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: December 16, 2014
Last verified: December 2014
  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
Procedure: Detuned Ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel 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:


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: Baseline, 5 weeks ] [ Designated as safety issue: No ]
    100 mm line with 0 being "no pain" and 100 mm being "the worst pain I can imagine".


Secondary Outcome Measures:
  • Medical Outcome Study Short Form 36(SF-36) Bodily Pain [ Time Frame: baseline and 5 Weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Validated measure of disability associated with lower back pain.

  • Performance of the Timed up and go Test [ Time Frame: baseline and 5 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


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: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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
Results First Received: October 21, 2014
Last Updated: December 16, 2014
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
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on August 30, 2015