A Pilot Study of the Efficacy of Biofeedback in Patients With Fibromyalgia Syndrome.

Eighty female patients between the ages of 18 and 65 will be recruited from the rheumatology clinic at the University of Medicine and Dentistry of New Jersey - Robert Wood Johnson Medical School (UMDNJ-RWJMS). 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 will be included as subjects. 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. Patients will be required to add no medications to their regimen during the study period (approximately 5 to 7 months). Based on the clinical judgment of the investigators, patients may also be asked to withdraw from the study should they miss two or more consecutive biofeedback sessions.

After reading and signing the informed consent, all participants will receive a medical evaluation to confirm the diagnosis of FMS based on the criteria established by the American College of Rheumatology. All participants will be evaluated by board certified rheumatologists affiliated with UMDNJ-Robert Wood Johnson Medical School and remain blind to participants' group assignment. This examination will include a baseline tender point count or TPI that will be used as an exploratory measure. Next, participants will be asked to return for an appointment at the Biofeedback Laboratory at UMDNJ-RWJMS. Participants will be instructed to refrain from taking any caffeine or alcohol for twelve hours prior to this and all other sessions where physiologic measures are to be collected. Before beginning physiologic measures assessment, participants will complete the baseline outcome measures, the Fibromyalgia Impact Questionnaire (FIQ), the McGill Pain Questionnaire (MPQ), the Pittsburgh Sleep Quality Inventory (PSQI), and the Beck Depression Inventory II (BDI-II) in a quiet, private room.

The first appointment at the Biofeedback Laboratory will consist of introducing the participant to the setting, equipment and basic procedure of biofeedback. To obtain baseline physiological measures, we will take a 5-minute heart period recording and the other measures including blood pressure, respiration, and muscle tension. For consistency across participants on all resting 5-minute heart period recordings, a "vanilla" baseline task will be included. The "vanilla" baseline is a minimally demanding color detection task shown to provide a stable baseline against which changes in response to experimental challenges can be measured. The task involves the presentation of a 10 to 12 cm rectangle on a computer monitor that changes color every 10 seconds. Six colors are presented randomly and with equal probability over the course of the baseline period. Subjects are told beforehand to count the number of times the object changes back to a randomly determined initial color. At the end of the task subjects are asked to report their count.

All participants will also undergo a simple task for the assessment of orthostatic hypotension. Orthostatic hypotension is defined as a decrease of at least 20 mmHg in systolic blood pressure when an individual moves from a supine to standing position. This assessment will occur in the same lab where the biofeedback session occurs. First, both blood pressure and pulse will be recorded with the participant in a standing position. This will serve as the first recording of BP and pulse measures. Then, the participant will be instructed to lie down completely flat on a floor mat (supine position) for 10 minutes. Approximately three minutes after the participant goes from a supine to standing position, both blood pressure and pulse will be once again recorded. A stand-alone blood pressure device will be used to record these measures.

Next using biofeedback, all participants will be taught to breathe at their resonant frequency as described below. Based on the literature, we will consider the rate of breathing that produces the highest frequency peak to be the participant's "resonant frequency." Finding the true resonant frequency is a complex task beyond the scope and resources of this pilot project. Results from this analysis will advise matching participants on high frequency/low frequency rates.