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Chiropractic Management of Chronic Lower Back Pain in Older Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00475787
First received: May 17, 2007
Last updated: February 21, 2013
Last verified: February 2013
History of Changes
  Purpose

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


Condition Intervention
Chronic Low Back Pain
 Procedure: Spinal Manipulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chiropractic Management of Chronic Lower Back Pain in Older Adults

Resource links provided by NLM:

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Symptoms of chronic lower back pain as measured with the Visual Analog Scale (VAS) [ Time Frame: VAS performed at baseline, immediately post baseline and at three months post baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Medical Outcome Study Short Form 36(SF-36) bodily pain and physical functioning subscales [ Time Frame: 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Oswestry Disability Index (ODI) will improve to a greater extent with chiropractic management as compared to sham chiropractic management [ Time Frame: 4 weeks of treatment ] [ Designated as safety issue: No ]
  • Performance of the timed up and go test will improve to a greater extent with chiropractic management as compared to placebo that uses a sham chiropractic management [ Time Frame: 4 weeks of treatment ] [ Designated as safety issue: No ]

Enrollment: 136
Study Start Date: April 2008
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
 Procedure: Spinal Manipulation
Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
Sham Comparator: Arm 2
Detuned Ultrasound
 Procedure: Spinal Manipulation
Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00475787

Locations
United States, New York
VA Western New York Healthcare System at Buffalo
Buffalo, New York, United States, 14215
VA Medical Center, Canandaigua
Canandaigua, New York, United States, 14424
Sponsors and Collaborators
Department of Veterans Affairs
Investigators
Principal Investigator: Paul Dougherty, DC VA Medical Center, Canandaigua
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00475787     History of Changes
Other Study ID Numbers: CLIN-011-06F
Study First Received: May 17, 2007
Last Updated: February 21, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Older Adults
Patient Education
Randomized Controlled Trial
 Sham procedure
Spinal Manipulation
Veterans

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 21, 2013