Advertisement

European Spine Journal

, Volume 17, Issue 7, pp 936–943 | Cite as

Independent evaluation of a clinical prediction rule for spinal manipulative therapy: a randomised controlled trial

  • Mark J. HancockEmail author
  • Christopher G. Maher
  • Jane Latimer
  • Robert D. Herbert
  • James H. McAuley
Original Article

Abstract

A clinical prediction rule to identify patients most likely to respond to spinal manipulation has been published and widely cited but requires further testing for external validity. We performed a pre-planned secondary analysis of a randomised controlled trial investigating the efficacy of spinal manipulative therapy in 239 patients presenting to general practice clinics for acute, non-specific, low back pain. Patients were randomised to receive spinal manipulative therapy or placebo 2 to 3 times per week for up to 4 weeks. All patients received general practitioner care (advice and paracetamol). Outcomes were pain and disability measured at 1, 2, 4 and 12 weeks. Status on the clinical prediction rule was measured at baseline. The clinical prediction rule performed no better than chance in identifying patients with acute, non-specific low back pain most likely to respond to spinal manipulative therapy (pain P = 0.805, disability P = 0.600). At 1-week follow-up, the mean difference in effect of spinal manipulative therapy compared to placebo in patients who were rule positive rather than rule negative was 0.3 points less on a 10-point pain scale (95% CI −0.8 to 1.4). The clinical prediction rule proposed by Childs et al. did not generalise to patients presenting to primary care with acute low back pain who received a course of spinal manipulative therapy.

Keywords

Low back pain Spinal manipulative therapy Subgroup analysis 

Notes

Acknowledgments

The authors acknowledge the assistance of all general medical practitioners and physiotherapists who participated in the trial. We also acknowledge the assistance of Megan Spindler in helping collect much of the data for this trial. Chris Maher and Rob Herbert’s research fellowships and Mark Hancock’s Ph.D. scholarship are funded by Australia’s National Health and Medical Research Council (NHMRC). An NHMRC project grant funded the trial. The funders had no role in the design, conduct, analysis or reporting of the trial.

Supplementary material

586_2008_679_MOESM1_ESM.doc (26 kb)
(DOC 26 kb)

References

  1. 1.
    Assendelft WJJ, Morton SC, Yu EI, Suttorp MJ, Shekelle PG (2004) Spinal manipulative therapy for low back pain. Cochrane Database Syst Rev CD000447Google Scholar
  2. 2.
    Beattie P, Nelson R (2006) Clinical prediction rules: what are they and what do they tell us? Aust J Physiother 52:157–163PubMedGoogle Scholar
  3. 3.
    Bekkering GE, Hendriks HJM, van Tulder MW, Knol DL, Simmonds MJ, Oostendorp RAB et al (2005) Prognostic factors for low back pain in patients referred for physiotherapy: comparing outcomes and varying modeling techniques. Spine 30:1881–1886PubMedCrossRefGoogle Scholar
  4. 4.
    Brookes ST, Whitely E, Egger M, Smith GD, Mulheran PA, Peters TJ (2004) Subgroup analyses in randomized trials: risks of subgroup-specific analyses; power and sample size for the interaction test. J Clin Epidemiol 57:229–236PubMedCrossRefGoogle Scholar
  5. 5.
    Brookes ST, Whitley E, Peters TJ, Mulheran PA, Egger M, Davey Smith G (2001) Subgroup analyses in randomised controlled trials: quantifying the risks of false-positives and false-negatives. Health Technol Assess 5:1–56PubMedGoogle Scholar
  6. 6.
    Childs JD, Cleland JA (2006) Development and application of clinical prediction rules to improve decision making in physical therapist practice. Phys Ther 86:122–131PubMedGoogle Scholar
  7. 7.
    Childs JD, Fritz JM, Flynn TW, Irrgang JJ, Johnson KK, Majkowski GR et al (2004) A clinical prediction rule to identify patients with low back pain most likely to benefit from spinal manipulation: a validation study. Ann Intern Med 141:920–928PubMedGoogle Scholar
  8. 8.
    Croft PR, Dunn KM, Raspe H (2006) Course and prognosis of back pain in primary care: the epidemiological perspective. Pain 122:1–3PubMedCrossRefGoogle Scholar
  9. 9.
    Deyo RA (2004) Treatments for back pain: can we get past trivial effects? Ann Intern Med 141:957–958PubMedGoogle Scholar
  10. 10.
    Flynn T, Fritz J, Whitman J, Wainner R, Magel J, Rendeiro D et al (2002) A clinical prediction rule for classifying patients with low back pain who demonstrate short-term improvement with spinal manipulation. Spine 27:2835–2843PubMedCrossRefGoogle Scholar
  11. 11.
    Fritz JM, Delitto A, Erhard RE (2003) Comparison of classification-based physical therapy with therapy based on clinical practice guidelines for patients with acute low back pain: a randomized clinical trial. Spine 28:1363–1371PubMedCrossRefGoogle Scholar
  12. 12.
    Grieve G (1984) Mobilisation of the spine. Notes on examination, assessment and clinical method, 4th edn. Churchill Livingston, EdinburghGoogle Scholar
  13. 13.
    Grotle M, Brox JI, Veierod MB, Glomsrod B, Lonn JH, Vollestad NK (2005) Clinical course and prognostic factors in acute low back pain: patients consulting primary care for the first time. Spine 30:976–982PubMedCrossRefGoogle Scholar
  14. 14.
    Hancock MJ, Maher CG, Latimer J, McAuley JH (2006) Selecting an appropriate placebo for a trial of spinal manipulative therapy. Aust J Physiother 52:135–138PubMedGoogle Scholar
  15. 15.
    Hancock MJ, Maher CG, Latimer J, McLachlan AJ, Cooper CW, Day RO et al (2007) Addition of diclofenac and/or manipulation to advice and paracetamol does not speed recovery from acute low back pain: a randomised controlled trial. Lancet 370:1638–1643PubMedCrossRefGoogle Scholar
  16. 16.
    Hancock MJ, Maher CG, Latimer J, McLachlan AJ, Cooper CW, Day RO et al (2005) Manipulative therapy and/or NSAIDs for acute low back pain: design of a randomized controlled trial [ACTRN012605000036617]. BMC Musculoskelet Disord 6:57PubMedCrossRefGoogle Scholar
  17. 17.
    Hurley DA, McDonough SM, Baxter GD, Dempster M, Moore AP (2005) A descriptive study of the usage of spinal manipulative therapy techniques within a randomized clinical trial in acute low back pain. Man Ther 10:61–67PubMedCrossRefGoogle Scholar
  18. 18.
    Jull G, Treleaven J, Versace G (1994) Examination of the articular system. In: Boyling JPN (ed) Grieve’s modern manual therapy. The vertebral column, 2nd edn. Churchill Livingston, EdinburghGoogle Scholar
  19. 19.
    Kent P, Keating J (2004) Do primary-care clinicians think that nonspecific low back pain is one condition? Spine 29:1022–1031PubMedCrossRefGoogle Scholar
  20. 20.
    Koes BW, van Tulder MW, Ostelo R, Kim Burton A, Waddell G (2001) Clinical guidelines for the management of low back pain in primary care: an international comparison. Spine 26:2504–2513PubMedCrossRefGoogle Scholar
  21. 21.
    Maitland GD, Hengeveld E, Banks K, English K (2005) Vertebral manipulation, 7th edn. Butterworths, LondonGoogle Scholar
  22. 22.
    McGinn TG, Guyatt GH, Wyer PC, Naylor CD, Stiell IG, Richardson WS (2000) Users’ guides to the medical literature: XXII: how to use articles about clinical decision rules. Evidence-Based Medicine Working Group. JAMA 284:79–84PubMedCrossRefGoogle Scholar
  23. 23.
    Oxman AD, Guyatt GH (1992) A consumer’s guide to subgroup analyses. Ann Intern Med 116:78–84PubMedGoogle Scholar
  24. 24.
    Reilly BM, Evans AT (2006) Translating clinical research into clinical practice: impact of using prediction rules to make decisions. Ann Intern Med 144:201–209PubMedGoogle Scholar
  25. 25.
    Roland M, Morris R (1983) A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine 8(2):141–144PubMedCrossRefGoogle Scholar
  26. 26.
    Team UBT (2004) United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: effectiveness of physical treatments for back pain in primary care. BMJ 329:1377CrossRefGoogle Scholar
  27. 27.
    van Tulder M, Becker A, Bekkering T, Breen A, del Real MTG, Hutchinson A et al (2006) Chapter 3. European guidelines for the management of acute nonspecific low back pain in primary care. Eur Spine J 15(Suppl 2):S169–S191PubMedCrossRefGoogle Scholar
  28. 28.
    Waddell G, Newton M, Henderson I, Somerville D, Main CJ (1993) A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain 52:157–168PubMedCrossRefGoogle Scholar
  29. 29.
    Wand BM, Bird C, McAuley JH, Dore CJ, MacDowell M, De Souza LH (2004) Early intervention for the management of acute low back pain: a single-blind randomized controlled trial of biopsychosocial education, manual therapy, and exercise. Spine 29:2350–2356PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag 2008

Authors and Affiliations

  • Mark J. Hancock
    • 1
    Email author
  • Christopher G. Maher
    • 1
    • 2
  • Jane Latimer
    • 1
    • 2
  • Robert D. Herbert
    • 1
    • 2
  • James H. McAuley
    • 1
    • 2
  1. 1.Back Pain Research Group, Faculty of Health SciencesUniversity of SydneyLidcombeAustralia
  2. 2.Musculoskeletal DivisionThe George Institute for International HealthSydneyAustralia

Personalised recommendations