HRV Biofeedback in Fibromyalgia
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00222274 |
Recruitment Status :
Completed
First Posted : September 22, 2005
Last Update Posted : February 9, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Fibromyalgia Syndrome | Behavioral: RSA Biofeedback Behavioral: EEG Biofeedback Condition | Not Applicable |

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 |

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. |
- Global functioning [ Time Frame: 10 weeks ]
- Pain [ Time Frame: 10 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00222274
United States, New Jersey | |
UMDNJ-Robert Wood Johnson Medical School | |
New Brunswick, New Jersey, United States, 08903 |
Principal Investigator: | Afton L Hassett, Psy.D. | Rutgers, The State University of New Jersey |
Responsible Party: | Rutgers, The State University of New Jersey |
ClinicalTrials.gov Identifier: | NCT00222274 |
Other Study ID Numbers: |
4145 |
First Posted: | September 22, 2005 Key Record Dates |
Last Update Posted: | February 9, 2015 |
Last Verified: | February 2015 |
fibromyalgia pain biofeedback heart rate variability |
Fibromyalgia Myofascial Pain Syndromes Syndrome Disease Pathologic Processes |
Muscular Diseases Musculoskeletal Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases |