Manipulation, Exercise, and Self-Care for Neck Pain

Northwestern Health Sciences University

Status and phase

Completed

Phase 2

Conditions

Neck Pain

Treatments

Procedure: Chiropractic + Supervised Rehabilitative Exercise

Procedure: Supervised Rehabilitative Exercise

Behavioral: Self-care education

Study type

Interventional

Funder types

Other

Other U.S. Federal agency

Identifiers

NCT00269360

R18HP10013

Details and patient eligibility

About

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.

Full 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:

rehabilitative exercise
chiropractic spinal manipulation combined with rehabilitative exercise
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.

Enrollment

270 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Chronic mechanical neck pain (defined as current episode > 12 weeks' duration).
Quebec Task Force classifications 1, 2, 3 and 4. This includes patients with neck pain, stiffness or tenderness, with or without musculoskeletal and neurological signs.

Exclusion criteria

Previous cervical spine surgery
Neck pain referred from local joint lesions of the lower extremities or from visceral diseases
Progressive neurological deficits due to nerve root or spinal cord compression
Existing cardiac disease requiring medical treatment
Blood clotting disorders
Diffuse idiopathic hyperostosis
Infectious and non-infectious inflammatory or destructive tissue changes of the cervical spine
Presence of significant infectious disease, or other severe disabling health problems
Substance abuse
Ongoing treatment for neck pain by other health care providers
Pregnant or nursing women
Average neck pain score of less than 30 percentage points
Pending or current litigation