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Outcome Assessment of Clinical Practice Guidelines in the Medical and Chiropractic Management of Patients with Acute Mechanical Lower Back Pain: A Randomized Control Trial
RS2003/04-007
Final Report Date: November 2007
| Principal Investigator: | Paul Bishop (Combined Neurosurgical and Orthopaedic Spine Program) |
| Co-investigators: | Charles Fisher, Marcel Dvorak (Combined Neurosurgical and Orthopaedic Spine Program); Jeff Quon (University of British Columbia) |
For more information about this project, please contact Dr. Paul Bishop.
Issue
Clinical practice guidelines have been developed for the treatment of patients with acute mechanical lower back pain, based on independent reviews of the international scientific literature. However, most patients with acute lower back pain do not receive guidelines-based treatment. A randomized clinical trial was conducted in the Non-operative Orthopaedic Spine Program at Vancouver General Hospital to explore whether patients have better outcomes when they receive guidelines-based treatment that includes a component of spinal manipulative therapy administered by chiropractors, compared with family physician-directed usual care.
Key findings
- The study was the first reported randomized clinical trial to compare full clinical practice guidelines-based treatment with family physician-directed usual care for acute lower back pain patients.
- Patients receiving guidelines-based care that included a component of spinal manipulative therapy administered by chiropractors had significantly better outcomes than those receiving usual care, including:
- Greater improvement in physical functioning (at 8 weeks and 24 weeks)
- Greater improvement in quality of life measures, including bodily pain and physical functioning (at 16 weeks)
- Information provided by patients indicated that the usual care group did not receive treatment that was in accordance with clinical guidelines.
Objectives
- To compare treatment outcomes for patients in two groups: those receiving guidelines-based therapies including a component of spinal manipulative therapy administered by chiropractors, and those receiving usual care from a family physician
- To advance the application of research evidence to improve the treatment of acute lower back pain
Method
Patients with acute lower back pain referred for assessment to the Combined Neurosurgical and Orthopaedic Spine Program (CNOSP) at Vancouver General Hospital, University of British Columbia, were invited to participate in the study if they met the eligibility criteria. A total of 88 patients were recruited.
All patients received an initial assessment in the CNOSP Outpatient clinic. Participating patients were randomly assigned into one of two groups: a usual care group or a guidelines-based care group.
Patients randomized to the usual care group were given their diagnosis of acute mechanical lower back pain and referred back to their family physician. A letter was sent to their physician explaining the study and advising them to treat the patient at their discretion. The usual care patients were seen at the spine clinic again at 8 and 16 weeks after their treatment began. They also provided information about the type of treatment they received from their family physician.
Patients in the guidelines-based care group received treatment in accordance with guidelines including:
- Reassurance that their symptoms were likely to resolve with time
- Advice to avoid treatments that contradict guidelines, such as the use of bed rest, heat, or the use of back supports, corsets, or braces
- Advice to walk twice per day for the length of time they could tolerate, and adding two minutes per week to each walk
- To use acetaminophen as a first line medication rather than an NSAID or muscle relaxant (unless inappropriate for medical reasons such as an allergy or compromised liver function)
- A maximum four-week course of spinal manipulative therapy administered by a chiropractor exclusively to the lumbar spine, two to three times a week (the chiropractors involved in this research modified their usual patterns of practice to match the recommended guidelines when treating patients in the study)
Patients in both groups completed outcome questionnaires at the beginning of the study, and again at 8, 16, and 24 weeks after treatment started. This provided data on functional capacity, physical functioning, and bodily pain.
Roland Disability Questionnaire and SF-36 scores were calculated for each group at 8, 16, and 24 weeks after treatment, and scores for the two groups were compared.
Results
- Patients with acute lower back pain receiving guidelines-based treatment that included a component of spinal manipulative therapy administered by chiropractors had significantly better outcomes than patients receiving usual care from a family physician.
- Patients receiving guidelines-based care had significantly greater improvement in physical functioning at 8 weeks and 24 weeks after treatment than those receiving usual care, and greater improvement in quality of life measures (bodily pain and physical functioning) at 16 weeks.
- There was not enough information to allow a comparison of return-to-work times for the two patient groups.
- Information provided by patients indicated that the usual care group did not receive treatment that was in accordance with clinical guidelines. This finding was based on a “guideline concordance score” that was calculated to assess how closely the treatments the usual care patients reported receiving were aligned with the guidelines. Reported treatments for most (77%) usual-care patients were at or below a guideline concordance score of 2 out of 8, and none were higher than 4 out of 8.
Conclusions
The researchers conclude that the clinical practice guidelines-based treatment model produces better outcomes for acute low back pain patients, compared with usual care with a family physician.
Future directions
A multicenter clinical trial is now underway.
Publications and conference presentations
Bishop P, Quon J, Olson D, Nixdorf D, Yee B, Fisher C, Dvorak M. A randomized controlled trial on the effectiveness of clinical practice guidelines in the medical and chiropractic management of patients with acute mechanical lower back pain. Can J Surg. Vol. 50, Suppl., Jun 2007:S6-7.
Podium presentation to the Canadian Spine Society, Mont Tremblant, Quebec, February 2007.
Podium presentation to the North American Spine Society, October 2007, Austin, Texas. Abstract Published in the Spine J 2007 (7) 5S p 11.
Podium Presentation to the International Society for the Study of the Lumbar Spine, May 2007, Hong Kong, PRC. Abstract published in the Proc ISSLS 2007 p8.