A Pilot Study on the Use of Nociceptive Flexion Reflex for Fibromyalgia
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Indiana University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Aim 1: Test the feasibility and subject acceptability of a potentially objective tool (NFR) for measuring pain severity.
Study Overview
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 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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female volunteers who have been diagnosed with fibromyalgia by a rheumatologist.
- •Overall body pain average score ≥ 4
- •Age range: 18 to 65 years old
- •You must be on stable doses of anyone of these fibromyalgia-related medications for at least 4 weeks: cyclobenzaprine, tramadol, gabapentin, pregabalin, amitriptyline, nortriptyline, trazodone, sertraline, fluoxetine, paxil, remeron, venlafaxine and duloxetine.
- •Willingness to restrict any change (add or switch or change in the dose) of any fibromyalgia-related medication for 12 weeks.
Exclusion Criteria
- •Volunteers who have long-standing history of diabetes (> 2 years), or have been diagnosed with any type of peripheral neuropathy.
- •Have a prior history of myocardial infarction (heart attack) or unstable angina or other heart arrhythmias.
- •Have been diagnosed with multiple sclerosis or any other demyelinating disorder.
- •Have planned to undergo an elective surgery over the next 12 weeks.
- •Have other major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and other connective tissue disease)
- •Are currently pregnant or actively trying to become pregnant
Arms & Interventions
CTB Group
Subjects will receive workbook assignments a series of six phone intervention interviews of Cognitive Behavioral Therapy (CBT)
Intervention: Cognitive Behavioral Therapy (Behavioral)
Usual Care
Subjects will not receive any type of intervention
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Aim 2: Determine the longitudinal relationships of changes in patients' symptoms with changes in plasma levels of neuropeptides and NFR pain threshold.(Baseline)