A Pilot Study on the Use of Nociceptive Flexion Reflex for Fibromyalgia
Completed · Phase 4
Conditions studied: Fibromyalgia
In brief
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.
Key facts
- Study ID
- NCT00965601
- Run by
- Indiana University
- People needed
- 30
- Starts
- 2008-07-01
- Expected to finish
- 2009-08-01
- Last updated by the study team
- 2012-04-06
Who can join
Age: 18 and older, up to 65. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- National Institute of Fitness and Sport; IUPUI Campus — Indianapolis, Indiana, United States
Full record on ClinicalTrials.gov
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