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Trial to Evaluate the Efficacy of Topical Capsaicin to Reduce Pain and Improve Health-related Quality of Life in Adults With Chronic Myofascial Neck Pain

Myofascial Pain Syndrome Clinical Trial

Official title:
Double-blinded, Cross-over Randomized Controlled Trial to Evaluate the Efficacy of Topical Capsaicin to Reduce Pain and Improve Health-related Quality of Life in Adults With Chronic Myofascial Neck Pain

Clinical Trial Summary

Chronic neck pain is a common condition that can negatively impact quality of life. Substance P is one of the chemicals in the body that can transmit pain signals from overloaded neck muscles to the brain. Topical capsaicin blocks the action of Substance P by releasing, and subsequently depleting the body's store of Substance P in the nerves. Topical capsaicin has been reported to be an effective therapy for a number of persistent pain conditions including diabetic neuropathy, post-herpetic neuralgia, osteoarthritis, rheumatoid arthritis, and post-mastectomy pain. This study will evaluate the efficacy of topical capsaicin to reduce pain and improve health-related quality of life in adults with chronic muscular neck pain.

Clinical Trial Description

The study will employ a double blinded randomized controlled cross-over trial design. A total of 60 patients aged 18-65 with at least 3 months of myofascial neck pain will be recruited to participate in the study. The participants will be randomized into two groups. Each group will undergo two 4-week treatment arms separated by a 4-week wash-out period. Participants will apply a topical gel patch 12 hours each day overlying painful areas in the neck and shoulder girdle for each 4-week period. The topical gel patch used in each arm of the study will be identical except the placebo will not contain the active ingredient, 0.1% capsaicin. Both topical gel patches will be supplied by Caleb Pharmaceuticals. Each participant will complete 3 surveys at baseline and after each 4-week treatment arm: 1) McGill Pain Scale, 2) visual analog scale, and 3) Short Form 36 (general quality of life data). Paired T-tests will be used to evaluate for statistically significant changes between treatment with the control gel versus the active ingredient gel containing the capsaicin. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00795106
Study type Interventional
Source Stamford Hospital
Contact
Status Withdrawn
Phase Phase 2
Start date November 2009
Completion date November 2010
View Details
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