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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 )

Tracking Information
First Submitted Date  ICMJE May 17, 2007
First Posted Date  ICMJE May 21, 2007
Results First Submitted Date  ICMJE October 21, 2014
Results First Posted Date  ICMJE December 30, 2014
Last Update Posted Date December 30, 2014
Study Start Date  ICMJE April 2008
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
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".
Original Primary Outcome Measures  ICMJE
 (submitted: May 17, 2007)
  • Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS)
  • Medical Outcome Study Short Form 36(SF-36) bodily pain and physical functioning subscales
  • 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 ]
Change History Complete list of historical versions of study NCT00475787 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2014)
  • 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.
  • Oswestry Disability Index (ODI) [ Time Frame: baseline and 5 weeks ]
    Validated measure of disability associated with lower back pain.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 17, 2007)
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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chiropractic Management of Chronic Lower Back Pain in Older Adults
Official Title  ICMJE Chiropractic Management of Chronic Lower Back Pain in Older Adults
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic Low Back Pain
Intervention  ICMJE
  • Procedure: Spinal Manipulation
    Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
  • Procedure: Detuned Ultrasound
    US machine is turned on and set at "0 w/cm2"
    Other Name: Sham Procedure
Study Arms  ICMJE
  • Experimental: Spinal Manipulative therapy
    Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
    Intervention: Procedure: Spinal Manipulation
  • 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.
    Intervention: Procedure: Detuned Ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 4, 2011)
136
Original Estimated Enrollment  ICMJE
 (submitted: May 17, 2007)
200
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00475787
Other Study ID Numbers  ICMJE CLIN-011-06F
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party VA Office of Research and Development ( US Department of Veterans Affairs )
Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Paul Dougherty, DC VA Medical Center, Canandaigua
PRS Account VA Office of Research and Development
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP