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Clinical Trials/NCT00475787
NCT00475787CompletedNot Applicable

Chiropractic Management of Chronic Lower Back Pain in Older Adults

US Department of Veterans Affairs4 sites in 1 country136 target enrollmentStarted: April 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
136
Locations
4
Primary Endpoint
Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS)

Study Overview

Brief Summary

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

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS)

Time Frame: Baseline, 5 weeks

100 mm line with 0 being "no pain" and 100 mm being "the worst pain I can imagine".

Secondary Outcomes

  • Performance of the Timed up and go Test(baseline and 5 weeks)
  • Medical Outcome Study Short Form Physical Functioning Subscale(baseline and 5 weeks)
  • Medical Outcome Study Short Form 36(SF-36) Bodily Pain(baseline and 5 Weeks)
  • Oswestry Disability Index (ODI)(baseline and 5 weeks)

Investigators

Sponsor Class
Fed
Responsible Party
Sponsor

Study Sites (4)

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