Fibromyalgia Clinical Trial
— NFROfficial title:
A Pilot Study on the Use of Nociceptive Flexion Reflex for Fibromyalgia
Verified date | August 2009 |
Source | Indiana University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | August 2009 |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - 1. Female volunteers who have been diagnosed with fibromyalgia by a rheumatologist. - 2. Overall body pain average score = 4 - 3. Age range: 18 to 65 years old - 4. 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. - 5. Willingness to restrict any change (add or switch or change in the dose) of any fibromyalgia-related medication for 12 weeks. Exclusion Criteria: - 1. Volunteers who have long-standing history of diabetes (> 2 years), or have been diagnosed with any type of peripheral neuropathy. - 2. Have a prior history of myocardial infarction (heart attack) or unstable angina or other heart arrhythmias. - 3. Have been diagnosed with multiple sclerosis or any other demyelinating disorder. - 4. Have planned to undergo an elective surgery over the next 12 weeks. - 5. Have other major rheumatic conditions (i.e. rheumatoid arthritis, systemic lupus erythematosus, scleroderma and other connective tissue disease) - 6. Are currently pregnant or actively trying to become pregnant |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | National Institute of Fitness and Sport; IUPUI Campus | Indianapolis | Indiana |
Lead Sponsor | Collaborator |
---|---|
Indiana University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Aim 1: Test the feasibility and subject acceptability of a potentially objective tool (NFR) for measuring pain severity. | Baseline, Week 9, and Week 12 | No | |
Secondary | Aim 2: Determine the longitudinal relationships of changes in patients' symptoms with changes in plasma levels of neuropeptides and NFR pain threshold. | Baseline | No |
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