Subgroups of Fibromyalgia Syndrome (FMS): Symptoms, Beliefs, and Tailored Treatment
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): CR+ST; ET; AC treatment
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Addresses maladaptive beliefs in general and includes education and training in the use of specific coping strategies; Addresses beliefs and emotional arousal during confrontations with feared element (exercising) through use of counter-conditioning and corrective feedback; Provides support and controls for nonspecific factors associated with exposure to therapists and other FMS sufferers, but does not directly address either maladaptive beliefs or emotional arousal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Fibromyalgia Syndrome; FMS; Physical Therapy; Psychotherapy; Group Counseling; Individual Counseling; Chronic Pain