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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

Information source: Stamford Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Myofascial Pain Syndrome

Intervention: Capsaicin (Drug); Placebo (Drug)

Phase: Phase 2

Status: Withdrawn

Sponsored by: Stamford Hospital

Official(s) and/or principal investigator(s):
Marc Brodsky, MD, Principal Investigator, Affiliation: Stamford Hospital

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 Details

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

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

Primary outcome: Visual analogue scale

Secondary outcome: Quality of life

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Stamford Hospital, Stamford, Connecticut 06902, United States
Additional Information

Starting date: November 2009
Last updated: December 13, 2012

Page last updated: August 20, 2015

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