Status:
COMPLETED
A Pilot Study on the Use of Nociceptive Flexion Reflex for Fibromyalgia
Lead Sponsor:
Indiana University
Conditions:
Fibromyalgia
Eligibility:
FEMALE
18-65 years
Phase:
PHASE4
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 li...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00965601
Start Date
July 1 2008
End Date
August 1 2009
Last Update
April 6 2012
Active Locations (1)
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1
National Institute of Fitness and Sport; IUPUI Campus
Indianapolis, Indiana, United States, 46202