HRV Biofeedback in Fibromyalgia

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2008 by Rutgers, The State University of New Jersey.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Arthritis Foundation
Information provided by:
Rutgers, The State University of New Jersey
ClinicalTrials.gov Identifier:
NCT00222274
First received: September 15, 2005
Last updated: June 25, 2008
Last verified: June 2008
  Purpose

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 Intervention
Fibromyalgia Syndrome
Behavioral: RSA Biofeedback
Behavioral: EEG Biofeedback Condition

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Efficacy of Biofeedback in Patients With Fibromyalgia Syndrome.

Resource links provided by NLM:


Further study details as provided by Rutgers, The State University of New Jersey:

Primary Outcome Measures:
  • Global functioning [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: July 2004
Estimated Study Completion Date: September 2008
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00222274

Locations
United States, New Jersey
UMDNJ-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Sponsors and Collaborators
University of Medicine and Dentistry New Jersey
Arthritis Foundation
Investigators
Principal Investigator: Afton L Hassett, Psy.D. Rutgers, The State University of New Jersey
  More Information

No publications provided

Responsible Party: Afton L. Hassett, Psy.D., UMDNJ-Robert Wood Johnson Medical School
ClinicalTrials.gov Identifier: NCT00222274     History of Changes
Other Study ID Numbers: 4145
Study First Received: September 15, 2005
Last Updated: June 25, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Rutgers, The State University of New Jersey:
fibromyalgia
pain
biofeedback
heart rate variability

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on April 21, 2014