Manipulation, Exercise, and Self-Care for Neck Pain

Neck Pain Clinical Trial

Official title:

Manipulation, Exercise, and Self-Care for Neck Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269360
• Other study ID #: R18HP10013
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2005
• Last updated: November 19, 2007
• Start date: March 2001
• Est. completion date: February 2005

Study information

• Verified date: November 2007
• Source: Northwestern Health Sciences University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Wolfe-Harris Center for Clinical Studies	Bloomington	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern Health Sciences University	Berman Center for Outcomes and Clinical Research, Health Resources and Services Administration (HRSA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient rated pain(0-10 scale,11 box)		short term = 12 weeks; long term = 52 weeks
Secondary	Neck Disability Index (NDI)at baseline, weeks 4,12,26,52		short term = 12 weeks; long term = 52 weeks
Secondary	General health status at baseline, weeks 4,12,26,52		short term = 12 weeks; long term = 52 weeks
Secondary	Improvement (Global Change)at baseline, weeks 4,12,26,52		short term = 12 weeks; long term = 52 weeks
Secondary	Disability Days at baseline, weeks 4,12,26,52		short term = 12 weeks; long term = 52 weeks
Secondary	Bothersomeness of Symptoms at baseline, weeks 4,12,26,52		short term = 12 weeks; long term = 52 weeks
Secondary	Frequency of Symptoms at baseline, weeks 4,12,26,52		short term = 12 weeks; long term = 52 weeks
Secondary	Patient Satisfaction at baseline, weeks 4,12,26,52		short term = 12 weeks; long term = 52 weeks
Secondary	Depression at baseline, weeks 4,12,26,52		short term = 12 weeks; long term = 52 weeks
Secondary	Medication use at baseline, weeks 4,12,26,52		short term = 12 weeks; long term = 52 weeks
Secondary	Fear-Avoidance Beliefs at baseline, weeks 4,12,26,52		short term = 12 weeks; long term = 52 weeks
Secondary	Cervical range of motion at baseline, weeks 4,12		short term = 12 weeks
Secondary	Cervical Strength and Endurance at baseline, weeks 4,12		short term = 12 weeks
Secondary	Health Care Costs and Utilization at weeks 4,12,26,52		short term = 12 weeks; long term = 52 weeks
Secondary	In-depth Interview at week 12		12 weeks

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