Fibromyalgia Clinical Trial
Official title:
Subgroups of Fibromyalgia Syndrome (FMS): Symptoms, Beliefs, and Tailored Treatment
Fibromyalgia syndrome (FMS) refers to a set of symptoms that include exhaustion, muscle pain, and tender points, where slight pressure can cause pain. Doctors do not know what causes FMS or how to cure it, but some treatments have helped relieve its symptoms. Progressive exercise, in which exercise is started at low levels and then increased, is one of the most reliable treatments, but people with FMS often avoid exercise or stop after completing exercise programs. This research will focus on the idea that people with FMS do not exercise because they are afraid of injury or have had a negative experience exercising. Participants will undergo one or a combination of several different treatments that aim to reduce fear of exercising. The different treatments will then be evaluated on their effectiveness in reducing disability among people with FMS.
Fibromyalgia syndrome (FMS) is a condition without a known cause or cure. Differing theories
place the blame on abnormal sensitivity to pain receptors in the brain, changes in
metabolism and hormones, abnormalities in the autonomic nervous system, sleep disturbances,
infection, or injury. A diagnosis of FMS, therefore, is based on a set of symptoms. These
include pain in muscles, ligaments, and tendons; fatigue; and multiple tender points on the
body, where even slight pressure causes pain.
Although there is no cure, FMS can be treated to reduce the severity or presence of
symptoms. One of the most reliable ways to do this is through progressive exercise, which
involves starting at low levels of exercise and building up to longer and more strenuous
levels. Despite the benefit of exercise, FSM sufferers often drop out of supervised exercise
programs or discontinue exercise once they are no longer supervised. Some FMS patients may
have a fear-based avoidance of exercise, believing it will provoke pain or deterioration of
their condition and experiencing significant negative emotional arousal when they exercise.
This may be due to a prior painful or uncomfortable experience while exercising.
This study will employ multiple treatments that are usually used for treatment of phobias
and will aim to reduce fear, increase exercising, and improve FMS symptoms. Under the
purview of cognitive behavioral therapy (CBT) are multiple types of treatments. Cognitive
restructuring (CR) and coping skills training (ST) paired together address maladaptive
beliefs and facilitate the development of more effective coping strategies. Exposure therapy
(ET) reduces the level of emotional arousal when patients are exposed to the feared
stimulus, in this case exercising. Attention control (AC) treatment, not a type of CBT,
provides patients with support and controls for nonspecific factors related to exposure to
their feared stimulus. AC will be used as the control treatment in this study.
Participation in this study will last 4 months. After recruitment and an initial evaluation,
participants will be placed on a waiting list for 8 weeks to determine whether their
symptoms improve or change naturally. They will then be reassessed and randomly assigned to
one of the following groups for 8 weeks of treatment:
1. CR+ST: This group will help participants develop adaptive ways of thinking and acting
to alter maladaptive beliefs in general and beliefs about certain exercises in
specific.
2. ET: This group will help participants to decrease their fear response during specific
exercises through progressive, controlled exposure to the feared stimulus.
3. COMB: This group will combine CR+ST and ET treatment plans so that adaptive thoughts
and behaviors will be emphasized in the first 4 weeks, and exposure to feared stimuli
will be emphasized in the second 4 weeks.
4. AC: This group will offer participants non-directive, supportive counseling. Each
treatment group will meet in weekly 90-minute group sessions for the first 4 weeks and
in weekly 60-minute individual sessions for the second 4 weeks. Participants will have
60-minute physical therapy sessions accompanying every treatment session. Participants
will also be given weekly homework assignments specific to their treatment group.
Participants will undergo a series of assessments that include self-report measures, medical
and psychological evaluations, and a physical capability evaluation by a physical trainer.
These assessments will be performed at recruitment, after the 8-week waiting period, after
treatment, at 1- and 3-month mail and telephone follow-ups, and at a 6-month follow-up in
the treatment clinic. They will assess fear, health, physical ability, and psychological
health.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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