Chiropractic and Exercise for Seniors With Low Back Pain

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

Detailed Description
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Low back pain (LBP) is a significant health problem for both young and geriatric individuals. Of particular concern is that conditions associated with LBP, such as impaired strength and flexibility, can have very serious consequences for an older individual's independence and overall health. The broad, long-term objective of this research is to identify effective therapies for low back pain (LBP) and to discover the best methods for enhancing health and functional capacity in the elderly population. This study is a multi-methods clinical trial consisting of a randomized clinical trial (RCT), a cost-effectiveness study alongside the RCT, and a qualitative study nested in the RCT. This trial builds upon a previous study of chiropractic and exercise funded by HRSA, and focuses on elderly patients with sub-acute and chronic low back pain. PRIMARY AIMS To determine the relative clinical effectiveness the following treatments for LBP patients 65 years and older in both the short-term (after 12 weeks) and long-term (after 52 weeks), using low back pain as the main outcome measure chiropractic manual treatment plus home exercise supervised rehabilitative exercise plus home exercise home exercise SECONDARY AIMS To estimate the short- and long-term relative effectiveness of the three interventions using: Patient-rated outcomes: low back disability, general health status, patient satisfaction, improvement, and medication use measured by self-report questionnaires Objective functional performance outcomes: spinal motion, trunk strength and endurance, and functional ability measured by examiners masked to treatment group assignment Cost measures: direct and indirect costs of treatment measured by questionnaires, phone interviews, and medical records. To describe elderly LBP patients' perceptions of treatment and the issues they consider when determining their satisfaction with care using qualitative methods nested within the RCT.

Official Title
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Randomized Clinical Trial of Chiropractic Manual Therapy Plus Home Exercise, Supervised Exercise Plus Home Exercise and Home Exercise Alone For Individuals 65 and Over With Chronic Mechanical Low Back Pain

Conditions
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Low Back Pain

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sub-Acute and chronic low back pain (Defined as current episode more than 6 weeks duration.) Quebec Task Force classifications 1, 2, 3 and 4. (This includes patients with back pain, stiffness or tenderness, with or without musculoskeletal signs and neurological signs.{1570}) 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{13246} Stable prescription medication plan (no changes in prescription medications that affect musculoskeletal pain in previous month) Exclusion Criteria: Referred low back pain from local joint lesions of the lower extremities or from visceral diseases Significant infectious disease Determined by history or by referral to supplementary diagnostic tests Ongoing treatment for low back pain by other health care providers Mean baseline low back pain score of 20 percentage points or less 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; infectious and non-infectious inflammatory or destructive tissue changes of the spine; severe osteoporosis)

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Procedure: Chiropractic Manual treatment + home exercise (procedure+behavior)<br>* The number of treatments will be determined by the individual chiropractor. Chiropractic manual treatment will be limited to gentle spinal manipulation, mobilization and flexion-distraction therapy with light soft tissue massage as indicated to facilitate the manual therapy. Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.<br>|
| Experimental: 2<br> | Procedure: Supervised rehabilitative exercise+home exercise<br>* The rehabilitative exercise program will consist of 20, 1-hour sessions. It is a modification of exercise protocols used in previous studies by the investigators and incorporates recommendations of leading rehabilitative exercise specialists. Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.<br>|
| Active Comparator: 3<br> | Behavioral: Home exercise<br>* Patients will attend 4, 45-minute small-group sessions at weeks 1, 2, 4 and 8. At the first two sessions they will be given information about low back pain and shown exercises to perform at home. Emphasis will be placed on the importance of staying active.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-rated pain (0-11 box scale) |  | short term = 12 weeks; long term = 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 test: Lumbar spinal motion Trunk strength & endurance Functional Ability Observed Pain Behavior |  | short term = 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized, Clinical Trial, Low Back Pain, Chiropractic, Manual Therapies, Exercise