Dosing Study of Massage for Neck Pain
Condition: Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This study is designed to determine the most effective dose of massage for persons with
      chronic neck pain. This information is necessary before more definitive studies can be
      conducted.
    

Detailed description: 
      This study's long-term objective is to identify effective treatments for with neck pain. Many
      Americans have found conventional medical treatments ineffective for this common and costly
      problem and are increasingly trying complementary and alternative treatments, including
      therapeutic massage. Despite the growing popularity of massage, its effectiveness for
      treating neck pain remains unclear, largely because of the poor quality of research in this
      area. A major deficiency of previous studies has been their use of low "doses" of massage
      that massage therapists consider inadequate. Unfortunately, the numbers of minutes per
      massage session, sessions per weeks, or weeks of treatment necessary for massage to have
      beneficial or optimal effects are not known. This study is designed to address these gaps in
      our knowledge by determining, for persons with chronic neck pain: 1) the optimal combination
      of number of treatments per week and length of individual treatment session, and 2) the
      optimal number of weeks of treatment. In this project, 228 persons with chronic non-specific
      neck pain will be randomized to a wait list control group or 4 weeks of treatment with one of
      5 different dosing combinations (2 or 3 30-minute treatments per week or 1, 2, or 3 60-minute
      treatments per week). At the end of this 4 week primary treatment period, participants
      initially receiving each of the 5 dosing combinations will be randomized to a secondary
      treatment period of either no additional treatment or 6 weekly 60-minute massages. The
      primary outcomes, neck-related dysfunction and pain, will be assessed by blinded telephone
      interviewers 4, 10, and 26 weeks post-randomization. To better characterize the trajectory of
      the persistence of treatment effects, these interview data will be supplemented with outcomes
      data collected by mailed questionnaire at 8, 14, 18 and 39 weeks. Comparisons of outcomes for
      the 6 groups during the primary treatment period will identify the optimal weekly dose, while
      comparisons of outcomes during the secondary treatment period will determine if 10 weeks of
      treatment is superior to 4 weeks. The results of this study will: 1) guide the development of
      a massage treatment protocol to be used in a full-scale trial evaluating the effectiveness of
      therapeutic massage for chronic neck pain, 2) serve as a model for future dosing studies of
      massage and bodywork, and 3) help interpret the adequacy of the dosing of massage used in
      past studies of massage for neck pain
    

Intervention name(s): Massage
Intervention type(s): Other
Intervention description(s): Therapeutic Massage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Massage; Chronic Neck Pain; Dosing Study