Elderly Back Pain: Comparing Chiropractic to Medical Care

Study Overview
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Brief Summary
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The purpose of this study is to compare the clinical effectiveness of two types of chiropractic spinal manipulation to conservative medical care for patients at least 55 years old with sub-acute or chronic low back pain (LBP).

Detailed Description
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Despite the high prevalence of LBP and the associated economic costs, disability, and lost productivity, and despite the development of several treatment guidelines, one of which recommends chiropractic spinal manipulation for some subgroups of patients with pack pain, the management of LBP remains controversial and highly variable across professions and geographic regions. Although one recent publication describes the design of chiropractic and exercise for seniors with low back or neck pain, no published studies to our knowledge, have assessed the effectiveness of chiropractic manipulation compared to medical care for older adults with sub-acute or chronic low back pain.

Official Title
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Elderly Back Pain: Comparing Chiropractic to Medical Care

Conditions
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Subacute Low Back Pain, Chronic Low Back Pain

Intervention / Treatment
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* Other: HVLA-SM
* Other: LVVA-SM
* Drug: Usual medical care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 55 or older Idiopathic low back pain (LBP) of at least four weeks duration Meet the diagnostic classification of 1, 2, or 3 according to the Quebec Task Force on Spinal Disorders Exclusion Criteria: Low back pain (LBP) not meeting Quebec Task Force Diagnostic Classifications 1, 2 or 3, especially LBP associated with: frank radiculopathy, altered lower extremity reflex, dermatomal sensory deficit, progressive unilateral muscle weakness or motor loss, symptoms of cauda equina compression, and CT or MRI evidence of anatomical pathology (e.g. abnormal disc, lateral or central stenosis. Co-morbid conditions or general poor health that could significantly complicate the prognosis of LBP, including pregnancy, bleeding disorders, extreme obesity, and clear evidence of narcotic or other drug abuse. Major clinical depression defined as scores greater that 29 on the Beck Depression Inventory - Second Edition Bone or joint pathology that contraindicate spinal manipulative therapy of joint pathology that contraindicate spinal manipulative therapy of the arthropathies and significant osteoporosis Pacemaker, because there are safety issues with equipment used to collect data in the biomechanical testing laboratory Current or pending litigation related to current episode of LBP. Receiving disability for any health-related condition Spinal Manipulative care for any reason within the past month Unwilling to postpone use of manual therapies for LBP except those provided in the study for the duration of the study period. Unable to read or verbally comprehend English.

Ages Eligible for Study
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Minimum Age: 55 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: HVLA-SM<br>High-velocity low amplitude spinal manipulation (HVLA-SM) | Other: HVLA-SM<br>* High-velocity low amplitude spinal manipulation (HVLA-SM)<br>|
| Experimental: LVVA-SM<br>Low-velocity variable amplitude spinal manipulation (LVVA-SM) | Other: LVVA-SM<br>* Low-velocity variable amplitude spinal manipulation (LVVA-SM)<br>|
| Active Comparator: Usual Medical Care<br>Usual medical care - (Celebrex, Aleve, Bextra, Naproxen) | Drug: Usual medical care<br>* Celebrex: po, 200mg, qd, six weeks; Aleve: po, 220mg, bid, six weeks; Bextra: po, 10mg, qd, six weeks; Naproxen: po, 500mg, bid, six weeks.<br>* Other names: (Celebrex, Aleve, Bextra, Naproxen);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland Morris Disability Questionnaire(RMDQ). |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fear Avoidance Beliefs Questionnaire, physical subscale |  | 6 weeks, 3 months, 6 months | 
| Visual Analogue Scale for Pain |  | 6 weeks | 
| Postural Sway |  | 6 weeks | 
| SF-36, v1, Physical Function subscale |  | 6 weeks | 
| Posteroanterior Spinal Stiffness |  | 6 weeks | 
| Sit-to-Stand Maneuver |  | 6 weeks | 
| Spinal Manipulation |  | 6 weeks |