Chiropractic Management of Chronic Lower Back Pain in Older Adults

Chronic Low Back Pain Clinical Trial

Official title:

Chiropractic Management of Chronic Lower Back Pain in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475787
• Other study ID #: CLIN-011-06F
• Status: Completed
• Phase: N/A
• First received: May 17, 2007
• Last updated: December 16, 2014
• Start date: April 2008
• Est. completion date: April 2011

Study information

• Verified date: December 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Low Back Pain

Intervention

Procedure:
• Spinal Manipulation
Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
• Detuned Ultrasound
US machine is turned on and set at "0 w/cm2"

Locations

Country	Name	City	State
United States	VA Western New York Healthcare System at Buffalo	Buffalo	New York
United States	VA Medical Center, Canandaigua	Canandaigua	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms of Chronic Lower Back Pain as Measured With the Visual Analog Scale (VAS)	100 mm line with 0 being "no pain" and 100 mm being "the worst pain I can imagine".	Baseline, 5 weeks	No
Secondary	Medical Outcome Study Short Form 36(SF-36) Bodily Pain	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.	baseline and 5 Weeks	No
Secondary	Oswestry Disability Index (ODI)	Validated measure of disability associated with lower back pain.	baseline and 5 weeks	No
Secondary	Performance of the Timed up and go Test	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.	baseline and 5 weeks	No
Secondary	Medical Outcome Study Short Form Physical Functioning Subscale	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.	baseline and 5 weeks	No