Chiropractic and Exercise for Seniors With Neck Pain

Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00269308
• Other study ID #: R18HP01425
• Status: Completed
• Phase: Phase 2
• First received: December 21, 2005
• Last updated: August 22, 2011
• Start date: October 2003
• Est. completion date: April 2008

Study information

• Verified date: August 2011
• 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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)

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 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
• 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

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.

Locations

Country	Name	City	State
United States	Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University	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	No
Secondary	General Health		short term = 12 weeks; long term = 52 weeks	No
Secondary	Disability		short term = 12 weeks; long term = 52 weeks	No
Secondary	Improvement		short term = 12 weeks; long term = 52 weeks	No
Secondary	Satisfaction		short term = 12 weeks; long term = 52 weeks	No
Secondary	Medication use		short term = 12 weeks; long term = 52 weeks	No
Secondary	Biomechanical tests: Cervical spine motion, Strength and Endurance, Functional Ability, Observed Pain Behavior		short term = 12 weeks	No

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