A Pilot Study on the Use of Nociceptive Flexion Reflex for Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators are doing this study to better understand the role of the central nervous
      system in processing painful stimuli in patients with fibromyalgia. Specifically, the
      investigators would like to know whether the central nervous system processing of painful
      stimuli changes with time and with talk therapy. In addition, the investigators are
      investigating how changes in your fibromyalgia symptoms may affect certain markers or
      proteins in your blood.
    

Detailed description: 
      Overall Design

      Female patients with FM will be enrolled in this 12-week prospective cohort study. To effect
      change in patient's symptoms, subjects (n=30) will be randomized to receive six sessions of
      phone-based cognitive behavioral therapy (CBT) or to 'usual' care. CBT will be provided from
      week 1 (baseline) to week 6. Outcome assessments (i.e., self-report symptom questionnaires,
      plasma neuropeptide levels and NFR) will be performed at baseline, week 6 and week 12.
      Subjects who not complete all three testing phases of the study will be reported as
      withdraws, and will be replaced as needed until a total of 30 volunteers have completed this
      study:

      Volunteers will be asked to visit the Fibromyalgia Clinical Research Center on 3 different
      occasions: baseline (Screening), week 6, and week 12.

      During the first visit subjects will be randomly assigned to one of two groups. Similar to
      flipping a coin, you have a 50% chance of being assigned to either one of two groups: a)
      telephone-based educational instruction group or b) usual care group. Subjects who are
      randomly assigned to educational instruction group will receive one phone call per week for
      the first six weeks of the study. During the phone conversation, you will receive
      instructions in managing your pain. If subjects are assigned to the educational instruction
      group, subjects must agree to allow us to audiotape the telephone conversation. Audio-taping
      the telephone conversations will help us give you the highest quality of instruction. On the
      other hand, subjects assigned to the usual care group will receive no telephone calls from
      the research team.

      During each visit subjects will be asked to do the following:

        1. Complete a comprehensive questionnaire (computer-based or the traditional paper and pen
           format) in regard to how fibromyalgia affects your daily living.

           Risks: You may feel uncomfortable or care not to answer a particular question. To
           minimize these risks, you can tell the researcher that you feel uncomfortable or do not
           wish to answer the question.

        2. Provide a blood sample (10 ml).The purpose or this blood test is to examine changes in
           certain blood markers in relation to your changes in your symptoms

           Risks: The physical risks associated with participation in this study are with the blood
           draw. The process of drawing blood may cause bleeding, bruising, pain, lightheadedness,
           and some minor swelling around the area of the needle stick. Occasionally an infection
           or bleeding may develop where the needle was placed in the vein. To minimize these
           risks, the blood specimen will be obtained by experienced technicians.

        3. Undergo nociceptive flexion reflex (NFR) testing. This test examines how your body
           responds to painful stimuli. To begin each testing session, electrodes used to measure
           the nociceptive flexion reflex will be attached to your left leg. To measure the reflex,
           we will administer a series of electrical stimuli to the ankle of your left foot. After
           each stimulus you will be asked to rate the stimulus intensity using a scale with
           anchors of 0 (no sensation), 50 (pain threshold), and 100 (maximum tolerable). This
           procedure is used to determine the intensity of stimulus required to elicit a
           nociceptive flexion reflex response from your left hamstring muscle. This reflex is so
           small that you may not even notice any activity in your leg muscles. The intensity of
           electrical stimuli will be increased slowly until a reflex response is shown, but the
           intensity will NEVER exceed that which you rate as a "100" (maximum tolerable). At the
           higher intensities, the electrical stimulus is described by others as feeling like a
           "brief pinprick" or "carpet shock".

      We will use the same procedure to assess your pain tolerance threshold for electrical
      stimulation to your ankle. Stimulus intensity will be increased slowly and you will be asked
      to rate each stimulus on the 0-100 scale. The procedure will end as soon as you provide a
      stimulus intensity rating of "100" (maximum tolerable).

      Risks: The nociceptive flexion reflex procedure is likely to elicit temporary discomfort,
      increases in heart rate and blood pressure as well as sensations of discomfort or pain.
      Further, preparation of the skin required to apply electrodes may be mildly irritating or
      uncomfortable, and may leave behind some redness of the skin that could require a few days to
      heal. To minimize these risks, only well trained technicians will conduct this test. It is
      important to note that this test is similar to an EMG (electromyogram) study - a test
      commonly done in routine medical care.
    

Intervention name(s): Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): Subjects randomized to the Active Arm will receive workbook assignments a series of six phone intervention interviews of Cognitive Behavioral Therapy (CBT)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Fibromyalgia