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

Phase 2

Withdrawn

• Conditions: Myofascial Pain Syndrome
• Interventions: Drug: Placebo; Drug: Capsaicin

• Registration Number: NCT00795106
• Lead Sponsor: Stamford Hospital

Brief 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.

Detailed 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 Timeline

• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Study Start: 2009-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Status Verified: 2016-12
• Last Update Submitted: 2016-12-05
• Last Update Posted: 2016-12-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Adults over 18 years of age
• Speak, read, and write English who have greater than 3 month duration of myofascial neck pain.

Exclusion Criteria

• Patients who have used capsaicin in the last 4 months and patients with allergy to capsaicin
• Rash/infection overlying neck and shoulder girdle area
• Radiculopathy or structural abnormalities in the area being treated
• Unstable underlying diseases such as cardiovascular, hepatic, renal and CNS disorders will be excluded from the study
• Pregnant or breast-feeding women will not be allowed to participate in the study, and women of child bearing age will be using an effective method of birth control.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo patch	Placebo	Placebo hydrogel patches will be 2.5 cm in diameter with a breathable cloth backing.
Capsaicin patch	Capsaicin	Patches will contain capsaicin 0.1% (500 mcg)

Primary Outcome Measures

Name	Time	Method
Visual analogue scale	1 month

Secondary Outcome Measures

Name	Time	Method
Quality of life	1 month

Trial Locations

Locations (1)

Stamford Hospital; 🇺🇸 Stamford, Connecticut, United States