MedTrace Logo

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

NCT00795106 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2016-12-06

No results posted yet for this study

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.

Conditions

  • Myofascial Pain Syndrome

Interventions

DRUG

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).

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).

Sponsors & Collaborators

  • Stamford Hospital

    lead OTHER

Principal Investigators

  • Marc Brodsky, MD · Stamford Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00795106 on ClinicalTrials.gov