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NCT00222274 · ClinicalTrials.gov registry record · NA
HRV Biofeedback in Fibromyalgia
A NA study, sponsored by Rutgers, The State University of New Jersey.
- Completed
- Registry status
- NA
- Development phase
- 80
- Enrollment target
NCT00222274 is a NA study that has completed, run by Rutgers, The State University of New Jersey. The registered enrollment target is 80 participants.
The verdict
NCT00222274, a NA study, has completed, sponsored by Rutgers, The State University of New Jersey.
- COMPLETED
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
Study Summary
A growing body of evidence suggests that the symptoms of many fibromyalgia syndrome (FMS) sufferers might be the result of an imbalance in one of the major stress response systems, the autonomic nervous system. Thus respiratory sinus arrhythmia (RSA) biofeedback, which has shown promise in other conditions associated with an autonomic nervous system imbalance, could be effective in FMS. With the aid of sensors and computers, biofeedback involves modifying and/or learning how to control normally involuntary processes like blood pressure, heart rate and the autonomic nervous system through relaxation and breathing. The goal of this study is to test the effectiveness of a 10-session RSA biofeedback treatment for the symptoms of fibromyalgia. Forty patients receiving the RSA biofeedback treatment will be compared to 40 patients receiving another form of biofeedback thought to be minimally helpful (control group). Later, control group patients will also receive the RSA biofeedback treatment. We will study improvement in symptoms like pain, fatigue, sleep disturbance and depression in the RSA biofeedback group and compare these improvements to those in the control group. We will also assess whether these improvements persist over time and what if any changes in the autonomic nervous system result from the treatment.
Interventions
- BEHAVIORAL RSA Biofeedback
- BEHAVIORAL EEG Biofeedback Condition
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2004-07 |
| Est. Completion | 2011-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00222274
The ClinicalTrials.gov registry entry for NCT00222274 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 80 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Rutgers, The State University of New Jersey, which has 413 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which RSA Biofeedback is the first listed.
NCT00222274 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00222274 about?
NCT00222274 is a clinical study titled "HRV Biofeedback in Fibromyalgia". A growing body of evidence suggests that the symptoms of many fibromyalgia syndrome (FMS) sufferers might be the result of an imbalance in one of the major stress response systems, the autonomic nervous system. Thus respiratory sinus arrhythmia (RSA) biofeedback, which has shown promise in other con...
What is the current status of trial NCT00222274?
This trial is currently completed. It is a NA study. The enrollment target is 80 participants. The study started on 2004-07. Estimated completion is 2011-03.
What interventions are being tested in trial NCT00222274?
The interventions under investigation include: RSA Biofeedback (BEHAVIORAL), EEG Biofeedback Condition (BEHAVIORAL).
Who is sponsoring clinical trial NCT00222274?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
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