The National Institute of Health (NIH) is easily the biggest funder of medical research in the world. Many research groups depend on the NIH for the majority of their funding.

Health Rising’s recent review of NIH funded studies on chronic fatigue syndrome revealed a small (14 studies underway) but rich list of studies. From an analysis of the gut microbiome, to the effects of exercise on the immune system, to studies on Epstein-Barr virus infection, to cerebral spinal fluid studies, the NIH was looking hard for the cause of ME/CFS. If the NIH isn’t funding ME/CFS much, the studies it does fund are focused strictly pathophysiology.


The NIH is taking a very different path with FM than it is with ME/CFS

The fact that not one treatment study was funded suggests the NIH is still floundering in that area.

The opposite picture is present for FM. The NIH is placing very little emphasis, at least this year, on trying to understand why or how fibromyalgia occurs (5  studies) but is more focused on treating it (14 studies).

Lackluster Attempt at Understanding Pathophysiology

Fibromyalgia is the sole focus of only three of the (only) five pathophysiological studies the NIH is funding.  Two of the studies (immune study, SFN study) focused purely on FM could conceivably produce a breakthrough in our understanding of it. The other three studies (placebo effect/cognitive processing) are decidedly ho-hum matters.

The NIH did fund a small nerve fiber (SFN) study but with @40% of FM patients having SFN it was surprising that three or four studies weren’t being funded.  With so many intriguing central nervous system findings it was remarkable, as well, to see the NIH funding only two pure brain imaging studies – one of them very small.

A Mind/Body Alternative Medicine Approach to Treatment

A strong focus on treatment would seem to be good news.  Treatment should be, after all, the end result of research.  Unfortunately the NIH’s treatment studies don’t fare much better.  Half of the NIH’s treatment studies are on mind/body approaches to FM (CBT, emotional processing, MBSR, Tai chi, placebo).  Several more studies focus on alternative approaches  to FM such as acupuncture, blue green algae and Chinese medicine.


Mind/body and alternative health approaches dominate the NIH’s approaches to treating fibromyalgia

Past studies have shown these approaches can be helpful, but are they effective enough for the NIH to put most of its eggs in the mind/body basket/alternative health basket? Apparently, fibromyalgia’s home Institute at the NIH, NIAMS, thinks so. It is funding studies on propanolol and TENS, but is putting most of its money on behavioral approaches to FM (4/6 studies) to treatment. It’s not putting a dime into understanding FM pathophysiology.

NIH appears to be more reinventing the wheel in the treatment arena than moving forward. Dan Moricoli’s and other mind/body recovery stories attest to the fact that that these practices can be effective in the right person. Still no less than five yoga, four MBSR/meditation and ten Tai Chi FM studies have been done in the past five years.

This doesn’t mean the NIH is not funding good studies – it’s just not funding enough of them. The etanercept and propanolol studies could open new windows on treating FM.  Finding that either an autoimmune drug or a beta blocker is helpful in FM would be news.  Assessing the long term effects of opioids in FM is important given the many FM patients using them.  We all want to know more about small fiber neuropathy and finding a immune trigger for chronic pain would certainly open doors.

ME/CFS may not be funded as well but many of the ME/CFS studies could result in legitimate breakthroughs. The same, unfortunately, can’t be said for most of the NIH’s FM studies. That’s a real surprise given how rich in possibilities the FM field is.

It’s possible that  NIAMS is simply blocking; i.e. not funding studies on pathophysiology but it’s not clear whether these studies are not getting funded because NIAMS is not interested – or if the research field is simply ignoring FM? Note that the neurological institute (NINDS) is funding half of the pathophysiological studies while NIAMS, as noted earlier, is funding none.  Assessing the number of FM grant applications forwarded to the NIH would be a good place for advocates to start figuring out what is going on there.

Active NIH Funded Studies in 2015


Wanted: Patients In All Sorts of Pain – An Immune Pain Study

No moderate pain patients allowed. One part of this study requires participants to have at least three of the following disorders: temporomandibular disorder (TMD), episodic migraine (EM), vulvar vestibulitis syndrome (VVS), fibromyalgia (FM), and irritable bowel syndrome (IBS) – to participate.

They believe that miRNA’s are activating an immune receptor (involved in infection interestingly enough) TLR8 and a protein complex called NFKB, known to enhance the pro-inflammatory cytokine response.  Ultimately this research could lead to immune based therapies for chronic pain.  Who can we thank for this study? People with TMD – the dental institute is funding this study.


Small Fiber Neuropathy in Adolescents with Chronic Widespread Pain 

small nerve fibers

Just one fibromyalgia small fiber neuropathy study?

Louise Oaklander was one of the first researchers to identify small fiber neuropathy in FM patients. She found quite a bit of it but she believes the current testing regimens significantly underdiagnose SFN in adolescents. In this big study (almost $700,000), Oaklander will assess different SFN tests AND try to get at the cause of SFN using blood tests and skin biopsies. The study will end in 2020 and is being funding by NINDS (who else?).

  • Funding Institute: NINDS

Clearing the Fog Around FibroFog? 

This ongoing (and rather small $121,000) study will a) measure the cognitive problems in FM and people with depression and b) use an MRI to compare how their brains function during a cognitive test. The researchers anticipate FM patients and people with depression will have different kinds of cognitive problems and the MRI’s will reveal different patterns of brain functioning are present.

Risk Factors For Chronic Pain

Talk about a long-running study. This massive project which began in 2003 seeks to identify the psychological and physiological risk factors, clusters and genetic factors that predispose people to fibromyalgia and other chronic pain conditions.  This project has produced about 100 studies thus far and it’s still going strong – it’s getting a cool $1,314,211 for this year.

  • Funding Institute: NINDS

Understanding the Placebo Effect in Fibromyalgia

This study will give FM patients a placebo – an intravenous injection guaranteed to have pain reducing effects – and then use PET scans to monitor the activation of their opioid  receptors. They will use the scans to assess the integrity of this pain reducing system and to find biomarkers that will enable researchers to better assess its activity.  This ongoing study, last funded in 2014 is expected to wrap up in 2020.



Biological Approaches

An Autoimmune Drug to Reduce Pain in Fibromyalgia?

The hypothesis behind this intriguing study is that pro-inflammatory cytokines are dysregulating opioid neurotransmission in FM patients; i.e. they are knocking down the opioid based system of pain relief in FM. First the investigators are going to determine the status of  mu opioid neurotransmission in FM patients and then they are going to give them Etanercept, a drug used in autoimmune disorders. They predict that Etanercept will restore opioid neurotransmission and reduce pain in FM.  It worked in animal models. Let’s hope it works in FM as well. This $250,000 study ends in 2018.

  • Funding Institute: The National Institute on Drug Abuse (NIDA)

Acupuncture – Sort of – to Reduce Pain in Fibromyalgia

The proponents of this study believe that electro-acupuncture (EA) is better than traditional acupuncture in reducing pain. In fact, one study found that electro-acupuncture (EA) was more effective than placebo in reducing pain but traditional acupuncture was not. They believe this may be because the needles in acupuncture affect the ever so sensitive somatosensory system in FM.  They’re testing their hypothesis using (1) EA and something called (2) “mock laser (ML) acupuncture” – a newer form of sham acupuncture that does not affect the somatosensory system negatively.

This rather expensive study ($645,000) will end in 2018


Blue Green Algae for Pain AND Depression?

The authors of this mouse study propose that common pathways underlie both FM and depression. Calling this conjunction of pathways a “dangerous pathological situation”, they state that having FM can trigger depression and depression FM.

Their solution – affect serotonin receptor functioning using extracts, fractions, and purified compounds from marine blue-green algae collected off of Panama. They noted that the task of examining the marine environment for therapeutic compounds has only recently begun.

Traditional Chinese Medicine (TCM) Takes it’s Shot at Fibromyalgia

This five year study – which is ending next year – examines how effective ten weeks of TCM is for the treatment of fibromyalgia. The funder? Obviously NCCAM.


Opioids – Do They Help or Hurt in Fibromyalgia?

Many people with FM rely on opioids but the long term effects are uncertain. This Stanford study will determine what effects they have on the key neurological aspects of FM; i.e. the pain pathways in the brain and the spinal cord, as well, interestingly enough, on the activity of the “reward system” in FM. Finally a long term study will assess how effective they are at relieving pain over time.

The beta blocker reduces pain in animals. Will it in humans as well?

The beta blocker reduces pain in animals. Will it in humans as well?

Another Low Dose Drug for Fibromyalgia? 

First there was low dose naltrexone. Now these Utah researchers – no doubt in concert with the Lights who explored propanolol’s use in ME/CFS – propose the low dose propanolol – a beta blocker may be effective at reducing the delayed onset muscle pain seen after exercise.  In this big study (200 FM patients) (they must have had some good preliminary data to score a study this big – they’re going to assess post exertional malaise (PEM) and gene expression changes after propanolol.

This 330,000 study will last for two years and is beginning this month at the University of Utah. (Contact email: akiko.okifuji@hsc.utah.edu).

  • Funding Institute: NIAMS

Electrical Stimulation to Reduce Pain

You might not think that stimulation could reverse a hyperexcitable nervous system condition, but it’s the descending pathways from the brain to the spinal cord that inhibit pain that aren’t working well in FM.  Enter transcutaneous electrical nerve stimulation (TENS) to get those inhibitory pathways up and running again.

 This five-year $700,000 (in 2015) study will determine if using a TENS unit will decrease pain and fatigue and increase functionality. It ends in 2018

  • Funding Institute: NIAMS

Combined Biological and Behavioral

The Drug and CBT Study

Both tramadol and CBT are used in FM to reduce pain and increase activity but rarely are they used together. This study combines tramadol and a version of CBT adopted for FM to see FM patients do better on both. It will also use actigraphy to see if poor sleep or increased activity are associated with increased fatigue and pain. Interestingly, they believe they won’t be. They will also evaluate psychological and neurophysiological variables.

This big 5 year study ($1,000,000 in 2015) ends next year.

  • Funding Institute: NIAMS

Behavioral and Mind/Body


John Kabat Zinn developed Mindfulness Based Stress Reduction (MBSR) – a mindfulness and meditation-based approach to managing disease for people with chronic pain who weren’t able to tolerate pain drugs. That makes a natural for fibromyalgia. This Yale University study is slated to end in 2017.

Yoga vs Exercise? 


Mindful stretching and breathing vs graduated exercise (meditation vs aerobics)…this one is going to be interesting. The Veteran Affairs is funding this study ending in 2017.

  • Funding Institute: Veterans Affairs

Catastrophic Reductions in Chronic Pain?


Studies indicate catastrophizing – focusing on the worst that can happen – increases pain….

Catastrophizing – ruminating on the worst that could happen – definitely increases pain sensitivity but no one really knows why.  These researchers have an idea.  They believe that catastrophizing activates the brain areas that process the emotional aspects of pain (e.g., anterior insula and medial thalamus).(There’s apparently a brain area for everything.)

They are going to reduce catastrophizing by using cognitive behavioral therapy (CBT) and then see if their a) pain drops and as it does, if the activity of the parts of the brain involved in the emotional response to pain reduces as well.  This very expensive study ($700,000 plus) ends in 2019.

  • Funding Institute: NIAMS

Neuromuscular Training Plus CBT for Teens

This small study seeks to use a different kind of exercise called neuromuscular training in conjunction with CBT to reduce pain and hopefully increase physical activity in teenagers with FM.  This type of exercise is believed to limit post-exercise muscle soreness. This “cheap” study ($165,000) ends in 2016.

  • Funding Institute: NIAMS

An Upgrade to CBT? Emotional Processing For FM

Stating that many people with FM have either increased rates of lifetime trauma or problems with stress or emotional regulation, this large study focuses on emotional processing. The authors propose that CBT’s inability to directly address stress and emotional dysregulation has blunted its effectiveness.

They also state they have “solid preliminary data” on the efficacy of “emotion regulation based interventions for FM”.  NIAMS apparently agreed; this is a big expensive study ($600,000) that’s been funded since 2010 (making it probably a $3 million or so study).

The study compares emotional exposure therapy (EET) and standard cognitive-behavioral therapy (CBT). It ends in 2016.

  • Funding Institute: NIAMS

Tai Chi – a First Line Treatment for Fibromyalgia?

The authors are so excited about Tai Chi for fibromyalgia that they believe their results will show that it should be a “first-line” treatment; i.e. it should be one of the first therapies doctors recommend.  That’s a tall order but the same researcher has proposed that Tai Chi be used in other rheumatological disorders such as osteoarthritis and rheumatoid arthritis

This study will assess the short and long term effectiveness of Tai Chi vs aerobic exercise in over 200 patients using a variety of Tai Chi instructors.



Bright Light Treatments to Restore Sleep Patterns (and reduce pain) – in Veterans

This is not a fibromyalgia study but given all the sleep problems in FM and ME/CFS it may very well apply. The authors note that delayed sleep patterns (late sleep) is associated with increased anger, depression, anxiety, fatigue and physical function.  They will use a morning bright light treatment to try and restore normal sleep patterns and reduce chronic pain and improve PTSD symptoms, depression, anxiety and sleep in U.S. veterans.



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