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

Conditions:Fibromyalgia, Psychiatric, Pain
Therapuetic Areas:Musculoskeletal, Psychiatry / Psychology, Rheumatology
Age Range:18 - Any
Start Date:November 2009
End Date:November 2010

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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

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.

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.

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

- 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.
We found this trial at
Stamford, Connecticut 06904
Stamford, CT
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