Manipulation, Exercise, and Self-Care for Neck Pain

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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Procedure: Chiropractic + Supervised Rehabilitative Exercise; Procedure: Supervised Rehabilitative Exercise; Behavioral: 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.

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Bloomington, Minnesota, United States, 55431
      • Wolfe-Harris Center for Clinical Studies

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Procedure: Chiropractic + Supervised Rehabilitative Exercise; 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.
Experimental: 2	Procedure: Supervised Rehabilitative Exercise; 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.
Active Comparator: 3	Behavioral: Self-care education; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Patient rated pain(0-10 scale,11 box)	short term = 12 weeks; long term = 52 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Neck Disability Index (NDI)at baseline, weeks 4,12,26,52	short term = 12 weeks; long term = 52 weeks
General health status at baseline, weeks 4,12,26,52	short term = 12 weeks; long term = 52 weeks
Improvement (Global Change)at baseline, weeks 4,12,26,52	short term = 12 weeks; long term = 52 weeks
Disability Days at baseline, weeks 4,12,26,52	short term = 12 weeks; long term = 52 weeks
Bothersomeness of Symptoms at baseline, weeks 4,12,26,52	short term = 12 weeks; long term = 52 weeks
Frequency of Symptoms at baseline, weeks 4,12,26,52	short term = 12 weeks; long term = 52 weeks
Patient Satisfaction at baseline, weeks 4,12,26,52	short term = 12 weeks; long term = 52 weeks
Depression at baseline, weeks 4,12,26,52	short term = 12 weeks; long term = 52 weeks
Medication use at baseline, weeks 4,12,26,52	short term = 12 weeks; long term = 52 weeks
Fear-Avoidance Beliefs at baseline, weeks 4,12,26,52	short term = 12 weeks; long term = 52 weeks
Cervical range of motion at baseline, weeks 4,12	short term = 12 weeks
Cervical Strength and Endurance at baseline, weeks 4,12	short term = 12 weeks
Health Care Costs and Utilization at weeks 4,12,26,52	short term = 12 weeks; long term = 52 weeks
In-depth Interview at week 12	12 weeks

Collaborators and Investigators

• Sponsor: Northwestern Health Sciences University
• Collaborators: Health Resources and Services Administration (HRSA); Berman Center for Outcomes and Clinical Research

Publications and helpful links

General Publications

• 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.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: March 1, 2001
• Study Completion (Actual): February 1, 2005

Study Registration Dates

• First Submitted: December 21, 2005
• First Submitted That Met QC Criteria: December 22, 2005
• First Posted (Estimate): December 23, 2005

Study Record Updates

• Last Update Posted (Estimate): November 20, 2007
• Last Update Submitted That Met QC Criteria: November 19, 2007
• Last Verified: November 1, 2007

More Information

Terms related to this study

• Keywords: Exercise; Randomized; Neck Pain; Clinical Trial; Chiropractic; Manual Therapies
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: R18HP10013