NCT00088777

Brief Summary

Fibromyalgia (FM) syndrome is a common chronic pain disorder that may benefit from nondrug treatment. This study will compare the effectiveness of behavioral preparation, stress management education, and fibromyalgia and coping education in relieving the symptoms of FM. Each of these nondrug treatments will be combined with physical therapy and physical education. Specific aims: 1) Evaluate the efficacy of behavioral preparation programs on attrition, compliance, and treatment outcomes of self-management rehabilitation for FM syndrome. 2) Determine factors that mediate clinical efficacy. 3) Evaluate individual differences in treatment responses to delineate who will benefit most from each type of the behavioral preparation programs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2004

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2005

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

August 12, 2011

Status Verified

August 1, 2011

Enrollment Period

5.2 years

First QC Date

August 4, 2004

Last Update Submit

August 10, 2011

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Major FM syndrome symptoms immediately following treatment and at 6- and 12-month follow-up evaluations

    post-treatment, 6 month and 12 month follow-ups

Study Arms (2)

MET

EXPERIMENTAL
Behavioral: Behavioral coping skills training plus physical therapy

CSE

EXPERIMENTAL
Behavioral: Stress management education plus physical therapy

Interventions

Behavioral coping skills training plus physical therapyBEHAVIORAL

10 hours coping sessions, 6 hours activating physical therapy, 4 hours physical therapy education

MET
Stress management education plus physical therapyBEHAVIORAL

10 hours stress management education, 6 hours activating physical therapy, 4 hours physical therapy education

CSE

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of fibromyalgia
  • Have not been actively exercising (e.g., aerobic activity such as cycling, jogging, climbing, rowing, and muscle strengthening activity) for more than 30 minutes per week

You may not qualify if:

  • Other progressive disease
  • Plan to have surgery during the next year
  • Pregnancy or planning to become pregnant during the next year
  • Resting diastolic blood pressure greater than 115 mm Hg or resting systolic blood pressure greater than 200 mg Hg
  • Cardiovascular diseases
  • Serious psychopathology (e.g., diagnoses of psychosis, organic mental disorder, or dissociative disorder; active suicidal intent; inpatient admission to psychiatric ward or incidence of self-injurious behaviors in the past year)
  • Non-IV substance abuse within the last 2 years, or history of recreational IV drug use
  • Other rheumatologic disorder (e.g., rheumatoid arthritis)
  • Neuropathic pain
  • Pain associated with terminal illness, acute pain, or pain associated with specific organ damage (e.g., stomach ulcer)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah, Pain Research and Management Center

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Officials

  • Akiko Okifuji, PhD

    University of Utah, Pain Research and Management Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 4, 2004

First Posted

August 5, 2004

Study Start

January 1, 2005

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

August 12, 2011

Record last verified: 2011-08

Locations

US(1)