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NCT00795106 | Withdrawn Phase 2 DMC

• 1 other identifier: 08-1014.01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Capsaicin; hydrogel; myofascial pain syndrome; neck pain

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale

  1 month

Secondary Outcomes (1)

• Quality of life

  1 month

Study Arms (2)

Capsaicin patch

ACTIVE COMPARATOR

Patches will contain capsaicin 0.1% (500 mcg)

Drug: Capsaicin

Placebo patch

PLACEBO COMPARATOR

Placebo hydrogel patches will be 2.5 cm in diameter with a breathable cloth backing.

Drug: Placebo

Interventions

Capsaicin DRUG

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).

Capsaicin patch

Placebo DRUG

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 patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults over 18 years of age
• Speak, read, and write English who have greater than 3 month duration of myofascial neck pain.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stamford Hospital: lead

Study Sites (1)

Stamford Hospital

Stamford, Connecticut, 06902, United States

Location

MeSH Terms

Conditions

Myofascial Pain Syndromes; Neck Pain

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Marc Brodsky, MD

  Stamford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 21, 2008
• Study Start: November 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: December 6, 2016

Record last verified: 2016-12

Locations

US (1)