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Chiropractic Management of Chronic Lower Back Pain in Older Adults

NCT ID: NCT00475787

Last Updated: 2014-12-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2011-04-30

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.

Conditions

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Chronic Low Back Pain

Keywords

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Older Adults Patient Education Randomized Controlled Trial Sham procedure Spinal Manipulation Veterans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Spinal Manipulative therapy

Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.

Group Type EXPERIMENTAL

Spinal Manipulation

Intervention Type PROCEDURE

Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.

Detuned Ultrasound

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.

Group Type SHAM_COMPARATOR

Detuned Ultrasound

Intervention Type PROCEDURE

US machine is turned on and set at "0 w/cm2"

Interventions

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Spinal Manipulation

Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.

Intervention Type PROCEDURE

Detuned Ultrasound

US machine is turned on and set at "0 w/cm2"

Intervention Type PROCEDURE

Other Intervention Names

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Sham Procedure

Eligibility Criteria

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Inclusion Criteria

1. Pain greater than three months in duration
2. Localized pain to the lumbosacral and gluteal regions and no focal radicular symptoms
3. 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

1. Patients will be excluded if they have a history of fragility fracture of radiographic evidence of lumbar compression fracture
2. Patient will be excluded if they have undergone a course of previous chiropractic care
3. Severely demented patients, as indicated by their previous medical history and Mini Mental State scores of 22 or less, will not be selected.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Dougherty, DC

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, Canandaigua

Locations

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VA Western New York Healthcare System at Buffalo

Buffalo, New York, United States

Site Status

VA Medical Center, Canandaigua

Canandaigua, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CLIN-011-06F

Identifier Type: -

Identifier Source: org_study_id