Text Size

Manipulation, Exercise, and Self-Care for Neck Pain

This study has been completed.
Sponsor:
Collaborators:
Health Resources and Services Administration (HRSA)
Berman Center for Outcomes and Clinical Research
Information provided by:
Northwestern Health Sciences University
ClinicalTrials.gov Identifier:
NCT00269360
First received: December 21, 2005
Last updated: November 19, 2007
Last verified: November 2007
History of Changes
  Purpose

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.


Condition Intervention Phase
Neck Pain
 Procedure: Chiropractic + Supervised Rehabilitative Exercise
Procedure: Supervised Rehabilitative Exercise
Behavioral: Self-care education
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Manipulation, Exercise, and Self-Care for Neck Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Northwestern Health Sciences University:

Primary Outcome Measures:
  • Patient rated pain(0-10 scale,11 box) [ Time Frame: short term = 12 weeks; long term = 52 weeks ]

Secondary Outcome Measures:
  • 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 [ 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 ]

Enrollment: 270
Study Start Date: March 2001
Study Completion Date: February 2005
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00269360

Locations
United States, Minnesota
Wolfe-Harris Center for Clinical Studies
Bloomington, Minnesota, United States, 55431
Sponsors and Collaborators
Northwestern Health Sciences University
Health Resources and Services Administration (HRSA)
Berman Center for Outcomes and Clinical Research
Investigators
Principal Investigator: Gert Bronfort, DC, PhD Northwestern Health Sciences University
  More Information

No publications provided by Northwestern Health Sciences University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00269360     History of Changes
Other Study ID Numbers: R18HP10013
Study First Received: December 21, 2005
Last Updated: November 19, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern Health Sciences University:
Chiropractic
Manual Therapies
Exercise
 Randomized
Clinical Trial
Neck Pain

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013