Evaluating Therapeutic Massage for Chronic Neck Pain

Purpose

This study will provide the basis for a full-scale trial to evaluate the effectiveness and safety of therapeutic massage for chronic neck pain (CNP). The study will involve two phases: Phase I includes the development of massage and control protocols and the development of appropriate inclusion and exclusion criteria. Phase II is a pilot trial to evaluate the safety and efficacy of massage for CNP using the study components developed in Phase I. The effect of massage will be evaluated by comparing the changes in symptoms, function, and quality of life in massage and self care groups midway through treatment, at the end of treatment and at 6 months post randomization.

Purpose This study will provide the basis for a full-scale trial to evaluate the effectiveness and safety of therapeutic massage for chronic neck pain (CNP). The study will involve two phases: Phase I includes the development of massage and control protocols and the development of appropriate inclusion and exclusion criteria. Phase II is a pilot trial to evaluate the safety and efficacy of massage for CNP using the study components developed in Phase I. The effect of massage will be evaluated by comparing the changes in symptoms, function, and quality of life in massage and self care groups midway through treatment, at the end of treatment and at 6 months post randomization. Condition: – Neck Pain- Cervicalgia Study Type: InterventionalStudy Design: Treatment, Randomized, Placebo Control, Parallel Assignment, Safety/Efficacy Study Further Study Details: Neck pain is one of the most common problems affecting the health of Americans and is a leading reason for using complementary or alternative medical (CAM) therapies. Therapeutic massage is one of the most popular CAM treatments for neck pain, but little is known about its effectiveness. This study will lay the groundwork for a full-scale trial that evaluates the effectiveness of therapeutic massage for chronic neck pain. During Phase I of this project, we will develop and pre-test key components for such a randomized clinical trial. This will include specification of protocols in the massage and the comparison groups and specification of subject selection criteria. During Phase II, we will use the study components developed during Phase I to conduct a pilot trial evaluating the effectiveness and safety of massage for chronic neck pain. We will randomize 60 persons with chronic neck pain to therapeutic massage (n=30) or to a minimal self-care intervention (n=30). We will evaluate the effect of massage by comparing changes in symptoms, function, quality of life, and costs of back pain-related provider visits in these two groups midway through treatment, at the end of treatment, and at 6 months. Eligibility Ages Eligible for Study: 20 Years – 64 Years, Genders Eligible for Study: Both Criteria The inclusion and exclusion criteria will be developed through consultation with a medical expert on neck pain and several massage consultantsExpected Total Enrollment: 60 (Source/Sponsor:National Center for Complementary and Alternative Medicine (NCCAM) March 2004)