This article is part of the Arthritis Archives.
Editor note: This study (NCT00057278) is no longer recruiting patients. Study start: March 2003; Study completion: March 2006; Last follow-up: January 2006; Data entry closure: March 2006
Dateline: May 7, 2003
Gabapentin In Fibromyalgia Trial (GIFT)
NIAMS, the National Institute of Arthritis and Musculoskeletal and Skin Diseases, is funding a study which will assess the effectiveness of gabapentin in reducing the symptoms of fibromyalgia syndrome. Gabapentin, which is the generic form of Neurontin, an anticonvulsant medication. The drug gabapentin has also been found to relieve chronic pain caused by nervous system disorders, and was most recently approved by the FDA for the treatment of persistent, severe pain associated with shingles.
Fibromyalgia is a chronic disorder with symptoms which include widespread musculoskeletal pain and fatigue. Treatment of fibromyalgia typically engages a comprehensive approach, combining:
Currently no medications are specifically approved by the FDA for the treatment of fibromyalgia. To treat the symptoms of fibromyalgia, many people are prescribed:
- nonsteroidal anti-inflammatory drugs (NSAIDS)
- muscle relaxants (muscle relaxers)
- other medicines that ease pain, promote sleep, or fight fatigue
Depending on the study results, gabapentin may become another treatment option for the estimated 3 to 6 million Americans affected by fibromyalgia. Mostly seen in women, fibromyalgia can affect children and men as well.
About The Study
The new study will be conducted by Lesley M. Arnold, M.D. and colleagues at the University of Cincinnati College of Medicine, and two Boston area sites, McLean Hospital of Harvard University and Newton-Wellesley Hospital. Approximately 150 study participants with fibromyalgia will be randomly assigned to take either gabapentin or a placebo for a 12-week period. The effectiveness of the medication will be evaluated using questionnaires that assess:
- quality of life
- tender point pain threshold
Tender points are specific places on the body, located on the neck, shoulders, back, hips, and upper and lower extremities, where people with fibromyalgia often feel pain in response to slight pressure.
Source:New Study to Test Anticonvulsant Medication for Fibromyalgia, NIAMS, April 2003
First published: 5/07/2003