with friends. The pain dial is turned down, so pain is less bad. 

In summary, when you’re relaxed, happy, distracted, and feeling safe, your pain volume is lower. The pain is still there -- it hasn’t magically disappeared -- but it’s quieter. Softer. Less. 

The truth about chronic pain is this: Your thoughts, beliefs, emotions and attention can all adjust pain volume. 

This does not mean that pain is “all in your head.” It isn’t. Your pain is real, as real as mine, and no one should ever tell us otherwise. It does mean that there are many ways to change pain. One is medication. Multiple medications have been shown to effectively turn down the pain dial.  

There are other methods for lowering pain volume, too. CBT, mindfulness and biofeedback are three biobehavioral approaches to pain management that research suggests can be helpful. They aren’t magic cures and they take time. But if you’ve never tried to manage your pain with these techniques, consider them. They’ve helped me immensely on my chronic pain journey. 

When I was learning about mindfulness, I remember thinking, “What could mindfulness possibly have to do with physical pain?”  

And then something fascinating happened.  

During the first year of my practice, my pain changed. It didn’t go away entirely and I wasn’t cured. But the pain changed. It became less intense, less frequent, less distracting, and got less in the way of the rest of my life. 

Rachel Zoffness, PhD, is a pain psychologist and assistant clinical professor at the UCSF School of Medicine. Rachel serves on the Steering Committee of the American Association of Pain Psychology, where she founded the Pediatric Division. She is the author of The Chronic Pain and Illness Workbook for Teens. You can find Rachel on Twitter @DrZoffness.  

A New Psychological Treatment for Chronic Pain

By Ann Marie Gaudon, PNN Columnist

Cognitive behavioural therapy (CBT) has dominated the field of psychological treatment for chronic pain for the last three decades. Studies have shown that it is effective, yet some researchers say CBT also has its limits and could be improved upon.

As CBT treatment approaches continue to evolve, what is noteworthy is a departure from the logic of everyday thinking. “Suffering” is not seen as pathology, but rather as inherent in the human condition. We don’t want it and we don’t like it, but suffering is inescapable.

Following this principle, the utility of “normal thinking, analyzing, and problem-solving” is called into question. Our brains have evolved into powerful problem-solvers that serve very well with things are external to us. For example:

Problem: your car malfunctions and no longer starts. If you have the knowledge and skills, you find the problem and repair the car. Problem solved. If you do not have the skills, you find someone who does and repairs it for you. Problem solved.

But chronic pain is an internal problem that cannot be easily solved. No matter the effort from our powerful problem-solving brains, doctors and patients often cannot work it out. For a sufferer to spend a lifetime attempting to analyze and logically think their way to being pain-free can be a lifetime spent in futility.

Acceptance and Commitment Therapy

Newer psychological approaches such as Acceptance and Commitment Therapy (ACT) are guided by the premise that we cannot change the pain we’re left with, so let’s change our response to that pain. ACT was outlined in a 2014 article in the journal American Psychologist.

ACT differs notably from traditional CBT in method. Rather than challenging and changing thoughts, ACT seeks to reduce their influence over our behaviour. This core treatment process is called “psychological flexibility,” which is the ability to contact the present moment fully and consciously, based on what the situation affords.

In other words, we act on our long-term values rather than short term impulses, thoughts and feelings. I have a personal example of this:

“Knowing that I love to dine out and see live theatre, my partner reserved an evening of these as a surprise birthday present for me. After the reservations were made, I endured a serious back injury, which makes sitting for long periods particularly painful. He offered to cancel immediately, but I stopped him.

My thoughts told me, ‘Don’t go! You’ll be in more pain. Stay home and protect yourself!’

I applied a few of the many skills I have learned through ACT and was able to hold these thoughts lightly, and essentially not buy into them. I committed to continue with the dinner and theatre plans, and accept the pain in the service of my value of nurturing a social life. Result: my pain was not in charge -- I was.”

Why would one choose these strategies? It’s because thoughts and emotions tend to be unreliable indicators of long-term value. They ebb and flow constantly and we have little control over them. If we act based solely on them, we can lose out on experiences that bring true meaning and vitality to our lives.

In my case, I could have held onto my thoughts tightly and isolated myself at home with my pain, but instead I chose not to buy into those thoughts, to be willing to have the pain (acceptance), and commit to an experience which brought richness to my life. I knew my evening out would not reduce or eliminate my pain. I chose to do something of value to me -- the pain came along for the ride.

The catch is that unhelpful thoughts and emotions can dominate without a person even being aware of them. This results in “psychological inflexibility,” which leads to rigid, ineffective behaviour. If I let my thoughts run the show, the result would have been that I isolated myself at home with my pain and likely more suffering. Other positive behaviours and experiences would have been essentially blocked from me. No thank you.

Evidence to support ACT for chronic pain continues to grow, and its efficacy is about the same as CBT at this point. This is no small feat, considering CBT has been the gold standard for decades.

There are at least six randomized controlled trials which support the use of ACT for chronic pain. Most show ACT increases the acceptance of pain, along with improvements in anxiety, depression, and reductions in disability. This psychological flexibility significantly improves life satisfaction, disability, emotional distress and fear of movement.

It will be interesting to see future studies as ACT continues to advance and helps us find new and different ways “to act successfully in the world.”

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.

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

Can Reading Help Relieve Chronic Pain?

By Pat Anson, Editor

A good book is not only hard to put down -- it may also help relieve symptoms of chronic pain by triggering positive memories, according to a small British study.

Researchers at the University of Liverpool brought together a group of ten people with severe chronic pain once a week to read literature together aloud. The reading material included short stories, novels and poetry, and covered a wide variety of genres and topics.

While passages were read aloud in the “Shared Reading” exercise, regular pauses were taken to encourage participants to reflect on what is being read, on the thoughts or memories it stirred, and how the reading matter related to their lives.

Researchers compared the Shared Reading group to another group practicing a form of cognitive behavioral therapy (CBT).

While participants in the CBT group were encouraged to manage their emotions by focusing on the pain experience, Shared Reading encouraged pain sufferers to recall positive memories from their past before the onset of chronic pain.

"Our study indicated that shared reading could potentially be an alternative to CBT in bringing into conscious awareness areas of emotional pain otherwise passively suffered by chronic pain patients,” said Josie Billington, a researcher at the University’s Centre for Research into Reading, Literature and Society.

"The encouragement of greater confrontation and tolerance of emotional difficulty that Sharing Reading provides makes it valuable as a longer-term follow-up or adjunct to CBT's concentration on short-term management of emotion."

Researchers say Shared Reading has a therapeutic effect because it helps participants recall a variety of life experiences -- from work, childhood, family and relationships -- not just memories that involve chronic pain.

The study, published in the BMJ Journal for Medical Humanities, was funded by the British Academy.

While many pain sufferers are deeply skeptical of CBT, meditation and similar forms of “mindfulness” therapy, there is evidence that they work for some. A recent study found that CBT lessened pain and improved function better than standard treatments for low back pain.

Another study at Wake Forest University found that mindfulness meditation appears to activate parts of the brain associated with pain control.

Negative Thoughts About Sleep Make Pain Worse

By Pat Anson, Editor

Negative thoughts about pain and not being able to sleep can worsen chronic pain conditions like fibromyalgia, arthritis and back pain, according to British researchers.

“Pain-related sleep beliefs appear to be an integral part of chronic pain patients' insomnia experience,” said Nicole Tang, a psychologist in the Sleep and Pain Laboratory at the University of Warwick. "Thoughts can have a direct and/or indirect impact on our emotion, behaviour and even physiology. The way how we think about sleep and its interaction with pain can influence the way how we cope with pain and manage sleeplessness.”

Tang and her colleagues developed a scale to measure beliefs about sleep and pain in chronic pain patients, along with the quality of their sleep.

The scale was tested on four groups of patients suffering from long-term pain and bad sleeping patterns, and found to be a reliable predictor of future pain and insomnia.

"This scale provides a useful clinical tool to assess and monitor treatment progress during these therapies," said Esther Afolalu, a graduate student and researcher at the University of Warwick. 

university of warwick

"Current psychological treatments for chronic pain have mostly focused on pain management and a lesser emphasis on sleep but there is a recent interest in developing therapies to tackle both pain and sleep problems simultaneously."

Researchers found that people who believe they won't be able to sleep because of their pain are more likely to suffer from insomnia, thus causing more pain. The vicious cycle of pain and sleeping problems was significantly reduced after patients received instructions in cognitive-behavioural therapy (CBT), a form of psychotherapy in which a therapist works with a patient to reduce unhelpful thinking and behavior.

The study, published in the Journal of Clinical Sleep Medicine, is not the first to explore the connection between pain and poor sleep.

A 2015 study published in the journal PAIN linked insomnia and impaired sleep to reduced pain tolerance in a large sample of over 10,000 adults in Norway. Those who had trouble sleeping at least once a week had a 52% lower pain tolerance, while those who reported insomnia once a month had a 24% lower tolerance for pain.