| May 17, 2007 |
| August 18, 2009 |
| April 2008 |
| June 2010 (final data collection date for primary outcome measure) |
| Symptoms of chronic lower back pain as measured with the Visual Analog Scale (VAS) [ Time Frame: VAS performed at baseline, immediately post baseline and at three months post baseline ] [ Designated as safety issue: No ] |
- 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 ]
|
| Complete list of historical versions of study NCT00475787 on ClinicalTrials.gov Archive Site |
- Medical Outcome Study Short Form 36(SF-36) bodily pain and physical functioning subscales [ Time Frame: 4 weeks of treatment ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- Performance of the timed up and go test will improve to agreater extent with chiropractic management as compared to placebo that uses a sham chiropractic management [ Time Frame: 4 weeks of treatment ] [ Designated as safety issue: No ]
|
| 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 ] |
| |
| Chiropractic Management of Chronic Lower Back Pain in Older Adults |
| 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. |
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. Patient's 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. |
| |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Active Control, Factorial Assignment, Efficacy Study |
| Chronic Low Back Pain |
| Procedure: Spinal Manipulation |
- Experimental: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.
- Sham Comparator: Detuned Ultrasound
|
- Bressler HB, Keyes WJ, Rochon PA, Badley E. The prevalence of low back pain in the elderly. A systematic review of the literature. Spine. 1999 Sep 1;24(17):1813-9.
- Hawk C, Long CR, Boulanger KT, Morschhauser E, Fuhr AW. Chiropractic care for patients aged 55 years and older: report from a practice-based research program. J Am Geriatr Soc. 2000 May;48(5):534-45.
- Ernst E, Harkness E. Spinal manipulation: a systematic review of sham-controlled, double-blind, randomized clinical trials. J Pain Symptom Manage. 2001 Oct;22(4):879-89. Review.
- Hertzman-Miller RP, Morgenstern H, Hurwitz EL, Yu F, Adams AH, Harber P, Kominski GF. Comparing the satisfaction of low back pain patients randomized to receive medical or chiropractic care: results from the UCLA low-back pain study. Am J Public Health. 2002 Oct;92(10):1628-33.
- Assendelft WJ, Morton SC, Yu EI, Suttorp MJ, Shekelle PG. Spinal manipulative therapy for low back pain. Cochrane Database Syst Rev. 2004;(1):CD000447. Review.
- Muller R, Giles LG. Long-term follow-up of a randomized clinical trial assessing the efficacy of medication, acupuncture, and spinal manipulation for chronic mechanical spinal pain syndromes. J Manipulative Physiol Ther. 2005 Jan;28(1):3-11.
- Cherkin DC, Deyo RA, Battie M, Street J, Barlow W. A comparison of physical therapy, chiropractic manipulation, and provision of an educational booklet for the treatment of patients with low back pain. N Engl J Med. 1998 Oct 8;339(15):1021-9.
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| |
| Recruiting |
| 216 |
| September 2010 |
| June 2010 (final data collection date for primary outcome measure) |
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.
|
| Both |
| 65 Years and older |
| No |
|
|
| United States |
| |
| NCT00475787 |
| Dougherty, Paul - Principal Investigator, Department of Veterans Affairs |
| CLIN-011-06F |
| Department of Veterans Affairs |
|
| Principal Investigator: |
Paul Dougherty, DC |
VA Medical Center, Canandaigua |
|
|
| Department of Veterans Affairs |
| August 2009 |