HRV Biofeedback in Fibromyalgia

NCT00222274 | Completed

• 1 other identifier: 4145
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia Syndrome

Keywords

fibromyalgia; pain; biofeedback; heart rate variability

Outcome Measures

Primary Outcomes (1)

• Global functioning

  10 weeks

Secondary Outcomes (1)

• Pain

  10 weeks

Study Arms (2)

1

EXPERIMENTAL

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

2

ACTIVE COMPARATOR

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

Interventions

RSA Biofeedback BEHAVIORAL

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.

1

EEG Biofeedback Condition BEHAVIORAL

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.

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• Arthritis Foundation: collaborator

Study Sites (1)

UMDNJ-Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Afton L Hassett, Psy.D.

  Rutgers, The State University of New Jersey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2005
• First Posted: September 22, 2005
• Study Start: July 1, 2004
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: February 9, 2015

Record last verified: 2015-02

Locations

US (1)