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

NCT ID: NCT00795106

Last Updated: 2016-12-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-11-30

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.

Conditions

Myofascial Pain Syndrome

Keywords

Capsaicin; hydrogel; myofascial pain syndrome; neck pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Capsaicin patch

Patches will contain capsaicin 0.1% (500 mcg)

Group Type: ACTIVE_COMPARATOR

Capsaicin

Intervention Type: DRUG

Each group will undergo two 4-week treatment arms separated by a 4-week wash-out period. Participants will apply 1 hydrogel patch on both the right-sided and left-sided neck and shoulder girdle on the skin overlying a myofascial trigger point. No more than 2 patches will be used on each subject per treatment. During each 24-hour period, the patches will be placed on the skin for 12 hours and will be removed for 12 hours. Placebo hydrogel patches will be 2.5 cm in diameter with a breathable cloth backing. The experimental patches will be identical to placebo patches except will contain capsaicin 0.1% (500 mcg).

Placebo patch

Placebo hydrogel patches will be 2.5 cm in diameter with a breathable cloth backing.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Each group will undergo two 4-week treatment arms separated by a 4-week wash-out period. Participants will apply 1 hydrogel patch on both the right-sided and left-sided neck and shoulder girdle on the skin overlying a myofascial trigger point. No more than 2 patches will be used on each subject per treatment. During each 24-hour period, the patches will be placed on the skin for 12 hours and will be removed for 12 hours. Placebo hydrogel patches will be 2.5 cm in diameter with a breathable cloth backing. The experimental patches will be identical to placebo patches except will contain capsaicin 0.1% (500 mcg).

Interventions

Capsaicin

Each group will undergo two 4-week treatment arms separated by a 4-week wash-out period. Participants will apply 1 hydrogel patch on both the right-sided and left-sided neck and shoulder girdle on the skin overlying a myofascial trigger point. No more than 2 patches will be used on each subject per treatment. During each 24-hour period, the patches will be placed on the skin for 12 hours and will be removed for 12 hours. Placebo hydrogel patches will be 2.5 cm in diameter with a breathable cloth backing. The experimental patches will be identical to placebo patches except will contain capsaicin 0.1% (500 mcg).

Intervention Type: DRUG

Placebo

Each group will undergo two 4-week treatment arms separated by a 4-week wash-out period. Participants will apply 1 hydrogel patch on both the right-sided and left-sided neck and shoulder girdle on the skin overlying a myofascial trigger point. No more than 2 patches will be used on each subject per treatment. During each 24-hour period, the patches will be placed on the skin for 12 hours and will be removed for 12 hours. Placebo hydrogel patches will be 2.5 cm in diameter with a breathable cloth backing. The experimental patches will be identical to placebo patches except will contain capsaicin 0.1% (500 mcg).

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stamford Hospital

OTHER

Sponsor Role: lead

Responsible Party

Center for Integrative Medicine and Wellness at Stamford Hospital

Principal Investigators

Marc Brodsky, MD

Role: PRINCIPAL_INVESTIGATOR

Stamford Hospital

Locations

Stamford Hospital

Stamford, Connecticut, United States

Countries

United States

Other Identifiers

08-1014.01

Identifier Type: -

Identifier Source: org_study_id