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Chiropractic Management of Chronic Lower Back Pain in Older Adults

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ClinicalTrials.gov Identifier: NCT00475787
Recruitment Status : Completed
First Posted : May 21, 2007
Results First Posted : December 30, 2014
Last Update Posted : December 30, 2014
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Low Back Pain Procedure: Spinal Manipulation Procedure: Detuned Ultrasound Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Chiropractic Management of Chronic Lower Back Pain in Older Adults
Study Start Date : April 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Spinal Manipulative therapy
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: 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.
 Procedure: Detuned Ultrasound
US machine is turned on and set at "0 w/cm2"
Other Name: Sham Procedure


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Medical Outcome Study Short Form 36(SF-36) Bodily Pain [ Time Frame: baseline and 5 Weeks ]
    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.

  2. Oswestry Disability Index (ODI) [ Time Frame: baseline and 5 weeks ]
    Validated measure of disability associated with lower back pain.

  3. Performance of the Timed up and go Test [ Time Frame: baseline and 5 weeks ]
    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.

  4. Medical Outcome Study Short Form Physical Functioning Subscale [ Time Frame: baseline and 5 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00475787


Locations
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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
US Department of Veterans Affairs
Investigators
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Principal Investigator: Paul Dougherty, DC VA Medical Center, Canandaigua
More Information
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Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00475787    
Other Study ID Numbers: CLIN-011-06F
First Posted: May 21, 2007    Key Record Dates
Results First Posted: December 30, 2014
Last Update Posted: December 30, 2014
Last Verified: December 2014
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
Older Adults
Patient Education
Randomized Controlled Trial
 Sham procedure
Spinal Manipulation
Veterans
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations