Manipulation, Exercise, and Self-Care for Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare three treatments for neck pain: 1) rehabilitative
      exercise, 2) chiropractic spinal manipulation combined with rehabilitative exercise, and 3)
      self-care education.
    

Detailed description: 
      Neck pain is very common, afflicting 10% of the population at any given time. Despite its
      significant socioeconomic impact, neck pain has been poorly investigated. The broad, long
      term objective of this interdisciplinary research is to identify effective therapies for neck
      pain and to increase our knowledge of this problematic condition. This multidisciplinary,
      randomized clinical trial is based on the investigators' previous neck pain research and will
      assess three treatment approaches for chronic neck pain:

        1. rehabilitative exercise

        2. chiropractic spinal manipulation combined with rehabilitative exercise

        3. self-care education (a minimal intervention control)

      The primary aim of this study is to examine the relative efficacy of the three interventions
      in terms of patient-rated outcomes in the short term (after 12 weeks) and long term (after 52
      weeks) for chronic neck pain. Secondary aims are to assess the relative cost-effectiveness
      and cost utility of the three treatments, evaluate changes in objective cervical spine
      function, assess if cervical function is associated with changes in patient-rated outcomes,
      identify predictors of outcome and finally, to describe patients' interpretations of outcome
      measures used in clinical trials.

      Using previously demonstrated recruitment methods, 270 participants with chronic neck pain
      will be recruited. Self-reported outcome measures will be collected at baseline and 4, 12, 26
      and 52 weeks; objective outcome measures will be assessed by blinded examiners at baseline
      and 12 weeks.

      Chiropractic investigators from Northwestern Health Sciences University are collaborating
      with medical clinicians from the University of Minnesota, the Minneapolis Medical Research
      Foundation, and the Pain Assessment and Rehabilitation Center. This established team of
      investigators will work together in all phases of this innovative study, leading to
      dissemination and publication of study results and hypothesis generation for future research.
      This trial will yield important information allowing health care practitioners, policy makers
      and patients to make better-informed decisions regarding treatment choices for chronic neck
      pain. Importantly, it will serve to increase the extremely limited research that currently
      exists for this significant health-care condition.
    

Intervention name(s): Chiropractic + Supervised Rehabilitative Exercise; Supervised Rehabilitative Exercise; Self-care education
Intervention type(s): Procedure; Procedure; Behavioral
Intervention description(s): Chiropractic care will include manual spinal manipulation, with light soft tissue massage as indicated to facilitate the spinal manipulative therapy. The spinal levels treated will be determined by the individual chiropractors by static and/or motion palpation.
Patients will attend 20, 1 hour sessions of rehabilitative exercises for the neck and upper body. Each session will begin with a 10-minute aerobic warm-up of the upper body and five minutes of light stretching to prepare for the strengthening exercises.; Patients will attend 20, 1 hour sessions of rehabilitative exercises for the neck and upper body. Each session will begin with a 10-minute aerobic warm-up of the upper body and five minutes of light stretching to prepare for the strengthening exercises.; Self-care education will be provided by the therapist trained in the study protocol. Two, one-hour sessions will be given regarding self-care measures and ergonomics relative to work and activities of daily living. These will include postural instructions and practical demonstrations of proper body mechanics performed with patient participation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chiropractic; Manual Therapies; Exercise; Randomized; Clinical Trial; Neck Pain