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Manipulation, Exercise, and Self-Care for Neck Pain
This study has been completed.
Study NCT00269360   Information provided by Northwestern Health Sciences University
First Received: December 21, 2005   Last Updated: November 19, 2007   History of Changes

December 21, 2005
November 19, 2007
March 2001
 
Patient rated pain(0-10 scale,11 box) [ Time Frame: short term = 12 weeks; long term = 52 weeks ]
Patient rated pain(0-10 scale,11 box)
Complete list of historical versions of study NCT00269360 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Neck Disability Index (NDI)at basline, weeks 4,12,26,52
  • General health status at basline, weeks 4,12,26,52
  • Improvement (Global Change)at basline, weeks 4,12,26,52
  • Disability Days at basline, weeks 4,12,26,52
  • Bothersomeness of Symptoms at basline, weeks 4,12,26,52
  • Frequency of Symptoms at basline, weeks 4,12,26,52
  • Patient Satisfaction at basline, weeks 4,12,26,52
  • Depression at basline, weeks 4,12,26,52
  • Medication use at basline, weeks 4,12,26,52
  • Fear-Avoidance Beliefs at basline, weeks 4,12,26,52
  • Cervical range of motion at basline, weeks 4,12
  • Cervical Strength and Endurance at basline, weeks 4,12
  • Health Care Costs and Utilization at weeks 4,12,26,52
  • In-depth Interview at week 12
 
Manipulation, Exercise, and Self-Care for Neck Pain
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.

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.

Phase II
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Neck Pain
  • Procedure: Chiropractic + Supervised Rehabilitative Exercise
  • Procedure: Supervised Rehabilitative Exercise
  • Behavioral: Self-care education
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
270
February 2005
 

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00269360
 
R18HP10013
Northwestern Health Sciences University
  • Health Resources and Services Administration (HRSA)
  • Berman Center for Outcomes and Clinical Research
Principal Investigator: Gert Bronfort, DC, PhD Northwestern Health Sciences University
Northwestern Health Sciences University
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP