Evaluation of a modified clinical prediction rule for use with spinal manipulative therapy in patients with chronic low back pain: a randomized clinical trial

Paul E Dougherty, Jurgis Karuza, Dorian Savino, Paul Katz, Paul E Dougherty, Jurgis Karuza, Dorian Savino, Paul Katz

Abstract

Background: Spinal Manipulative Therapy (SMT) and Active Exercise Therapy (AET) have both demonstrated efficacy in the treatment of Chronic Lower Back Pain (CLBP). A Clinical Prediction Rule (CPR) for responsiveness to SMT has been validated in a heterogeneous lower back pain population; however there is a need to evaluate this CPR specifically for patients with CLBP, which is a significant source of disability.

Methods: We conducted a randomized controlled trial (RCT) in Veteran Affairs and civilian outpatient clinics evaluating a modification of the original CPR (mCPR) in CLBP, eliminating acute low back pain and altering the specific types of SMT to improve generalizability. We enrolled and followed 181 patients with CLBP from 2007 to 2010. Patients were randomized by status on the mCPR to undergo either SMT or AET twice a week for four weeks. Providers and statisticians were blinded as to mCPR status. We collected outcome measures at 5, 12 and 24-weeks post baseline. We tested our study hypotheses by a general linear model repeated measures procedure following a univariate analysis of covariance approach. Outcome measures included, Visual Analogue Scale, Bodily pain subscale of SF-36 and the Oswestry Disability Index, Patient Satisfaction and Patient Expectation.

Results: Of the 89 AET patients, 69 (78%) completed the study and of the 92 SMT patients, 76 (83%) completed the study. As hypothesized, we found main effects of time where the SMT and AET groups showed significant improvements in pain and disability from baseline. There were no differences in treatment outcomes between groups in response to the treatment, given the lack of significant treatment x time interactions. The mCPR x treatment x time interactions were not significant. The differences in outcomes between treatment groups were the same for positive and negative on the mCPR groups, thus our second hypothesis was not supported.

Conclusions: We found no evidence that a modification of the original CPR can be used to discriminate CLBP patients that would benefit more from SMT. Further studies are needed to further clarify the patient characteristics that moderate treatment responsiveness to specific interventions for CLBP.

Trial registration: ISRCTN30511490.

Keywords: Active exercise therapy; Chronic lower back pain; Clinical prediction rule; Randomized controlled trial; Spinal manipulative therapy.

Figures

Figure 1
Figure 1
Study flow sheet.
Figure 2
Figure 2
Adjusted Outcome Measures. VAS, ODI, and SF-36 Pain Subscale scores, adjusted for age, duration of pain, and treatment site, and 95% confidence intervals at baseline, post treatment 5, 12 and 24-weeks followup. Linear decrease significant for VAS (p = .03), ODI (p = .001) and SF-36 Pain Subscale (p = .002). The larger the score the more pain as measured by the VAS and disability as measured by the ODI. The larger the score the less pain as measured by the SF-36 Pain Subscale.

References

    1. Gironda RJ, Clark ME, Massengale JP, Walker RL. Pain among veterans of operations enduring freedom and Iraqi Freedom. Pain Med. 2006;7:339–343. doi: 10.1111/j.1526-4637.2006.00146.x.
    1. Vos T, Flaxman AD, Naghavi M, Lozano R, Michaud C, Ezzati M, Shibuya K, Salomon JA, Abdalla S, Aboyans V, Abraham J, Ackerman I, Aggarwal R, Ahn SY, Ali MK, Alvarado M, Anderson HR, Anderson LM, Andrews KG, Atkinson C, Baddour LM, Bahalim AN, Barker-Collo S, Barrero LH, Bartels DH, Basanez MG, Baxter A, Bell ML, Benjamin EJ, Bennett D, et al. Years lived with disability (YLDs) for 1160 sequelae of 289 diseases and injuries 1990–2010: a systematic analysis for the Global Burden of Disease Study 2010. Lancet. 2012;380:2163–2196. doi: 10.1016/S0140-6736(12)61729-2.
    1. Deyo RA, Weinstein JN. Low back pain. N Engl J Med. 2001;344:363–370. doi: 10.1056/NEJM200102013440508.
    1. Martin BI, Deyo RA, Mirza SK, Turner JA, Comstock BA, Hollingworth W, Sullivan SD. Expenditures and health status among adults with back and neck problems. JAMA. 2008;299:656–664. doi: 10.1001/jama.299.6.656.
    1. Haldeman S, Dagenais S. A supermarket approach to the evidence-informed management of chronic low back pain. Spine J. 2008;8:1–7. doi: 10.1016/j.spinee.2007.10.009.
    1. Fairbank J, Gwilym SE, France JC, Daffner SD, Dettori J, Hermsmeyer J, Andersson G. The role of classification of chronic low back pain. Spine (Phila Pa 1976 ) 2011;36:S19–S42. doi: 10.1097/BRS.0b013e31822ef72c.
    1. Apkarian AV, Baliki MN, Geha PY. Towards a theory of chronic pain. Prog Neurobiol. 2009;87:81–97. doi: 10.1016/j.pneurobio.2008.09.018.
    1. Grotle M, Foster NE, Dunn KM, Croft P. Are prognostic indicators for poor outcome different for acute and chronic low back pain consulters in primary care? Pain. 2010;151:790–797. doi: 10.1016/j.pain.2010.09.014.
    1. Chou R, Qaseem A, Snow V, Casey D, Cross JT, Jr, Shekelle P, Owens DK. Diagnosis and treatment of low back pain: a joint clinical practice guideline from the American College of Physicians and the American Pain Society. Ann Intern Med. 2007;147:478–491. doi: 10.7326/0003-4819-147-7-200710020-00006.
    1. Chou R, Huffman LH. Nonpharmacologic therapies for acute and chronic low back pain: a review of the evidence for an American Pain Society/American College of Physicians clinical practice guideline. Ann Intern Med. 2007;147:492–504. doi: 10.7326/0003-4819-147-7-200710020-00007.
    1. Hebert J, Koppenhaver S, Fritz J, Parent E. Clinical prediction for success of interventions for managing low back pain. Clin Sports Med. 2008;27:463–479. doi: 10.1016/j.csm.2008.03.002.
    1. Flynn T, Fritz J, Whitman J, Wainner R, Magel J, Rendeiro D, Butler B, Garber M, Allison S. A clinical prediction rule for classifying patients with low back pain who demonstrate short-term improvement with spinal manipulation. Spine (Phila Pa 1976) 2002;27:2835–2843. doi: 10.1097/00007632-200212150-00021.
    1. Childs JD, Fritz JM, Flynn TW, Irrgang JJ, Johnson KK, Majkowski GR, Delitto A. A clinical prediction rule to identify patients with low back pain most likely to benefit from spinal manipulation: a validation study. Ann Intern Med. 2004;141:920–928. doi: 10.7326/0003-4819-141-12-200412210-00008.
    1. Haskins R, Rivett DA, Osmotherly PG. Clinical prediction rules in the physiotherapy management of low back pain: a systematic review. Man Ther. 2012;17:9–21. doi: 10.1016/j.math.2011.05.001.
    1. Patel S, Friede T, Froud R, Evans DW, Underwood M. Systematic review of randomized controlled trials of clinical prediction rules for physical therapy in low back pain. Spine (Phila Pa 1976) 2013;38:762–769. doi: 10.1097/BRS.0b013e31827b158f.
    1. Ohnmeiss DD. Million visual analog scale. In: Gatchel RJ, editor. Compendium of Outcome Instruments for Assessment and Research of Spinal Disorders. La Grange, Illinois: North American Spine Society; 2001. pp. 42–63.
    1. Fairbank JC, Couper J, Davies JB, O'Brien JP. The Oswestry low back pain disability questionnaire. Physiotherapy. 1980;66:271–273.
    1. Sharma S, Firoozi S, McKenna WJ. Value of exercise testing in assessing clinical state and prognosis in hypertrophic cardiomyopathy. Cardiol Rev. 2001;9:70–76. doi: 10.1097/00045415-200103000-00005.
    1. Cherkin DC, Deyo RA, Battie M, Street J, Barlow W. A comparison of physical therapy, chiropractic manipulation, and provision of an educational booklet for the treatment of patients with low back pain. N Engl J Med. 1998;339:1021–1029. doi: 10.1056/NEJM199810083391502.
    1. Bronfort G, Goldsmith CH, Nelson CF, Boline PD, Anderson AV. Trunk exercise combined with spinal manipulative or NSAID therapy for chronic low back pain: a randomized, observer-blinded clinical trial. J Manipulative Physiol Ther. 1996;19:570–582.
    1. Christensen MG, Kollasch MW, Ward R, Webb KR, Day AA, zumBrunnen J. Job Analysis of Chiropractic: a project report, survey anlaysis, and summary of the practice of chiropractic within the United States. Greeley: National Board of Chiropractic Examiners; 2005.
    1. O'Sullivan PB, Phyty GD, Twomey LT, Allison GT. Evaluation of specific stabilizing exercise in the treatment of chronic low back pain with radiologic diagnosis of spondylolysis or spondylolisthesis. Spine (Phila Pa 1976) 1997;22:2959–2967. doi: 10.1097/00007632-199712150-00020.
    1. Hides JA, Jull GA, Richardson CA. Long-term effects of specific stabilizing exercises for first-episode low back pain. Spine (Phila Pa 1976) 2001;26:E243–E248. doi: 10.1097/00007632-200106010-00004.
    1. Wilke HJ, Wolf S, Claes LE, Arand M, Wiesend A. Stability increase of the lumbar spine with different muscle groups. A biomechanical in vitro study. Spine (Phila Pa 1976) 1995;20:192–198. doi: 10.1097/00007632-199501150-00011.
    1. Haas M, Groupp E, Kraemer DF. Dose–response for chiropractic care of chronic low back pain. Spine J. 2004;4:574–583. doi: 10.1016/j.spinee.2004.02.008.
    1. McHorney CA, Ware JE, Jr, Raczek AE. The MOS 36-Item Short-Form Health Survey (SF-36): II. Psychometric and clinical tests of validity in measuring physical and mental health constructs. Med Care. 1993;31:247–263. doi: 10.1097/00005650-199303000-00006.
    1. Hertzman-Miller RP, Morgenstern H, Hurwitz EL, Yu F, Adams AH, Harber P, Kominski GF. Comparing the satisfaction of low back pain patients randomized to receive medical or chiropractic care: results from the UCLA low-back pain study. Am J Public Health. 2002;92:1628–1633. doi: 10.2105/AJPH.92.10.1628.
    1. Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von KM, Bouter LM, de Vet HC. Interpreting change scores for pain and functional status in low back pain: towards international consensus regarding minimal important change. Spine (Phila Pa 1976) 2008;33:90–94. doi: 10.1097/BRS.0b013e31815e3a10.
    1. Iles RA, Davidson M, Taylor NF, O'Halloran P. Systematic review of the ability of recovery expectations to predict outcomes in non-chronic non-specific low back pain. J Occup Rehabil. 2009;19:25–40. doi: 10.1007/s10926-008-9161-0.
    1. Hurwitz EL. Commentary: exercise and spinal manipulative therapy for chronic low back pain: time to call for a moratorium on future randomized trials? Spine J. 2011;11:599–600. doi: 10.1016/j.spinee.2011.04.021.
    1. Rubinstein SM, Van MM, Assendelft WJ, De Boer MR, Van Tulder MW. Spinal manipulative therapy for chronic low-back pain: an update of a Cochrane review. Spine (Phila Pa 1976) 2011;36:E825–E846. doi: 10.1097/BRS.0b013e3182197fe1.
    1. Gore M, Tai KS, Sadosky A, Leslie D, Stacey BR. Clinical comorbidities, treatment patterns, and direct medical costs of patients with osteoarthritis in usual care: a retrospective claims database analysis. J Med Econ. 2011;14:497–507.
    1. Kent P, Mjosund HL, Petersen DH. Does targeting manual therapy and/or exercise improve patient outcomes in nonspecific low back pain? A systematic review. BMC Med. 2010;8:22. doi: 10.1186/1741-7015-8-22.
    1. Hebert JJ, Koppenhaver SL, Walker BF. Subgrouping patients with low back pain: a treatment-based approach to classification. Sports Health. 2011;3:534–542. doi: 10.1177/1941738111415044.
    1. Hancock MJ, Maher CG, Latimer J, Herbert RD, McAuley JH. Independent evaluation of a clinical prediction rule for spinal manipulative therapy: a randomised controlled trial. Eur Spine J. 2008;17:936–943. doi: 10.1007/s00586-008-0679-9.
    1. Ramond A, Bouton C, Richard I, Roquelaure Y, Baufreton C, Legrand E, Huez JF. Psychosocial risk factors for chronic low back pain in primary care–a systematic review. Fam Pract. 2011;28:12–21. doi: 10.1093/fampra/cmq072.
    1. Kongsted A, Johannesen E, Leboeuf-Yde C. Feasibility of the STarT back screening tool in chiropractic clinics: a cross-sectional study of patients with low back pain. Chiropr Man Therap. 2011;19:10. doi: 10.1186/2045-709X-19-10.
    1. Hill JC, Whitehurst DG, Lewis M, Bryan S, Dunn KM, Foster NE, Konstantinou K, Main CJ, Mason E, Somerville S, Sowden G, Vohora K, Hay EM. Comparison of stratified primary care management for low back pain with current best practice (STarT Back): a randomised controlled trial. Lancet. 2011;378:1560–1571. doi: 10.1016/S0140-6736(11)60937-9.
    1. Grotle M, Vollestad NK, Brox JI. Clinical course and impact of fear-avoidance beliefs in low back pain: prospective cohort study of acute and chronic low back pain: II. Spine (Phila Pa 1976) 2006;31:1038–1046. doi: 10.1097/01.brs.0000214878.01709.0e.
    1. Haas M, Vavrek D, Peterson D, Polissar N, Neradilek MB. Dose–response and efficacy of spinal manipulation for care of chronic low back pain: a randomized controlled trial. Spine J. 2014;14:1106–1116. doi: 10.1016/j.spinee.2013.07.468.
    1. Bronfort G, Maiers MJ, Evans RL, Schulz CA, Bracha Y, Svendsen KH, Grimm RH, Jr, Owens EF, Jr, Garvey TA, Transfeldt EE. Supervised exercise, spinal manipulation, and home exercise for chronic low back pain: a randomized clinical trial. Spine J. 2011;11:585–598. doi: 10.1016/j.spinee.2011.01.036.
    1. Steiger F, Wirth B, de Bruin ED, Mannion AF. Is a positive clinical outcome after exercise therapy for chronic non-specific low back pain contingent upon a corresponding improvement in the targeted aspect(s) of performance? A systematic review. Eur Spine J. 2012;21:575–598. doi: 10.1007/s00586-011-2045-6.
    1. Machado LA, Kamper SJ, Herbert RD, Maher CG, McAuley JH. Analgesic effects of treatments for non-specific low back pain: a meta-analysis of placebo-controlled randomized trials. Rheumatology (Oxford) 2009;48:520–527. doi: 10.1093/rheumatology/ken470.
    1. Fregni F, Imamura M, Chien HF, Lew HL, Boggio P, Kaptchuk TJ, Riberto M, Hsing WT, Battistella LR, Furlan A. Challenges and recommendations for placebo controls in randomized trials in physical and rehabilitation medicine: a report of the international placebo symposium working group. Am J Phys Med Rehabil. 2010;89:160–172. doi: 10.1097/PHM.0b013e3181bc0bbd.
    1. Dougherty P, Karuza J, Dunn A, Savino D, Katz P: Spinal manipulative therapy for chronic lower back pain in older veteran's: a prospective, randomized, placebo-controlled trial.Geriatric Orthopaedic Surgery and Rehabilitation in press.

Source: PubMed

Sponsors en medewerkers

Medische omstandigheden

Geneesmiddelinterventies

3
Abonneren