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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
270
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.
Wolfe-Harris Center for Clinical Studies
Bloomington, Minnesota, United States
Patient rated pain(0-10 scale,11 box)
Time frame: short term = 12 weeks; long term = 52 weeks
Neck Disability Index (NDI)at baseline, weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
General health status at baseline, weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
Improvement (Global Change)at baseline, weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
Disability Days at baseline, weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
Bothersomeness of Symptoms at baseline, weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
Frequency of Symptoms at baseline, weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
Patient Satisfaction at baseline, weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
Depression at baseline, weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
Medication use at baseline, weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
Fear-Avoidance Beliefs at baseline, weeks 4,12,26,52
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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.
Time frame: short term = 12 weeks; long term = 52 weeks
Cervical range of motion at baseline, weeks 4,12
Time frame: short term = 12 weeks
Cervical Strength and Endurance at baseline, weeks 4,12
Time frame: short term = 12 weeks
Health Care Costs and Utilization at weeks 4,12,26,52
Time frame: short term = 12 weeks; long term = 52 weeks
In-depth Interview at week 12
Time frame: 12 weeks