Completed

Behavioral Treatment of Fibromyalgia

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Coping skills training

+ Physical exercise training

+ Coping skills training plus physical exercise training

Behavioral
Who is being recruted

Muscular Diseases+7

+ Musculoskeletal Diseases

+ Nervous System Diseases

Over 21 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: July 1996
See protocol details

Summary

Principal SponsorOhio University
Last updated: November 27, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: July 1, 1996

Actual date on which the first participant was enrolled.

Fibromyalgia (FM) is characterized by diffuse musculoskeletal pain, discrete tender points at typical soft-tissue sites, fatigue, stiffness, and sleep problems. Of these symptoms, pain is often the primary concern of FM patients and their physicians. Traditional medical approaches to managing FM have limitations (side effects) and have not been effective in managing pain. Given these limitations, treatments that involve nonpharmacologic interventions may represent a valuable addition to patient care. This study will evaluate the effects of two of the most promising nonpharmacologic interventions for FM: coping skills training (CST) for pain management and physical exercise training. The study is designed to test the hypothesis that an intervention that combines CST and physical exercise training will be more effective than CST or exercise alone. In this study, we will randomly assign each of 180 patients diagnosed with FM to one of four conditions: CST alone, physical exercise training alone, CST plus physical exercise training, or a waiting list control. We will evaluate study participants on four occasions: pre-treatment, post-treatment, 3-month followup, and 6-month followup. The study will look at the separate and combined effects of CST and physical exercise training and evaluate how changes in aerobic fitness, self-effectiveness, and negative pain-related thoughts relate to improvements in pain and disability. Physicians could use this information in matching FM patients to treatment interventions. In addition, our findings may have implications for treatment selection for a broad range of patients suffering from persistent pain.

NCT00000398
Principal SponsorOhio University
Last updated: November 27, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

180 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 21 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Muscular DiseasesMusculoskeletal DiseasesNervous System DiseasesNeurologic ManifestationsNeuromuscular DiseasesRheumatic DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsFibromyalgiaPain

Criteria

2 inclusion criteria required to participate
Complaints of pain persisting for 6 months

Meet diagnostic criteria for fibromyalgia (American College of Rheumatology criteria)

4 exclusion criteria prevent from participating
A significant adverse medical condition that would expose the individual to increased risk of an adverse experience during the course of the trial (e.g. a recent ( < 6 months) myocardial infarction)

An abnormal cardiac response to exercise

Other significant rheumatic disease

Receiving or applying for disability or compensation benefits because of fibromyalgia

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Ohio University

Athens, United StatesOpen Ohio University in Google Maps

Ohio State University

Columbus, United States
Completed2 Study Centers