Study Care Versus Usual Care for Acute Mechanical Lower Back Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00135239
Recruitment Status : Completed
First Posted : August 25, 2005
Last Update Posted : June 17, 2008
Information provided by:
University of British Columbia

Brief Summary:
The most common work-related injury in British Columbia every year is a lower back injury. The many different treatment options that are available to workers with a back injury have often led to confusion and frustration. New back pain research has shown which combinations of treatments are most helpful, but has also shown that many injured workers in British Columbia do not have these treatments made readily available to them. This research study is designed to accurately determine whether or not providing patients suffering from acute back injuries with a combination of all of these recommended treatments, will improve their function, quality of life and return to work.

Condition or disease Intervention/treatment Phase
Low Back Pain, Mechanical Procedure: Study care Procedure: Usual care Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Study Care Versus Usual Care for Acute Mechanical Lower Back Pain
Study Start Date : January 2006
Actual Primary Completion Date : June 2008
Actual Study Completion Date : June 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Intervention Details:
  • Procedure: Study care
    All study patients will be assessed initially by a physician in the CNOSP outpatient clinic to confirm that they meet the inclusion/exclusion criteria of the study. Patients receiving the EBC intervention will then receive re-assurance, advice to avoid passive treatments, acetominophen (except where contraindicated) for a period of 2-4 weeks, a four week course of lumbar spine spinal manipulative therapy administered by a CNOSP Chiropractor and advice to return to work in some capacity within eight weeks following the start of treatment. Patients randomized to the UC treatment arm will undergo the treatment(s) recommended by their family physicians.
  • Procedure: Usual care
    Patients randomized to the UC treatment arm will undergo the treatment(s) recommended by their family physicians.

Primary Outcome Measures :
  1. To determine if study-based care (SC) is more effective than usual care (UC) in the treatment of patients with acute mechanical lower back pain after 16 weeks [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. To determine if SC is more effective than UC in improving the functional status of patients with acute mechanical lower back pain at 8 weeks and 24 weeks. [ Time Frame: 24 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Residents of British Columbia with mechanical lower back pain
  • Acute lower back pain with symptoms lasting 2-4 weeks
  • Satisfy the Quebec Task Force Classification of Spinal Disorders Categories 1 and 2

Exclusion Criteria:

  • Other significant spinal pathology
  • Pregnancy
  • Patients with Workers' Compensation Board (WCB) claims
  • Persistent pain in other areas of the spine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00135239

Canada, British Columbia
Medical Rapid Access Spine Clinic
Vancouver, British Columbia, Canada, V5Z 3J5
Sponsors and Collaborators
University of British Columbia
Principal Investigator: Dr. Paul Bishop, MD University of British Columbia

1. Bigos, S.J.B., O.R.; Braen, G.R.; et al., Clinical practice guideline number 4: Acute low back problems in adults. 1994, Agency for Health Care Policy and Research, Public Service, US Department of Health and Human Services: Rockville, MD. p. 65-0642. 2. Spitzer, W.O., et al., Scientific approach to the assessment and management of activity-related spinal disorders. A monograph for clinicians. Report of the Quebec Task Force on Spinal Disorders. Spine, 1987. 12 (suppl)(7): p. S1-59. 3. Practitioners, R.C.o.G., Clinical guidelines for the management of low back pain. Accessed April 6, 2001. 4. Kendall, N.A., Linton, S.J., Main, C.J., Guide to assessing psychosocial yellow flags in acute low back pain: risk factors for long-term disability and work loss. 1997, Accident Rehabilitation and Compensation Insurance Corporation of New Zealand and the National Health Committee.: Wellington (NZ). 5. Abenhaim, L., et al., The role of activity in the therapeutic management of back pain. Report of the International Paris Task Force on Back Pain. Spine, 2000. 25(4 Suppl): p. 1S-33S. 6. Bogduk, N., Draft evidence based clinical guidelines for the management of acute low back pain. 2000, National Health and Medical Research Council: Australia. 7. (CBO), C.B.v.d.I.T., Consensus Lumbosacrale Radicular Syndrome. June 1995: Utrecht. 8. Ruckenschmerzen, H.-. Empfehlungen zur Therapie von Ruckenschmerzen, Artzneimittelkommission der deutschen Arzteschaft (Treatment guidelines - backache. Drug Committee of German Medical Society). Z Artztl Fortbild Qualitatssich. 1997(91): p. 457-460. 9. Hansen, T.M., Bendix, T., Bunger, C.D., et al., Laenderesmerter Klaringsrapport fra dansk selskap for intern medecin. Ugeskr Laeger, 1996. 158(14 (Suppl)): p. 1-18. 10. Keel, P., Perinin, C.H., Schutz-Petitjean, D., et al., Chronicisation des douleurs du dos: Problematique issues. Rapport final du Programme National de Recherche No. 26B. Bale Editions EULAR. 1996. 11. Manniche, C., ed. Low back pain: Frequency, management and prevention from HTA perspective. 1999, Danish Institute for Health Technology Assessment. 12. Borkan, J., Reis, S., Werner, S. et al., Guidelines for treating low back pain in primary care. 1996, The Israeli Low Back Pain Guideline Group. p. 130: 145-51. 13. Koes, B.W., et al., Clinical guidelines for the management of low back pain in primary care: an international comparison. Spine, 2001. 26(22): p. 2504-13; discussion 2513-4. 14. Hayward, R.S., et al., Canadian physicians' attitudes about and preferences regarding clinical practice guidelines. Cmaj, 1997. 156(12): p. 1715-23. 15. Hayward, R.S., Clinical practice guidelines on trial. Cmaj, 1997. 156(12): p. 1725-7. 16. Basinski, A.S., Evaluation of clinical practice guidelines. Cmaj, 1995. 153(11): p. 1575-81. 17. Steven, I.D. and R.D. Fraser, Clinical practice guidelines. Particular reference to the management of pain in the lumbosacral spine. Spine, 1996. 21(13): p. 1593-6. 18. Burton, A.K. and G. Waddell, Clinical guidelines in the management of low back pain. Baillieres Clin Rheumatol, 1998. 12(1): p. 17-35. 19. Hart, L.G., R.A. Deyo, and D.C. Cherkin, Physician office visits for low back pain. Frequency, clinical evaluation, and treatment patterns from a U.S. national survey. Spine, 1995. 20(1): p. 11-9. 20. Cherkin, D.C., et al., Physician views about treating low back pain. The results of a national survey. Spine, 1995. 20(1): p. 1-9; discussion 9-10. 21. Bishop, P.B. and P.C. Wing, Compliance with clinical practice guidelines in family physicians managing worker's compensation board patients with acute lower back pain. Spine J, 2003. 3(6): p. 442-50. 22. Gonzalez-Urzelai V, P.-E.L., Lopez-de-Munain J, Routine primary care management of acute lower back pain: adherence to guidelines. Eur Spine J, 2003. 12: p. 589-594. 23. Bishop, P., Badii, M., Wing, P., Implementation of clinical practice guidelines in workers compensation board patients with acute mechanical back pain: a prospective randomized trial. Proceedings of the North American Spine Society 17th Annual Meeting. Spine Journal, 2002. 2: p. 62-63S. 24. Bishop, P.W., PC, The Implementation of Clinical Practice Guidelines in Family Physicians Managing Workers' Compensation Board Patients with Acute Lower Back Pain Using Patient Specific Direct Physician to Physician Communication: A Prospective Randomized Trial. Spine, 2003. Submitted. 25. McGuirk, B., et al., Safety, efficacy, and cost effectiveness of evidence-based guidelines for the management of acute low back pain in primary care. Spine, 2001. 26(23): p. 2615-22.

Responsible Party: Dr. Paul Bishop, University of British Columbia Identifier: NCT00135239     History of Changes
Other Study ID Numbers: C04-0588
First Posted: August 25, 2005    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008

Keywords provided by University of British Columbia:
Lower Mechanical Back Pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms