Subgroups of Fibromyalgia Syndrome (FMS): Symptoms, Beliefs, and Tailored Treatment

NCT00762125 | Completed Phase 2

• 1 other identifier: R01AR044724-07
• Study Type: interventional
• Target: 266
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fibromyalgia

Keywords

Fibromyalgia Syndrome; FMS; Physical Therapy; Psychotherapy; Group Counseling; Individual Counseling; Chronic Pain

Outcome Measures

Primary Outcomes (1)

• Oswestry Disability Index (ODI)

  Measured at the initial evaluation; after 8 weeks on a waiting list; immediately after treatment; and 1, 3, and 6 months after treatment

Study Arms (4)

Cognitive restructuring and coping skills training (CR+ST)

EXPERIMENTAL

Behavioral: CR+ST

Exposure therapy (ET)

EXPERIMENTAL

Behavioral: ET

Combination (COMB) treatment

EXPERIMENTAL

Behavioral: CR+ST; Behavioral: ET

Attention control (AC) treatment

ACTIVE COMPARATOR

Behavioral: AC treatment

Interventions

CR+ST BEHAVIORAL

Addresses maladaptive beliefs in general and includes education and training in the use of specific coping strategies

Cognitive restructuring and coping skills training (CR+ST); Combination (COMB) treatment

ET BEHAVIORAL

Addresses beliefs and emotional arousal during confrontations with feared element (exercising) through use of counter-conditioning and corrective feedback

Combination (COMB) treatment; Exposure therapy (ET)

AC treatment BEHAVIORAL

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

Attention control (AC) treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Meet American College of Rheumatology (ACR) criteria for the diagnosis of fibromyalgia
• Able to comply with functional assessment and treadmill exercise

You may not qualify if:

• History of psychiatric hospitalization, suicide attempt, or significant problems with chemical dependency during the 6 months prior to enrollment in the study
• Evidence of severe psychiatric disorder that would prevent participation
• Medical conditions, such as significant cardiac disease, that make it medically unsuitable for participation in a progressive exercise program
• A medical condition, such as multiple sclerosis, that has a high likelihood of obscuring effects of the experimental treatments
• Anxiety or mood disorders in which symptoms are severe enough to prevent participation

Sponsors & Collaborators

• University of Washington: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Washington

Seattle, Washington, 98115, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Chronic Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dennis C. Turk, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: December 1, 2005
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: December 2, 2014

Record last verified: 2014-12

Locations

US (1)