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The Patient-Reported Outcomes Measurement Information System (PROMIS) initiative. The
PROMIS initiative is researching and developing new ways to measure patient-reported
outcomes (PROs), such as pain, fatigue, physical functioning, emotional distress, and
social role participation that have a major impact on quality-of-life across a variety of
chronic diseases. The goal of this initiative is to improve the reporting and
quantification of changes in PROs. NIAMS supports an effort to develop PROMIS specifically
for use in patients with fibromyalgia.
Improving Symptoms
A better understanding of fibromyalgia and the mechanisms involved in chronic pain are
enabling researchers to find effective treatments for it. Some of the most promising lines
of research in this area include the following:
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Increasing Exercise
Although fibromyalgia is often associated with fatigue that makes exercise difficult,
regular exercise has been shown to be one of the most beneficial treatments for the
condition. A new NIAMS-supported study is trying to determine whether increasing lifestyle
physical activity (that is, adding more exercise such as walking up stairs instead of
taking the elevator) throughout the day produces similar benefits to exercise for
fibromyalgia, improving symptoms such as pain, fatigue, and tenderness. The study is also
examining the potential mechanisms by which lifestyle physical activity might influence
symptoms. Other research supported by NIAMS is examining the effectiveness of a 16-week
program of a simplified form of Tai Chi on pain and other measures such as sleep quality,
fatigue, anxiety, and depression.
NIAMS-supported research is also examining ways to help people maintain helpful exercise
programs. Because many people with fibromyalgia associate increased exercise with
increased pain, doctors and therapists often have a difficult time getting patients to
stick with their exercise program. The new research is examining patients' fears that
cause them to avoid exercise as well as behavioral therapies to reduce fears and help them
maintain exercise.
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Improving Sleep
Researchers supported by NIAMS are investigating ways to improve sleep for people with
fibromyalgia whose sleep problems persist despite treatment with medications. One team has
observed that fibromyalgia patients with persistent sleep problems share characteristics
with people who have sleep-disordered breathing—a group of disorders, the most common of
which is the obstructive sleep apnea, characterized by pauses in breathing during sleep.
These researchers are studying whether continuous positive airway pressure (CPAP, a
therapy administered by a machine that increases air pressure in the throat to hold it
open during sleep) might improve the symptoms of fibromyalgia.
Other groups of researchers are examining the link between sleep disturbance and chronic
pain in fibromyalgia and are studying whether behavioral therapy for insomnia might
improve fibromyalgia symptoms.
Studying and Targeting Treatments
In addition to exercise and improving sleep, NIAMS-supported researchers are looking at
different ways to reduce pain and other symptoms of fibromyalgia. Potential therapies
under study include transcranial magnetic stimulation (TMS) and vagus nerve stimulation.
TMS is a therapy in which an electrical current is passed through an electromagnetic coil
placed on the scalp, inducing a small electrical current within the underlying cortex.
Recent research shows that the therapy not only decreases depressive symptoms in depressed
patients, but also is effective in reducing pain. The new study will examine whether
TMS is effective in improving pain in people with widespread chronic pain disorder,
including fibromyalgia.
Vagus nerve stimulation is a treatment that uses a device similar to a pacemaker to
administer regular, mild pulses of electrical energy to the brain by way of the vagus
nerve. The vagus nerve runs from the brain stem to the lower abdomen and controls body
functions, including heart rate, that are not under voluntary control.
NIAMS recently funded its first study of a drug treatment for FM. The study will
measure the effectiveness of gabapentin, an anticonvulsant medication, in reducing
symptoms of FM. Gabapentin has been found to relieve chronic pain caused by nervous
system disorders, and it was recently approved by FDA for the treatment of
persistent, severe pain that can follow an episode of shingles.
Scientists recognize that people with FM often fall into distinct subgroups that adapt
to and cope with their symptoms differently. They also realize that these subgroups
may respond to treatments differently. One NIAMS-funded team of researchers has
divided people with FM into three groups based on how they cope with the
condition. Relative to other chronic pain patients, those in the first group have
higher levels of pain and report more interference in their life due to pain. They
also have higher levels of emotional distress, feel less control over their lives, and
are less active.
The second group reports receiving less support from others, higher levels of
negative responses from significant others, and lower levels of supportive responses
from significant others. Those in the third group are considered adaptive copers; they
have less pain, report less interference in their lives due to pain, and have
less emotional distress. Members of this last group feel more control over their lives
and are more active. On the premise that the better you understand the subgroups,
the better you can tailor treatments to fit them, the researchers now are trying to
design and test different programs for each group, combining physical
therapy, interpersonal skills training, and supportive counseling.
Research on Complementary and Alternative Medicine (CAM)
According to reviewers who have assessed the research on CAM and Fibromyalgia (FM), much
of the research is still preliminary, and evidence of effectiveness for the
various therapies used is limited.
Research on Acupuncture
Stimulation of anatomical points with thin metallic needles—for FM has produced
mixed results. One review article notes that three studies found some evidence to
support the use of electroacupuncture (in which the needles are pulsed with
electric current). However, the effects of electroacupuncture in these studies were
mostly short lived, and two studies of traditional acupuncture had negative results.
Some researchers believe that low levels of magnesium may contribute to FM. However,
there is no conclusive scientific evidence that magnesium supplements relieve FM
symptoms. Two small studies had conflicting results.
A review of the research on massage therapy for FM notes only modest, preliminary
support. Two studies had some positive findings, but two others found either no benefits
or only short-term improvements.
Supplements containing the amino acid derivative SAMe are used for a variety of
conditions. Although several small studies of SAMe for FM have had mixed results, there
is some evidence of a benefit. Reviewers conclude that more research is needed.
Finally, according to reviewers, research evidence is insufficient to draw
conclusions about the effectiveness of other CAM treatments—biofeedback, chiropractic
care, hypnosis, and magnet therapy—used for FM.
NCCAM Research on Fibromyalgia
The National Center for Complementary and Alternative Medicine (NCCAM) funds
clinical trials that look at CAM for FM. Recent projects include studies of:
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The effects of tai chi on FM patients' musculoskeletal pain, fatigue, sleep
quality, psychological distress, physical performance, and health status.
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Brain-imaging techniques for determining whether acupuncture relieves pain due
to FM.
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The effectiveness of a form of electroencephalograph (EEG) biofeedback in
treating FM.
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The National Institute of Arthritis and Musculoskeletal and Skin Diseases
(NIAMS) sponsors research that will improve scientists' understanding of the
specific problems that cause or accompany Fibromyalgia (FM), in turn helping them
to develop better ways to diagnose, treat, and prevent this medical condition.
