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NCT00000398 · ClinicalTrials.gov registry record · Phase 2

Behavioral Treatment of Fibromyalgia

A Phase 2 study, sponsored by Ohio University.

Completed
Registry status
Phase 2
Development phase
180
Enrollment target

NCT00000398: Completed Phase 2 study, sponsored by Ohio University.

NCT00000398 is a Phase 2 study that has completed, run by Ohio University. The registered enrollment target is 180 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00000398, a Phase 2 study, has completed, sponsored by Ohio University.

COMPLETED
Registry status
Phase 2
Development phase
180 participants
Enrollment target

Study Summary

Fibromyalgia (FM) is one of the most common rheumatic diseases (conditions or disorders that cause pain or stiffness in the joints, muscles, or bones). It affects 6 million Americans and up to 20 percent of patients seen by doctors who specialize in treating rheumatic diseases. This study will evaluate the effects of two of the most promising nondrug treatments for FM: coping skills training and physical exercise training. We will randomly assign each of 180 patients diagnosed with FM to one of four groups: coping skills training (CST), physical exercise training alone, CST plus physical exercise training, or a waiting list (nontreatment group). We will look at the separate and combined effects of CST and physical exercise training and evaluate how changes in aerobic fitness, self-effectiveness (a person's belief in his or her ability to reach a goal, such as managing one's own disease), and negative pain-related thoughts relate to improvements in pain and disability.

Interventions

  • BEHAVIORAL Coping skills training
  • BEHAVIORAL Physical exercise training
  • BEHAVIORAL Coping skills training plus physical exercise training

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 1996-07
Est. Completion 2000-06
Phase Phase 2
Ohio University

51 total trials

What the finished NCT00000398 record still lists

NCT00000398 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% higher).

The record links to 0 conditions, and to 3 interventions - of which Coping skills training is the first listed.

NCT00000398 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00000398 about?

NCT00000398 is a clinical study titled "Behavioral Treatment of Fibromyalgia". Fibromyalgia (FM) is one of the most common rheumatic diseases (conditions or disorders that cause pain or stiffness in the joints, muscles, or bones). It affects 6 million Americans and up to 20 percent of patients seen by doctors who specialize in treating rheumatic diseases. This study will evalu...

What is the current status of trial NCT00000398?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 1996-07. Estimated completion is 2000-06.

What interventions are being tested in trial NCT00000398?

The interventions under investigation include: Coping skills training (BEHAVIORAL), Physical exercise training (BEHAVIORAL), Coping skills training plus physical exercise training (BEHAVIORAL).

Who is sponsoring clinical trial NCT00000398?

This trial is sponsored by Ohio University, which has 51 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00000398's enrollment target sits among peer trials

180 365th of 2000 higher than 1,610 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00000398, the US trial registry maintained by the National Library of Medicine. NCT00000398 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.