PRE-ASS ESSMENT. Spinal Manipulation for Lower Back Pain

Transcription

1 PRE-ASS ESSMENT No. 13 Dec 2002 Before decides to undertake a health technology assessment, a pre-assessment of the literature is performed. Pre-assessments are based on a limited literature search; they are not extensive, systematic reviews of the literature. They are provided here as a quick guide to important, current assessment information on this topic. Readers are cautioned that the pre-assessments have not been externally peer reviewed. Introduction Low back pain is experienced by two-thirds of adults during their lifetime. 1 Although roughly 80 percent of primary care patients with low back pain have substantial improvement in the first month regardless of therapy, many continue to experience pain and diminished function. 2,3 Acute and chronic low-back pain represent a major burden in terms of health and costs to society. When specific causes of low-back pain cannot be immediately determined (e.g. infection, neoplasm, sciatica), many interventions are available to the patient. Spinal manipulation, performed by a chiropractor, osteopathic doctor or physiotherapist, is one option. Research Questions The following research questions can be posed: 1. What is the evidence for clinical benefit when spinal manipulation is applied to individuals with low-back pain? 2. Is there evidence of a benefit in terms of cost-effectiveness? Assessment Process PubMed was searched using MeSH headings "Chiropractic", "Manipulation, Spinal" and "Low Back Pain". Retrieval was limited to meta-analyses and systematic reviews. There were 27 hits. A separate PubMed search was conducted using PubMed's own Systematic filter, which yielded an additional 23 hits. A broader search was conducted in the Library, Issue 3, 2002 database using the same MeSH headings and additional keywords such as manual therapy, alternative therapy, etc. Additionally, the MeSH heading "Back Pain" was also used. A parallel search was conducted in the current issue of HEED database to capture economic studies. Web sites and databases of Health Technology Assessment agencies and near-technology Assessment agencies were searched to find completed or in-progress projects on the subject. Internet search engines were used to search for evidence-based guidelines and additional web-based materials/information. Expert Researcher Consulted: Howard Vernon Associate Dean, Research Canadian Memorial Chiropractic College (CMCC) Toronto, Ontario The Canadian Coordinating Office for Health Technology Assessment ()

2 Summary of Findings A large body of literature including randomized trials, systematic reviews, and economic analyses was uncovered during this preliminary search (refer to tables 1-5). In addition, several HTA agencies have conducted evidence-based clinical and economic assessments of this topic (including ). Clinical guidelines were also retrieved. It appears that, for the most part, there is still limited evidence supporting the efficacy and effectiveness of spinal manipulation. The clinical analysis presented by the Collaboration is particularly compelling, as it appears to capture the largest body of evidence and has been ongoing for over 10 years. 4-6 Table 1: Reports by Health Technology Assessment and near Health Technology Assessment Organizations Study Type Analyses Type Conclusions Comments HTAs USA (1999) Danish Health Technology Assessment (1999) ECRI (1997) Sweden (1997) Cost comparison of chiropractic and medical treatment of common muscoskeletal disorders: a review of the literature after 1980 Consensus guidelines Cost benefit analysis of chiropractic and medical episodes of low-back care Cost-effectiveness analysis of chiropractic and physiotherapy treatment Manual treatment can be recommended for patients suffering from acute low-back symptoms and functional limitations of more than 2-3 days duration...and as an element of a broader strategy for low-back trouble N/A To reach the same result after treatment and after six months, the effectiveness and total costs of chiropractic or physiotherapy as primary treatment are similar After considering evidence and cost, therapies recommended were: manual, training/ergonomics, pain medication and exercise therapy The Canadian Coordinating Office for Health Technology Assessment ()

3 NCCHTA (Bristol, 1996) USA (RAND, 1993) (1992) The Swedish Council on Technology Assessment in Health Care (1991) of RCTs for acute and chronic low back pain of clinical and economic evidence There is no conclusive evidence of the effectiveness of manual therapies (for acute LBP), whether in comparison to placebo or other types of interventions The evidence on effectiveness for...chronic LBP is conflicting. The data are insufficient concerning the efficacy of spinal manipulation for chronic lowback pain Chiropractic applied manipulation was at least as effective in treating back pain as the alternative treatments used (in all but one study) Manual treatment of back pain is common, but the few studies in the area have yielded contradictory results Table 2: Guidance Documents Guidelines Analyses Type Conclusions Comments Royal College of General Practitioners (UK, 2001) Evidence based Thirty six RCTs identified: Consider manipulative treatment for patients who need additional help with pain relief or who are failing to return to Institute for Clinical Systems Improvement (USA, 2001) Ontario Treatment Guidelines (2000) New Zealand Acute Low Back Pain Guide (1997) Agency for Health Care Policy and Research (USA, 1994) Consensus based Consensus guidelines Evidence based Evidence based guidelines normal activities Consider referral to chiropractor if failing to make improvement with home self-care after two weeks; or severe or disabling pain; or significant limitation in function. Documented improvement must occur within 3-4 visits Conclusions based on Cherkin study Manipulation recommended in acute uncomplicated conditions Shekelle meta-analysis cited along with 12 RCTs The Canadian Coordinating Office for Health Technology Assessment ()

4 Table 3: Systematic s Systematic s Analyses Type Conclusions Comments Ontario (Institute for Work and Health, 2002) of systematic review, RCTs and CCTs Seven systematic reviews identified (really four after duplicates removed). Unknown effectiveness Cooperstein R (2001) Chiropractic Technique Procedures for Specific Low Back Conditions: Characterizing The Literature Brox JI (1999) [Is exercise therapy and manipulation effective in low back pain?] (Norwegian) Furlan A (1999) Critical literature review of systematic reviews on chronic low back pain Abstr Book Colloq 1999;7:49 Mohseni-Bandpei MA (1998) Spinal manipulation in the treatment of low back pain: a review of the literature with particular emphasis on RCTs Scheer SJ (1997) Randomized controlled trials in industrial low back pain. Part 3. Subacute/chronic pain interventions. Arch Phys Med Rehabil 1997; 78(4): Van der Weide (1997) Vocational Outcomes of Intervention for Low- Back Pain of treatment specific and condition specific trials, studies, and case reports of RCTs in exercise and low back pain of systematic reviews Systematic Systematic from these reports. Side posture adjustments and low back pain were most commonly reported Seven studies evaluated manipulation; the effectiveness was no better than other treatments or placebo Seven systematic reviews studied spinal manipulation/mobilization Twenty five RCTs identified It appears that manipulation may be more effective than other interventions in the treatment of LBP, both in short- and long-terms [sic] effects. N/A For patients with acute low-back pain limited or moderate evidence was found for the efficacy The Canadian Coordinating Office for Health Technology Assessment ()

5 Koes BW Assendelft WJ [in Spine 1996; 21(24): ] Assendelft WJ (1996) The effectiveness of chiropractic for treatment of low back pain: an update and attempt at statistical pooling. Assendelft WJ (1995) The relationship between methodological quality and conclusions in reviews of spinal manipulation Shekelle PG (1992) Spinal manipulation for low-back pain. Ann Intern Med 1992; 117: of RCTs for acute and chronic LBP sensitivity analysis Thirty six RCTs assessed: The efficacy of spinal manipulation for patients with acute or chronic lowerback pain has not been demonstrated with sound randomized clinical trials Because of the great variety of outcome measures and follow-up timing, there was [sic] insufficient data to enable statistical pooling of RCTs Nine out of 10 methodologically best reviews were positive Most current Companion piece to the Companion piece to Anderson R (1992) A meta-analysis of trials of spinal manipulation. J Manipulative Physiol Ther 1992;15 : Assendelft WJ (1992) The efficacy of chiropractic manipulation for back pain: blinded review of relevant randomized clinical trials. J Manipulative Physiol Ther 1992; 15: Koes BW, Assendelft WJ, Spinal manipulation and mobilization for back and neck pain: a blinded review. BMJ 1991; 303: Follow up Original The Canadian Coordinating Office for Health Technology Assessment ()

6 Table 4: Economic Analyses Economic Analyses Analyses Type Conclusions Comments White (2000) Economic analysis of complementary medicine: a systematic review Economic systematic review Except in the case of spinal manipulative therapy the existing economic literature is sparse and of poor quality Cherkin DC (1998) A comparison of physical therapy, chiropractic manipulation, and provision of an educational booklet for the treatment of patients with lower back pain Manga P. University of Ottawa and the Ontario Chiropractic Association (1998) Skargen EI (1998) Cost and effectiveness analysis of chiropractic and physiotherapy treatment for low back and neck pain: 12 month follow up Skargen EI (1997) Cost and effectiveness analysis of chiropractic and physiotherapy treatment for low back and neck pain: six month follow up Smith (1997) Costs and recurrences of chiropractic and medical episodes of low-back care Sullivan MS (1997) Outcomes and costs of health care for low back pain: a comparison of treatment among provider types RCT and costeffectiveness analysis /Costanalysis RCT-based cost and effectiveness analysis RCT-based cost and effectiveness analysis Retrospective cost analysis Cost analysis Mean costs of care were $437 for physical therapy, $429 for chiropractic, and $153 for the booklet. Physical therapy and chiropractic have similar effects on symptoms, function, satisfaction with care, disability, recurrence of back pain, and subsequent visits and were marginally better than booklet therapy. Enhanced coverage of chiropractic services in Ontario (at a cost of $200 million) will lead to a savings of $380 to $770 million Although two groups have broadly similar outcomes, patients with acute uncomplicated problems had better outcomes with (chiropractory) whereas those with chronic problems have better outcomes with (physiotherapy) In terms of both costs and effectiveness there was no statistically significant difference between chiropractic and physiotherapy groups Substantial cost savings with chiropractory This report was funded by the Ontario Chiropractors Association in a bid for receiving public money for service. The Canadian Coordinating Office for Health Technology Assessment ()

7 Stano (1996) Chiropractic and medical costs of low back care Carey TS (1995) The outcomes and costs of care for acute low back pain among patients seen by primary care practitioners, chiropractors, and orthopedic surgeons Turchin PJ (1995) Preliminary findings of analysis of chiropractic utilization and cost in the workers compensation system of New South Wales, Australia Ontario Ministry of Health (1993) Retrospective cost analysis Costeffectiveness analysis from observational cohort Costeffectiveness analysis from observational cohort data /Costanalysis Mean total payments for first episodes of back pain for physicians vs. chrios $1,020 and $558 "No clinical difference in outcomes; patients were more satisfied with chiropractors but primary care physicians provided the least expensive treatment Chiropractic treatment may be associated with fewer days off work due to illness There would be highly significant cost savings if more management of LBP was transferred from medical physicians to chiropractors Pilot study Report with same U of O authors provides no original analysis. Table 5: Other Relevant RCTs And s Andersson GB (1999) A comparison of osteopathic spinal manipulation with standard care for patients with low back pain Bronfort G (1999) Spinal manipulation: current state of research and its indications Carlsson P (1997) The use of cost-effectiveness analysis in the policy-making process in treatment for lowback and neck pain Annu Meet Int Soc Technol Assess Health Care 1997;13:66 Hurwitz EL Medical Versus Chiropractic Care for Patients with Low-Back Pain: Six-Month Follow-Up Outcomes from a Randomized Clinical Trial in a Managed-Care Setting AHSRHP Annu Meet 2000:17 RCT HTA qualitative analysis - narrative RCT No statistically significant differences between groups. Osteopathic care required less medication. There is moderate evidence of short efficacy for spinal manipulation in the treatment of both acute and chronic pain Medical and chiropractic care yielded similar improvements in mean pain severity and disability after six-month of follow-up The Canadian Coordinating Office for Health Technology Assessment ()

8 Conclusion The work on reviewing the clinical evidence is comprehensive and we anticipate the ongoing review to be available in A clinical review in this area would be redundant. A full economic evaluation would not appear to be practical given the difficulty in obtaining primary data. There may, however, be scope for a systematic review of the economic evidence. In 1992 did a review of both the clinical and economic evidence. Since 1992 there have been a number of new economic studies, but no further reviews of economic evidence have been done. Work on an economic review would be subject to the following caveats: 1) Is there an intervention/patient combination where spinal manipulation appears clinically effective? This pre-assessment covers a range of interventions (chiropractor, osteopathic doctor, or physiotherapist), and does not distinguish between acute or chronic back-pain. Evidence of an intervention/patient combination with positive clinical benefit would be needed. 2) What would the relevant comparator be: usual care, other spinal manipulation, watchful waiting? 3) How would an economic review in this area fit with the priorities of and its stakeholders? What is the demand for such a review? 4) A research paper commissioned by the Alberta Health Services Utilization Commission is underway and nearing publication. It may meet the need that this project would fill. ("A systematic review of current knowledge on the effectiveness and cost effectiveness of treatments for low back conditions", Principle Investigator John Church, Faculty of Medicine and Dentistry, University of Alberta.) References 1. Deyo RA, Weinstein JN. Low back pain. N Engl J Med 2001;344(5): Von Korff M, Saunders K. The course of back pain in primary care. Spine 1996;21(24): Deyo RA, Phillips WR. Low back pain. A primary care challenge. Spine 1996;21(24): Assendelft WJ, Koes BW, van der Heijden GJ, Bouter LM. The effectiveness of chiropractic for treatment of low back pain: an update and attempt at statistical pooling. J Manipulative Physiol Ther 1996;19(8): Ernst E, Assendelft WJJ. Chiropractic for low back pain. BMJ 1998;317(7152):160. Available: 6. Breen A, Leerberg E, Pedigo MD, Waddell G, Giles LGF, Ernst E, et al. Chiropractic for low back pain. BMJ 1999;318(7178):261a. Available: The Canadian Coordinating Office for Health Technology Assessment ()