search
Back to results

Manipulation, Exercise, and Self-Care for Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Chiropractic + Supervised Rehabilitative Exercise
Supervised Rehabilitative Exercise
Self-care education
Sponsored by
Northwestern Health Sciences University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Chiropractic, Manual Therapies, Exercise, Randomized, Clinical Trial, Neck Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Wolfe-Harris Center for Clinical Studies

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

1

2

3

Arm Description

Outcomes

Primary Outcome Measures

Patient rated pain(0-10 scale,11 box)

Secondary Outcome Measures

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

Full Information

First Posted
December 21, 2005
Last Updated
November 19, 2007
Sponsor
Northwestern Health Sciences University
Collaborators
Health Resources and Services Administration (HRSA), Berman Center for Outcomes and Clinical Research
search

1. Study Identification

Unique Protocol Identification Number
NCT00269360
Brief Title
Manipulation, Exercise, and Self-Care for Neck Pain
Official Title
Manipulation, Exercise, and Self-Care for Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
November 2007
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Northwestern Health Sciences University
Collaborators
Health Resources and Services Administration (HRSA), Berman Center for Outcomes and Clinical Research

4. Oversight

5. Study Description

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: rehabilitative exercise chiropractic spinal manipulation combined with rehabilitative exercise 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Chiropractic, Manual Therapies, Exercise, Randomized, Clinical Trial, Neck Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
270 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Chiropractic + Supervised Rehabilitative Exercise
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Supervised Rehabilitative Exercise
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-care education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient rated pain(0-10 scale,11 box)
Time Frame
short term = 12 weeks; long term = 52 weeks
Secondary Outcome Measure Information:
Title
Neck Disability Index (NDI)at baseline, weeks 4,12,26,52
Time Frame
short term = 12 weeks; long term = 52 weeks
Title
General health status at baseline, weeks 4,12,26,52
Time Frame
short term = 12 weeks; long term = 52 weeks
Title
Improvement (Global Change)at baseline, weeks 4,12,26,52
Time Frame
short term = 12 weeks; long term = 52 weeks
Title
Disability Days at baseline, weeks 4,12,26,52
Time Frame
short term = 12 weeks; long term = 52 weeks
Title
Bothersomeness of Symptoms at baseline, weeks 4,12,26,52
Time Frame
short term = 12 weeks; long term = 52 weeks
Title
Frequency of Symptoms at baseline, weeks 4,12,26,52
Time Frame
short term = 12 weeks; long term = 52 weeks
Title
Patient Satisfaction at baseline, weeks 4,12,26,52
Time Frame
short term = 12 weeks; long term = 52 weeks
Title
Depression at baseline, weeks 4,12,26,52
Time Frame
short term = 12 weeks; long term = 52 weeks
Title
Medication use at baseline, weeks 4,12,26,52
Time Frame
short term = 12 weeks; long term = 52 weeks
Title
Fear-Avoidance Beliefs at baseline, weeks 4,12,26,52
Time Frame
short term = 12 weeks; long term = 52 weeks
Title
Cervical range of motion at baseline, weeks 4,12
Time Frame
short term = 12 weeks
Title
Cervical Strength and Endurance at baseline, weeks 4,12
Time Frame
short term = 12 weeks
Title
Health Care Costs and Utilization at weeks 4,12,26,52
Time Frame
short term = 12 weeks; long term = 52 weeks
Title
In-depth Interview at week 12
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gert Bronfort, DC, PhD
Organizational Affiliation
Northwestern Health Sciences University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wolfe-Harris Center for Clinical Studies
City
Bloomington
State/Province
Minnesota
ZIP/Postal Code
55431
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22024905
Citation
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.
Results Reference
derived
Links:
URL
http://www.nwhealth.edu/research/WHCCS/
Description
Related Info

Learn more about this trial

Manipulation, Exercise, and Self-Care for Neck Pain

We'll reach out to this number within 24 hrs