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

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CR+ST
ET
AC treatment
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia Syndrome, FMS, Physical Therapy, Psychotherapy, Group Counseling, Individual Counseling, Chronic Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Sites / Locations

  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Cognitive restructuring and coping skills training (CR+ST)

Exposure therapy (ET)

Combination (COMB) treatment

Attention control (AC) treatment

Arm Description

Outcomes

Primary Outcome Measures

Oswestry Disability Index (ODI)

Secondary Outcome Measures

Full Information

First Posted
September 26, 2008
Last Updated
December 1, 2014
Sponsor
University of Washington
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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1. Study Identification

Unique Protocol Identification Number
NCT00762125
Brief Title
Subgroups of Fibromyalgia Syndrome (FMS): Symptoms, Beliefs, and Tailored Treatment
Official Title
Subgroups of Fibromyalgia Syndrome (FMS): Symptoms, Beliefs, and Tailored Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

5. Study Description

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.
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: 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. ET: This group will help participants to decrease their fear response during specific exercises through progressive, controlled exposure to the feared stimulus. 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia Syndrome, FMS, Physical Therapy, Psychotherapy, Group Counseling, Individual Counseling, Chronic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
266 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive restructuring and coping skills training (CR+ST)
Arm Type
Experimental
Arm Title
Exposure therapy (ET)
Arm Type
Experimental
Arm Title
Combination (COMB) treatment
Arm Type
Experimental
Arm Title
Attention control (AC) treatment
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
CR+ST
Intervention Description
Addresses maladaptive beliefs in general and includes education and training in the use of specific coping strategies
Intervention Type
Behavioral
Intervention Name(s)
ET
Intervention Description
Addresses beliefs and emotional arousal during confrontations with feared element (exercising) through use of counter-conditioning and corrective feedback
Intervention Type
Behavioral
Intervention Name(s)
AC treatment
Intervention Description
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
Primary Outcome Measure Information:
Title
Oswestry Disability Index (ODI)
Time Frame
Measured at the initial evaluation; after 8 weeks on a waiting list; immediately after treatment; and 1, 3, and 6 months after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet American College of Rheumatology (ACR) criteria for the diagnosis of fibromyalgia Able to comply with functional assessment and treadmill exercise Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis C. Turk, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98115
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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