Clinical trial NCT00475787: Chiropractic Management of Chronic Lower Back Pain in Older Adults
Official title: Chiropractic Management of Chronic Lower Back Pain in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: Older Adults
Patient Education
Randomized Controlled Trial
Sham procedure
Spinal Manipulation
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2007-05-21
Enrollment: 136
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

   * The exclusion criteria are representative of the absolute contraindications for chiropractic management, specifically to mean high velocity, low amplitude spinal manipulation.

Primary outcomes:
measure: Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS)
timeFrame: Baseline, 5 weeks
Secondary outcomes:
measure: Medical Outcome Study Short Form 36(SF-36) Bodily Pain
timeFrame: baseline and 5 Weeks
measure: Oswestry Disability Index (ODI)
timeFrame: baseline and 5 weeks
measure: Performance of the Timed up and go Test
timeFrame: baseline and 5 weeks
measure: Medical Outcome Study Short Form Physical Functioning Subscale
timeFrame: baseline and 5 weeks
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: VA Western New York Healthcare System at Buffalo
state: New York
city: Canandaigua
country: United States
facility: VA Medical Center, Canandaigua
state: New York
Study officials:
affiliation: VA Medical Center, Canandaigua
name: Paul Dougherty, DC
role: PRINCIPAL_INVESTIGATOR
References: