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
| Status: | Withdrawn |
|---|---|
| Conditions: | Fibromyalgia, Psychiatric, Pain |
| Therapuetic Areas: | Musculoskeletal, Psychiatry / Psychology, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 12/7/2016 |
| Start Date: | November 2009 |
| End Date: | November 2010 |
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.
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.
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
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.
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