HRV Biofeedback in Fibromyalgia
Condition: Fibromyalgia Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome
Study type: Interventional

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.
    

Detailed description: 
      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.

      Group Assignment. Participants will then be randomly assigned to the active treatment group
      or EEG biofeedback control group using a restricted randomization procedure controlling for
      age, high frequency/low frequency rates, and general health status. Those assigned to the
      active treatment group will be given ten weekly training sessions in RSA biofeedback, while
      those in the control group will receive ten weekly sessions of EEG biofeedback starting
      immediately. All questionnaire and psychophysiological data collected at baseline will be
      repeated after the last training session 10 weeks later, and at 3 months. At the end of ten
      weeks, the EEG biofeedback control group participants will be offered the opportunity to
      participate in the 10-session RSA biofeedback program and subsequent intervention-related
      assessments (after the last biofeedback session (10th) and at (3 months). The Week 10
      assessment, taken at the conclusion of the EEG biofeedback treatment, will serve as the
      control group's baseline to maintain 10-week pretest/posttest consistency between groups. EEG
      biofeedback subjects will be compensated only once if they choose to participate in the RSA
      biofeedback trial.

      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.

      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. During the first session, we will measure heart rate
      oscillation amplitudes while the individual breathes for intervals of two minutes each at
      specific frequencies, ranging between 4 and 7 breaths per minute, respectively 4, 4.5, 5,
      5.5, 6, 6.5, and 7 breaths per minute. We will provide a "pacing stimulus" for this purpose:
      a light display that moves up and down on the computer screen at the target respiratory rate.
      The participant will be instructed to breathe at the rate of that stimulus. We will consider
      the frequency yielding the highest frequency peak on the moving Fourier analysis data
      collected and displayed by the C-2 physiograph to be the resonant frequency. In subsequent
      sessions, the individual will be given biofeedback for 20 minutes. The participant will be
      instructed to practice breathing at her own resonant frequency for 20-minute periods twice
      daily for the next week. Throughout training the individual will be cautioned to breathe
      shallowly and naturally, in order to avoid hyperventilation.

      At the second session, the participant will be directly given biofeedback for cardiac
      variability, and instructed to increase the amplitude of heart rate fluctuations that occur
      in conjunction with respiration. The feedback will be given in several forms. One is using a
      beat-to-beat cardiotachometer display, superimposed on a measure of respiratory activity
      taken from a strain gauge. The participant will be instructed to breathe approximately in
      phase with heart rate changes, with the goal of maximally increasing amplitude of RSA. In
      another display, the participant will be shown a moving frequency analysis of heart rate,
      within the band of .005-.4 Hz. The display will be updated approximately every second, and
      reflects the frequency of heart rate fluctuations within the past 30 seconds. The participant
      will be instructed to increase the spectral power peak that occurred at approximately
      resonant frequency. At the beginning and end of this and every biofeedback session
      participants will be asked to rate their pain, muscle stiffness, fatigue, mood and cognitive
      processes (memory and concentration) on a verbal scale of one to ten.

      In the third session, a stand-alone device will be provided for home practice HeartMath
      Freeze Framer. This system analyzes heart rhythms and provides a display sensitive to
      changes. A colorful game format is used to reward the user for increases in heart rate
      coherence, which in turn will maximize amplitude of RSA. Participants will be instructed to
      practice for two 20-minute sessions per day and note in the log included with the HeartMath
      Freeze Framer instructions whether or not they practiced each day, the length of each
      practice session, and any questions or observations.

      Biofeedback Data Collection Procedure. At sessions 1, 10, and at 3 months, a resting 5-minute
      heart period using the "vanilla" task will be obtained before commencing biofeedback and at
      the end of the session. During biofeedback, two 5-minute heart period recordings will be
      taken, one at the beginning of the session and one at the end. Questionnaire data will then
      be collected. Patients will be given a $25 payment for participation at the end of each data
      collection session for a total of $75.
    

Intervention name(s): RSA Biofeedback; EEG Biofeedback Condition
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: fibromyalgia; pain; biofeedback; heart rate variability