Clinical Trial: A Pilot Study on the Use of Nociceptive Flexion Reflex for Fibromyalgia
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Pilot Study on the Use of Nociceptive Flexion Reflex for Fibromyalgia
Brief 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 Summary:
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:
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Sponsor: Indiana University
Current Primary Outcome: Aim 1: Test the feasibility and subject acceptability of a potentially objective tool (NFR) for measuring pain severity. [ Time Frame: Baseline, Week 9, and Week 12 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Aim 2: Determine the longitudinal relationships of changes in patients' symptoms with changes in plasma levels of neuropeptides and NFR pain threshold. [ Time Frame: Baseline ]
Original Secondary Outcome: Same as current
Information By: Indiana University
Dates:
Date Received: August 24, 2009
Date Started: July 2008
Date Completion:
Last Updated: April 5, 2012
Last Verified: August 2009
