Chiropractic and Exercise for Seniors With Neck Pain

Phase 2

Completed

• Conditions: Neck Pain
• Interventions: Procedure: Chiropractic Manual treatment + home exercise ( procedure+behavior); Procedure: Supervised rehabilitative exercise + home exercise; Behavioral: Home exercise

• Registration Number: NCT00269308
• Lead Sponsor: Northwestern Health Sciences University

Brief 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.

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.

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-12-21
• Study First Submitted QC: 2005-12-22
• Study First Posted: 2005-12-23
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Status Verified: 2011-08
• Last Update Submitted: 2011-08-22
• Last Update Posted: 2011-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Chiropractic Manual treatment + home exercise ( procedure+behavior)	Chiropractic Manual Treatment + Home Exercise
2	Supervised rehabilitative exercise + home exercise	Supervised Rehabilitative Exercise + Home Exercise
3	Home exercise	Home Exercise

Primary Outcome Measures

Name	Time	Method
Patient-rated pain (0-10 scale, 11 box)	short term = 12 weeks; long term = 52 weeks

Secondary Outcome Measures

Name	Time	Method
General Health	short term = 12 weeks; long term = 52 weeks
Disability	short term = 12 weeks; long term = 52 weeks
Improvement	short term = 12 weeks; long term = 52 weeks
Satisfaction	short term = 12 weeks; long term = 52 weeks
Medication use	short term = 12 weeks; long term = 52 weeks
Biomechanical tests: Cervical spine motion, Strength and Endurance, Functional Ability, Observed Pain Behavior	short term = 12 weeks

Trial Locations

Locations (1)

Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University; 🇺🇸 Bloomington, Minnesota, United States