Chiropractic and Exercise for Seniors With Neck Pain - Full Text View

Sponsor:	Northwestern Health Sciences University
Collaborators:	Health Resources and Services Administration (HRSA) Berman Center for Outcomes and Clinical Research
Information provided by (Responsible Party):	Northwestern Health Sciences University
ClinicalTrials.gov Identifier:	NCT00269308

Purpose

The purpose of this randomized clinical trial is to assess the relative effectiveness of three conservative treatment approaches for seniors with chronic neck pain: 1) chiropractic manual treatment plus home exercise, 2) supervised exercise plus home exercise and 3) home exercise alone.

Condition	Intervention	Phase
Neck Pain	Procedure: Chiropractic Manual treatment + home exercise ( procedure+behavior) Procedure: Supervised rehabilitative exercise + home exercise Behavioral: Home exercise	Phase II

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:	Randomized Clinical Trial of Chiropractic Manual Therapy Plus Home Exercise, Supervised Exercise Plus Home Exercise and Home Exercise Alone For Individual 65 and Over With Chronic Mechanical Neck Pain

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Neck Injuries and Disorders Rehabilitation

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

General Health [ Time Frame: short term = 12 weeks; long term = 52 weeks ] [ Designated as safety issue: No ]
Disability [ Time Frame: short term = 12 weeks; long term = 52 weeks ] [ Designated as safety issue: No ]
Improvement [ Time Frame: short term = 12 weeks; long term = 52 weeks ] [ Designated as safety issue: No ]
Satisfaction [ Time Frame: short term = 12 weeks; long term = 52 weeks ] [ Designated as safety issue: No ]
Medication use [ Time Frame: short term = 12 weeks; long term = 52 weeks ] [ Designated as safety issue: No ]
Biomechanical tests: Cervical spine motion, Strength and Endurance, Functional Ability, Observed Pain Behavior [ Time Frame: short term = 12 weeks ] [ Designated as safety issue: No ]

Enrollment:	241
Study Start Date:	October 2003
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Chiropractic Manual Treatment + Home Exercise	Procedure: Chiropractic Manual treatment + home exercise ( procedure+behavior) The number of treatments will be determined by the individual chiropractor. Chiropractic manual treatment will be limited to gentle spinal manipulation and mobilization with light soft tissue massage as indicated to facilitate the manual therapy. Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active
Experimental: 2 Supervised Rehabilitative Exercise + Home Exercise	Procedure: Supervised rehabilitative exercise + home exercise The rehabilitative exercise program will consist of 20, 1 hour small-group sessions. It is a modification of exercise protocols used in previous studies by the investigators and others and incorporates recommendations of leading rehabilitative exercise specialists. The program will include exercises that reduce joint stiffness and relax elastic structures resulting in lower joint loads during movements. Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active
Active Comparator: 3 Home Exercise	Behavioral: Home exercise Patients will attend 4, 1-hour small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about neck pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.

Detailed Description:

Neck pain (NP) is a considerable health problem, affecting both young and elderly individuals. Of particular concern is the negative impact NP may have on the functional ability of the geriatric population, already challenged by decreased mobility and balance associated with ageing. Chiropractic manual treatment and rehabilitative exercise have demonstrated potential for the treatment of NP in younger individuals, but have yet to be rigorously tested in the elderly.

The broad, long-term objective of this research is to identify effective therapies for patients, 65 years and older, who suffer with chronic neck pain and to enhance their functional capacity.

Primary Aims

• To determine the relative clinical effectiveness of 1) chiropractic manual treatment and home exercise, 2) supervised rehabilitative exercise and home exercise, and 3) home exercise alone in both the short-term (after 12 weeks) and long-term (after 52 weeks), using patient-rated neck pain as the main outcome measure.

Secondary Aims

To estimate the short- and long-term relative effectiveness of the three interventions using:
- Patient-rated outcomes: neck related disability, general health status, patient satisfaction, improvement, and medication use measured by self-report questionnaires;
- Objective functional performance outcomes: neck motion, strength and endurance, and functional ability measured by examiners masked to treatment group assignment;
- Cost measures: direct and indirect costs, and cost utility of treatment measured by questionnaires, phone interviews, and medical records.
To describe patients' perceptions of treatment and the issues they consider when determining their satisfaction with care.

This project is a collective effort by a multidisciplinary team, with an established record of collaborative research in the area of neck and back pain. The results of this study will provide valuable information for elderly neck pain sufferers and the clinicians who treat them.

Eligibility

Ages Eligible for Study:	65 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Chronic neck pain (Defined as current episode more than 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.
65 years of age and older
Independent ambulation
Community dwelling (residency outside nursing home)
Score of 20 or more on Folstein Mini-Mental State Examination
Stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in previous month)

Exclusion Criteria:

Referred neck pain from local joint lesions of the upper extremities or from visceral diseases
Significant infectious disease
Ongoing treatment for neck pain by other health care providers
Mean neck pain score of less than 20 percentage points
Contraindications to exercise Determined by history or by referral to supplementary diagnostic tests (i.e., uncontrolled arrhythmias, third degree heart block, recent ECG changes, unstable angina, acute myocardial infarction, acute congestive heart failure, cardiomyopathy, valvular heart disease, poorly controlled blood pressure, uncontrolled metabolic disease)
Contraindications to spinal manipulation (i.e. Progressive neurological deficits, blood clotting disorders, severe osteoporosis, infectious and non-infectious inflammatory or destructive tissue changes of the spine)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00269308

Locations

United States, Minnesota
Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University
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):

Maiers MJ, Hartvigsen J, Schulz C, Schulz K, Evans RL, Bronfort G. Chiropractic and exercise for seniors with low back pain or neck pain: the design of two randomized clinical trials. BMC Musculoskelet Disord. 2007 Sep 18;8:94.

Responsible Party:	Northwestern Health Sciences University
ClinicalTrials.gov Identifier:	NCT00269308 History of Changes
Other Study ID Numbers:	R18HP01425
Study First Received:	December 21, 2005
Last Updated:	August 22, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern Health Sciences University:

Randomized
Clinical Trial
Neck Pain

Chiropractic
Manual Therapies
Exercise

Additional relevant MeSH terms:

Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 12, 2012