Low Back Pain, Mechanical — Study Care Versus Usual Care for Acute Mechanical Lower Back Pain
Citation(s)
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.
Study Care Versus Usual Care for Acute Mechanical Lower Back Pain
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.