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Completed

NCT Number: NCT00475787

Chiropractic Management of Chronic Lower Back Pain in Older Adults

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

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Western New York Healthcare System at Buffalo, Buffalo, New York, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pain greater than three months in duration
  • Localized pain to the lumbosacral and gluteal regions and no focal radicular symptoms
  • 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

  • Patients will be excluded if they have a history of fragility fracture of radiographic evidence of lumbar compression fracture
  • Patient will be excluded if they have undergone a course of previous chiropractic care
  • 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.

Treatment and study plan

Spinal manipulation

Procedure

Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.

Detuned Ultrasound

Procedure

US machine is turned on and set at "0 w/cm2"

Other names: Sham Procedure

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
May 21, 2007
Registry last updated
Dec 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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