Clinical trial NCT00269360: Manipulation, Exercise, and Self-Care for Neck Pain
Official title: Manipulation, Exercise, and Self-Care for Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neck Pain
Keywords: Chiropractic
Manual Therapies
Exercise
Randomized
Clinical Trial
Neck Pain
Lead sponsor: Northwestern Health Sciences University
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
name: Berman Center for Outcomes and Clinical Research
First posted: 2005-12-23
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient rated pain(0-10 scale,11 box)
timeFrame: short term = 12 weeks; long term = 52 weeks
Secondary outcomes:
measure: Neck Disability Index (NDI)at baseline, weeks 4,12,26,52
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: General health status at baseline, weeks 4,12,26,52
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: Improvement (Global Change)at baseline, weeks 4,12,26,52
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: Disability Days at baseline, weeks 4,12,26,52
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: Bothersomeness of Symptoms at baseline, weeks 4,12,26,52
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: Frequency of Symptoms at baseline, weeks 4,12,26,52
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: Patient Satisfaction at baseline, weeks 4,12,26,52
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: Depression at baseline, weeks 4,12,26,52
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: Medication use at baseline, weeks 4,12,26,52
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: Fear-Avoidance Beliefs at baseline, weeks 4,12,26,52
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: Cervical range of motion at baseline, weeks 4,12
timeFrame: short term = 12 weeks
measure: Cervical Strength and Endurance at baseline, weeks 4,12
timeFrame: short term = 12 weeks
measure: Health Care Costs and Utilization at weeks 4,12,26,52
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: In-depth Interview at week 12
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Wolfe-Harris Center for Clinical Studies
state: Minnesota
Study officials:
affiliation: Northwestern Health Sciences University
name: Gert Bronfort, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Evans R, Bronfort G, Schulz C, Maiers M, Bracha Y, Svendsen K, Grimm R, Garvey T, Transfeldt E. Supervised exercise with and without spinal manipulation performs similarly and better than home exercise for chronic neck pain: a randomized controlled trial. Spine (Phila Pa 1976). 2012 May 15;37(11):903-14. doi: 10.1097/BRS.0b013e31823b3bdf.