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

This study has been withdrawn prior to enrollment.
(Difficulty finding a monitor)
Sponsor:
Information provided by:
Stamford Hospital
ClinicalTrials.gov Identifier:
NCT00795106
First received: November 20, 2008
Last updated: December 13, 2012
Last verified: September 2009
  Purpose

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.


Condition Intervention Phase
Myofascial Pain Syndrome
Drug: Capsaicin
Drug: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Stamford Hospital:

Primary Outcome Measures:
  • Visual analogue scale [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: November 2009
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Capsaicin patch
Patches will contain capsaicin 0.1% (500 mcg)
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).
Placebo Comparator: Placebo patch
Placebo hydrogel patches will be 2.5 cm in diameter with a breathable cloth backing.
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).

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795106

Locations
United States, Connecticut
Stamford Hospital
Stamford, Connecticut, United States, 06902
Sponsors and Collaborators
Stamford Hospital
Investigators
Principal Investigator: Marc Brodsky, MD Stamford Hospital
  More Information

No publications provided

Responsible Party: Marc Brodsky, Medical Director, Center for Integrative Medicine and Wellness at Stamford Hospital
ClinicalTrials.gov Identifier: NCT00795106     History of Changes
Other Study ID Numbers: 08-1014.01
Study First Received: November 20, 2008
Last Updated: December 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Stamford Hospital:
Capsaicin
hydrogel
myofascial pain syndrome
neck pain

Additional relevant MeSH terms:
Neck Pain
Myofascial Pain Syndromes
Fibromyalgia
Somatoform Disorders
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Mental Disorders
Capsaicin
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014