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Chiropractic and Exercise for Seniors With Neck Pain

N

Northwestern Health Sciences University

Status and phase

Completed
Phase 2

Conditions

Neck Pain

Treatments

Procedure: Chiropractic Manual treatment + home exercise ( procedure+behavior)
Procedure: Supervised rehabilitative exercise + home exercise
Behavioral: Home exercise

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT00269308
R18HP01425

Details and patient eligibility

About

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.

Full 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.

Enrollment

241 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

241 participants in 3 patient groups

1
Experimental group
Description:
Chiropractic Manual Treatment + Home Exercise
Treatment:
Procedure: Chiropractic Manual treatment + home exercise ( procedure+behavior)
2
Experimental group
Description:
Supervised Rehabilitative Exercise + Home Exercise
Treatment:
Procedure: Supervised rehabilitative exercise + home exercise
3
Active Comparator group
Description:
Home Exercise
Treatment:
Behavioral: Home exercise

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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