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Manipulation, Exercise, and Self-Care for Neck Pain

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ClinicalTrials.gov Identifier: NCT00269360
Recruitment Status : Completed
First Posted : December 23, 2005
Last Update Posted : November 20, 2007
Sponsor:
Collaborators:
Health Resources and Services Administration (HRSA)
Berman Center for Outcomes and Clinical Research
Information provided by:
Northwestern Health Sciences University

Tracking Information
First Submitted Date  ICMJE December 21, 2005
First Posted Date  ICMJE December 23, 2005
Last Update Posted Date November 20, 2007
Study Start Date  ICMJE March 2001
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2007)
Patient rated pain(0-10 scale,11 box) [ Time Frame: short term = 12 weeks; long term = 52 weeks ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 22, 2005)
Patient rated pain(0-10 scale,11 box)
Change History Complete list of historical versions of study NCT00269360 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2007)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2005)
  • 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
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Manipulation, Exercise, and Self-Care for Neck Pain
Official Title  ICMJE Manipulation, Exercise, and Self-Care for Neck Pain
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.

Study Type  ICMJE Interventional
Study Phase Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Neck Pain
Intervention  ICMJE
  • 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.

  • 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.
  • 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.
Study Arms
  • Experimental: 1
    Intervention: Procedure: Chiropractic + Supervised Rehabilitative Exercise
  • Experimental: 2
    Intervention: Procedure: Supervised Rehabilitative Exercise
  • Active Comparator: 3
    Intervention: Behavioral: Self-care education
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 22, 2005)
270
Original Enrollment  ICMJE Same as current
Actual Study Completion Date February 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00269360
Other Study ID Numbers  ICMJE R18HP10013
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Northwestern Health Sciences University
Collaborators  ICMJE
  • Health Resources and Services Administration (HRSA)
  • Berman Center for Outcomes and Clinical Research
Investigators  ICMJE
Principal Investigator: Gert Bronfort, DC, PhD Northwestern Health Sciences University
PRS Account Northwestern Health Sciences University
Verification Date November 2007

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