Chiropractic Management of Chronic Lower Back Pain in Older Adults

Study Overview
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Brief Summary
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The purpose of this study is to determine the effectiveness of Chiropractic management for treatment of chronic lower back pain in older adults.

Detailed Description
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The identification of alternative safe and effective interventions for chronic lower back pain in the elderly is critical in view of its high prevalence, negative impact on quality of life and the treatment risks associated with chronic medication use. This is particularly germane to the veteran population, with a prevalence of lower back pain in excess of 40%. In 1998, published guidelines from the American Geriatric Society listed chiropractic management among the non-pharmacologic strategies for treating chronic pain symptoms in older adults. A recent study showed that a substantial number of older patients who received chiropractic care were less likely to be hospitalized, less likely to have used a nursing home, more likely to report a better health status, more likely to exercise vigorously and more likely to be mobile in the community. Patients undergoing chiropractic care have also reported greater satisfaction as compared to standard medical care. Despite the general clinical acceptance of chiropractic care and satisfaction with chiropractic services, evidence on the potential benefit and safety of chiropractic management of lower back pain in older adults is lacking. The purpose of this study is to evaluate the effectiveness of chiropractic management in older adults with chronic lower back pain, by comparing spinal manipulation to a sham intervention.

Official Title
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Chiropractic Management of Chronic Lower Back Pain in Older Adults

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Procedure: Spinal Manipulation
* Procedure: Detuned Ultrasound


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pain greater than three months in duration Localized pain to the lumbosacral and gluteal regions and no focal radicular symptoms Pain elicited upon deep palpation of the lumbar erector spinae musculature 4) Pain that can be either exacerbated or relieved by varying body position Exclusion Criteria: Patients will be excluded if they have a history of fragility fracture of radiographic evidence of lumbar compression fracture Patient will be excluded if they have undergone a course of previous chiropractic care Severely demented patients, as indicated by their previous medical history and Mini Mental State scores of 22 or less, will not be selected. The exclusion criteria are representative of the absolute contraindications for chiropractic management, specifically to mean high velocity, low amplitude spinal manipulation.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Manipulative therapy<br>Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization. | Procedure: Spinal Manipulation<br>* Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.<br>|
| Sham Comparator: Detuned Ultrasound<br>Detuned Ultrasound involves utilizing an ultrasound machine that is set to 0 w/cm2 and US gel is applied to the spine for 11 minutes. | Procedure: Detuned Ultrasound<br>* US machine is turned on and set at 0 w/cm2<br>* Other names: Sham Procedure;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS) | 100 mm line with 0 being no pain and 100 mm being the worst pain I can imagine. | Baseline, 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medical Outcome Study Short Form 36(SF-36) Bodily Pain | For the Bodily pain subscale, the higher the number the less self-reported pain. The computed SF-36 pain subscale scores range from 2 to 12. | baseline and 5 Weeks | 
| Oswestry Disability Index (ODI) | Validated measure of disability associated with lower back pain. | baseline and 5 weeks | 
| Performance of the Timed up and go Test | The Timed Up and Go Test assesses the amount of time it takes an individual to rise from a standard arm chair, walk a distance of 3 meters, and return to the initial position resting against the back of the chair, in this case the measurement was performed utilizing lasers to assess the time to the three meter mark and also the return to sitting in the chair. | baseline and 5 weeks | 
| Medical Outcome Study Short Form Physical Functioning Subscale | For the Physical Functioning subscale, the higher the number the less self-reported limitations in physical function. The computed SF-36 physical function subscale scores range from 2 to 12. | baseline and 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older Adults, Patient Education, Randomized Controlled Trial, Sham procedure, Spinal Manipulation, Veterans