HRV Biofeedback in Fibromyalgia

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Fibromyalgia Syndrome	Behavioral: RSA Biofeedback; Behavioral: EEG Biofeedback Condition	Not Applicable

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	80 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
Primary Purpose:	Treatment
Official Title:	A Pilot Study of the Efficacy of Biofeedback in Patients With Fibromyalgia Syndrome.
Study Start Date :	July 2004
Actual Primary Completion Date :	March 2011
Actual Study Completion Date :	March 2011

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1; RSA Biofeedback: RSA Biofeedback Condition. The biofeedback will consist of 10 weekly sessions of training, at the same time of day for each subject. The details of the procedure for RSA biofeedback are described in Appendix A. One single practitioner, a certified biofeedback technician, will provide the biofeedback following the aforementioned protocol. In each session, 20 minutes of biofeedback will be delivered using a J&J C-2+ Physiograph. The participant will be taught to breathe at her resonant frequency, as a first step to training the individual how to produce maximal increases in amplitude of RSA.	Behavioral: RSA Biofeedback; RSA Biofeedback Condition. The biofeedback will consist of 10 weekly sessions of training, at the same time of day for each subject. The details of the procedure for RSA biofeedback are described in Appendix A. One single practitioner, a certified biofeedback technician, will provide the biofeedback following the aforementioned protocol. In each session, 20 minutes of biofeedback will be delivered using a J&J C-2+ Physiograph. The participant will be taught to breathe at her resonant frequency, as a first step to training the individual how to produce maximal increases in amplitude of RSA.
Active Comparator: 2; EEG Biofeedback Condition. Participants assigned to this condition will receive 10 sessions of EEG alpha biofeedback. In each session, 20 minutes of biofeedback will be delivered using a J&J I-330-C2+ physiograph. The participant will learn how to modify specific brainwave activity known as alpha. In particular, participants will be taught to increase amplitude of alpha in the range of 8-12 Hz. Increased amplitude is this range is associated with relaxation and reduction of anxiety, but not baroreflex gain. Participants will also practice for two 20-minute periods daily using the same methods used to increase alpha found in lab sessions.	Behavioral: EEG Biofeedback Condition; EEG Biofeedback Condition. Participants assigned to this condition will receive 10 sessions of EEG alpha biofeedback. In each session, 20 minutes of biofeedback will be delivered using a J&J I-330-C2+ physiograph. The participant will learn how to modify specific brainwave activity known as alpha. In particular, participants will be taught to increase amplitude of alpha in the range of 8-12 Hz. Increased amplitude is this range is associated with relaxation and reduction of anxiety, but not baroreflex gain. Participants will also practice for two 20-minute periods daily using the same methods used to increase alpha found in lab sessions.

Outcome Measures

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Primary Outcome Measures :

1. Global functioning [ Time Frame: 10 weeks ]

Secondary Outcome Measures :

1. Pain [ Time Frame: 10 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• Qualified participants are those who have a diagnosis of FMS from a board certified rheumatologist using the diagnostic criteria established by the American College of Rheumatology. Because women account for over 85% of FMS patients only women between the ages of 18 and 65 will be included as subjects

Exclusion Criteria:

• Excluded from participating will be women with any of the following medical conditions: neurologic disease or brain injury, stroke or cardiovascular disease, serious pulmonary disease including asthma, liver or kidney disease, serious gastrointestinal disorders, and major psychiatric conditions including psychoses, bipolar disorder, alcohol or drug abuse, and eating disorders. Also excluded will be women with a life threatening medical illness, communicative disorder, lack of fluency in English, illiteracy, cardiac arrhythmia or high frequency and low frequency waves that are indistinguishable or that interact.

Contacts and Locations

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Locations

United States, New Jersey
UMDNJ-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903

Sponsors and Collaborators

Rutgers, The State University of New Jersey

Arthritis Foundation

Investigators

Principal Investigator:	Afton L Hassett, Psy.D.	Rutgers, The State University of New Jersey

More Information

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Responsible Party:	Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:	NCT00222274 History of Changes
Other Study ID Numbers:	4145
First Posted:	September 22, 2005
Last Update Posted:	February 9, 2015
Last Verified:	February 2015

Keywords provided by Rutgers, The State University of New Jersey:

fibromyalgia; pain; biofeedback; heart rate variability

Additional relevant MeSH terms:

Syndrome; Fibromyalgia; Myofascial Pain Syndromes; Disease; Pathologic Processes	Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases