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The Chiropractic Hospital-based Interventions Research Outcomes (CHIRO) Study: a randomized controlled trial on the effectiveness of clinical practice guidelines in the medical and chiropractic management of patients with acute mechanical low back pain

  • Paul B. Bishop
    Correspondence
    Corresponding author. International Collaboration on Repair Discoveries (ICORD), Blusson Spine Centre, University of British Columbia, 6110-818 West 10th Ave., Vancouver, British Columbia, Canada V5Z 1M9. Tel.: (604) 875-4549; fax: (604) 875-5858.
    Affiliations
    International Collaboration on Repair Discoveries (ICORD), 6110-818 West 10th Ave., University of British Columbia, Vancouver, British Columbia, Canada V5Z 1M9

    Combined Neurosurgical and Orthopaedic Spine Program, Division of Spine, Department of Orthopaedics, Vancouver Hospital and Health Sciences Centre, University of British Columbia, Vancouver, British Columbia, Canada V5Z 1M9
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  • Jeffrey A. Quon
    Affiliations
    School of Population and Public Health, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada V6T 1Z3
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  • Charles G. Fisher
    Affiliations
    International Collaboration on Repair Discoveries (ICORD), 6110-818 West 10th Ave., University of British Columbia, Vancouver, British Columbia, Canada V5Z 1M9

    Combined Neurosurgical and Orthopaedic Spine Program, Division of Spine, Department of Orthopaedics, Vancouver Hospital and Health Sciences Centre, University of British Columbia, Vancouver, British Columbia, Canada V5Z 1M9
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  • Marcel F.S. Dvorak
    Affiliations
    International Collaboration on Repair Discoveries (ICORD), 6110-818 West 10th Ave., University of British Columbia, Vancouver, British Columbia, Canada V5Z 1M9

    Combined Neurosurgical and Orthopaedic Spine Program, Division of Spine, Department of Orthopaedics, Vancouver Hospital and Health Sciences Centre, University of British Columbia, Vancouver, British Columbia, Canada V5Z 1M9
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Published:October 04, 2010DOI:https://doi.org/10.1016/j.spinee.2010.08.019

      Abstract

      Background context

      Evidence-based clinical practice guidelines (CPGs) for the management of patients with acute mechanical low back pain (AM-LBP) have been defined on an international scale. Multicenter clinical trials have demonstrated that most AM-LBP patients do not receive CPG-based treatments. To date, the value of implementing full and exclusively CPG-based treatment remains unclear.

      Purpose

      To determine if full CPGs-based study care (SC) results in greater improvement in functional outcomes than family physician–directed usual care (UC) in the treatment of AM-LBP.

      Study design/setting

      A two-arm, parallel design, prospective, randomized controlled clinical trial using blinded outcome assessment. Treatment was administered in a hospital-based spine program outpatient clinic.

      Patient sample

      Inclusion criteria included patients aged 19 to 59 years with Quebec Task Force Categories 1 and 2 AM-LBP of 2 to 4 weeks’ duration. Exclusion criteria included “red flag” conditions and comorbidities contraindicating chiropractic spinal manipulative therapy (CSMT).

      Outcome measures

      Primary outcome: improvement from baseline in Roland-Morris Disability Questionnaire (RDQ) scores at 16 weeks. Secondary outcomes: improvements in RDQ scores at 8 and 24 weeks; and in Short Form-36 (SF-36) bodily pain (BP) and physical functioning (PF) scale scores at 8, 16, and 24 weeks.

      Methods

      Patients were assessed by a spine physician, then randomized to SC (reassurance and avoidance of passive treatments, acetaminophen, 4 weeks of lumbar CSMT, and return to work within 8 weeks), or family physician–directed UC, the components of which were recorded.

      Results

      Ninety-two patients were recruited, with 36 SC and 35 UC patients completing all follow-up visits. Baseline prognostic variables were evenly distributed between groups. The primary outcome, the unadjusted mean improvement in RDQ scores, was significantly greater in the SC group than in the UC group (p=.003). Regarding unadjusted mean changes in secondary outcomes, improvements in RDQ scores were also greater in the SC group at other time points, particularly at 24 weeks (p=.004). Similarly, improvements in SF-36 PF scores favored the SC group at all time points; however, these differences were not statistically significant. Improvements in SF-36 BP scores were similar between groups. In repeated-measures analyses, global adjusted mean improvement was significantly greater in the SC group in terms of RDQ (p=.0002), nearly significantly greater in terms of SF-36 PF (p=.08), but similar between groups in terms of SF-36 BP (p=.27).

      Conclusions

      This is the first reported randomized controlled trial comparing full CPG-based treatment, including spinal manipulative therapy administered by chiropractors, to family physician–directed UC in the treatment of patients with AM-LBP. Compared to family physician–directed UC, full CPG-based treatment including CSMT is associated with significantly greater improvement in condition-specific functioning.

      Keywords

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      References

        • Bigos S.
        • Bowyer O.
        • Braen G.R.
        • et al.
        Clinical practice guideline number 14: acute low back problems in adults.
        Agency for Health Care Policy and Research, Public Service, US Department of Health and Human Services, Rockville, MD1994 (65-0642)
        • Spitzer W.O.
        • Walter O.
        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: S1-S59
        • Royal College of General Practitioners
        Clinical guidelines for the management of acute low back pain.
        Royal College of General Practitioners, London, UK1999 (Available at:) (Accessed June 4, 2001)
        • Kendall N.A.S.
        • Linton S.J.
        • Main C.J.
        Guide to assessing psychological yellow flags in acute low back pain: risk factors for long-term disability and work loss.
        Accident Rehabilitation & Compensation Insurance Corporation of New Zealand and the National Health Committee, Wellington, NZ1997
        • Abenhaim L.
        • Rossignol M.
        • Valat J.P.
        • 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: 1S-33S
        • Bogduk N.
        Draft evidence based clinical guidelines for the management of acute low back pain.
        National Health and Medical Research Council, Australia2000
        • Central Board of Organization for Peer Review (CBO)
        Consensus Lumbosacral Radicular Syndrome.
        CBO, Utrecht, The Netherlands1995
      1. Treatment guideline–backache. Drug Committee of the German Medical Society.
        [in German] Z Arztl Fortbild Qualitatssich. 1997; 91: 457-460
        • Hansen T.M.
        • Bendix T.
        • Bünger C.E.
        • et al.
        Lower back pain report from the Danish Society of Internal Medicine.
        Ugeskr Laeger. 1996; 158: 1-18
      2. Keel P, Perinin CH, Schutz-Petitjean D, et al. Chronicity of back pain: problematic issues. Final report of program National de Recherche No. 26B. Bale Editions EULAR. 1996.

        • Manniche C.
        • Ankjær-Jensen A.
        • Olsen A.
        • et al.
        Low-back pain: frequency, management and prevention from an HTA perspective.
        Danish Institute for Health Technology Assessment, Copenhagen1999
        • Borkan J.
        • Reis S.
        • Werner S.
        • et al.
        Guidelines for treating low back pain in primary care. The Israeli low back pain guideline group.
        Harefuah. 1996; 130 (224): 145-151
        • Koes B.W.
        • van Tulder M.W.
        • Ostelo R.
        • et al.
        Clinical guidelines for the management of low back pain in primary care: an international comparison.
        Spine. 2001; 26 (discussion 2513–4): 2504-2513
        • Bishop P.B.
        • Wing P.C.
        Compliance with clinical practice guidelines in family physicians managing worker’s compensation board patients with acute lower back pain.
        Spine J. 2003; 3: 442-450
        • Bishop P.B.
        • Wing P.C.
        Knowledge transfer in family physicians managing patients with acute low back pain: a prospective randomized control trial.
        Spine J. 2006; 6: 282-288
        • Gonzalez-Urzelai V.
        • Palacio-Elua L.
        • Lopez-de-Munain J.
        Routine primary care management of acute low back pain: adherence to clinical guidelines.
        Eur Spine J. 2003; 12: 589-594
        • Steven I.D.
        • Fraser R.D.
        Clinical practice guidelines. Particular reference to the management of pain in the lumbosacral spine.
        Spine. 1996; 21: 1593-1596
        • Burton A.K.
        • Waddell G.
        Clinical guidelines in the management of low back pain.
        Baillieres Clin Rheumatol. 1998; 12: 17-35
        • Hart L.G.
        • Deyo R.A.
        • Cherkin D.C.
        Physician office visits for low back pain. Frequency, clinical evaluation, and treatment patterns from a U.S. national survey.
        Spine. 1995; 20: 11-19
        • Cherkin D.C.
        • Deyo R.A.
        • Wheeler K.
        • Ciol M.A.
        Physician views about treating low back pain. The results of a national survey.
        Spine. 1995; 20 (discussion 9–10): 1-10
        • Roland M.
        • Fairbank J.
        The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire.
        Spine. 2000; 25: 3115-3124
        • Bombardier C.
        • Hayden J.
        • Beaton D.E.
        Minimal clinically important 21 difference. Low back pain: outcome measures.
        J Rheumatol. 2001; 28: 431-438
        • Constant F.
        • Collin J.F.
        • Guillemin F.
        • Boulange M.
        Effectiveness of spa therapy in chronic low back pain: a randomized clinical trial.
        J Rheumatol. 1995; 22: 1315-1320
        • McGuirk B.
        • King W.
        • Govind J.
        • 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: 2615-2622
        • UK BEAM Trial Team
        United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary care.
        BMJ. 2004; 329: 1377
        • Hancock M.J.
        • Maher C.G.
        • Latimer J.
        • et al.
        Assessment of diclofenac or spinal manipulative therapy, or both, in addition to recommended first-line treatment for acute low back pain: a randomised controlled trial.
        Lancet. 2007; 370: 1638-1643
        • Suarez-Almazor M.E.
        • Kendall C.
        • Johnson J.A.
        • et al.
        Use of health status measures in patients with low back pain in clinical settings. Comparison of specific, generic and preference-based instruments.
        Rheumatology (Oxford). 2000; 39: 783-790
        • Bishop P.
        • Fisher C.
        • Quon J.
        • Dvorak M.
        Clinical practice guideline-based treatment is not effective for all patients with acute lower back pain: a randomized controlled clinical trial.
        Spine J. 2008; 8: 71S