Clinical trial NCT00269308: Chiropractic and Exercise for Seniors With Neck Pain
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neck Pain
Keywords: Randomized
Clinical Trial
Neck Pain
Chiropractic
Manual Therapies
Exercise
Lead sponsor: Northwestern Health Sciences University
Sponsor class: OTHER
Collaborators: name: Health Resources and Services Administration (HRSA)
name: Berman Center for Outcomes and Clinical Research
First posted: 2005-12-23
Enrollment: 241
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Patient-rated pain (0-10 scale, 11 box)
timeFrame: short term = 12 weeks; long term = 52 weeks
Secondary outcomes:
measure: General Health
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: Disability
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: Improvement
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: Satisfaction
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: Medication use
timeFrame: short term = 12 weeks; long term = 52 weeks
measure: Biomechanical tests: Cervical spine motion, Strength and Endurance, Functional Ability, Observed Pain Behavior
timeFrame: short term = 12 weeks
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Wolfe-Harris Center for Clinical Studies, Northwestern Health Sciences University
state: Minnesota
Study officials:
affiliation: Northwestern Health Sciences University
name: Gert Bronfort, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leininger B, McDonough C, Evans R, Tosteson T, Tosteson AN, Bronfort G. Cost-effectiveness of spinal manipulative therapy, supervised exercise, and home exercise for older adults with chronic neck pain. Spine J. 2016 Nov;16(11):1292-1304. doi: 10.1016/j.spinee.2016.06.014. Epub 2016 Jun 23.
citation: Maiers M, Bronfort G, Evans R, Hartvigsen J, Svendsen K, Bracha Y, Schulz C, Schulz K, Grimm R. Spinal manipulative therapy and exercise for seniors with chronic neck pain. Spine J. 2014 Sep 1;14(9):1879-89. doi: 10.1016/j.spinee.2013.10.035. Epub 2013 Nov 10.
citation: 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. doi: 10.1186/1471-2474-8-94.