Multidisciplinary integrative care versus chiropractic care for low back pain: a randomized clinical trial

Gert Bronfort, Michele Maiers, Craig Schulz, Brent Leininger, Kristine Westrom, Greg Angstman, Roni Evans, Gert Bronfort, Michele Maiers, Craig Schulz, Brent Leininger, Kristine Westrom, Greg Angstman, Roni Evans

Abstract

Background: Low back pain (LBP) is influenced by interrelated biological, psychological, and social factors, however current back pain management is largely dominated by one-size fits all unimodal treatments. Team based models with multiple provider types from complementary professional disciplines is one way of integrating therapies to address patients' needs more comprehensively.

Methods: This parallel group randomized clinical trial conducted from May 2007 to August 2010 aimed to evaluate the relative clinical effectiveness of 12 weeks of monodisciplinary chiropractic care (CC), versus multidisciplinary integrative care (IC), for adults with sub-acute and chronic LBP. The primary outcome was pain intensity and secondary outcomes were disability, improvement, medication use, quality of life, satisfaction, frequency of symptoms, missed work or reduced activities days, fear avoidance beliefs, self-efficacy, pain coping strategies and kinesiophobia measured at baseline and 4, 12, 26 and 52 weeks. Linear mixed models were used to analyze outcomes.

Results: 201 participants were enrolled. The largest reductions in pain intensity occurred at the end of treatment and were 43% for CC and 47% for IC. The primary analysis found IC to be significantly superior to CC over the 1-year period (P = 0.02). The long-term profile for pain intensity which included data from weeks 4 through 52, showed a significant advantage of 0.5 for IC over CC (95% CI 0.1 to 0.9; P = 0.02; 0 to 10 scale). The short-term profile (weeks 4 to 12) favored IC by 0.4, but was not statistically significant (95% CI - 0.02 to 0.9; P = 0.06). There was also a significant advantage over the long term for IC in some secondary measures (disability, improvement, satisfaction and low back symptom frequency), but not for others (medication use, quality of life, leg symptom frequency, fear avoidance beliefs, self-efficacy, active pain coping, and kinesiophobia). Importantly, no serious adverse events resulted from either of the interventions.

Conclusions: Participants in the IC group tended to have better outcomes than the CC group, however the magnitude of the group differences was relatively small. Given the resources required to successfully implement multidisciplinary integrative care teams, they may not be worthwhile, compared to monodisciplinary approaches like chiropractic care, for treating LBP. Trial registration NCT00567333.

Keywords: Back pain; Chiropractic; Clinical trial; Integrative medicine; Multidisciplinary.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
CONSORT participant flow
Fig. 2
Fig. 2
Mean Pain Reduction with 95% Confidence Intervals
Fig. 3
Fig. 3
Percent reduction of LBP intensity at week 12
Fig. 4
Fig. 4
Percent reduction of LBP intensity at week 26
Fig. 5
Fig. 5
Percent reduction of LBP intensity at week 52
Fig. 6
Fig. 6
Mean disability reduction with 95% confidence intervals
Fig. 7
Fig. 7
Mean improvement with 95% confidence intervals

References

    1. Hoy D, Bain C, Williams G, March L, Brooks P, Blyth F, Woolf A, Vos T, Buchbinder R. A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012;64(6):2028–2037.
    1. Frymoyer JW. Back pain and sciatica. N Engl J Med. 1988;318(5):291–300.
    1. Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, et al. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014;73(6):968–974.
    1. Chou R, Shekelle P. Will this patient develop persistent disabling low back pain? JAMA. 2010;303(13):1295–1302.
    1. Gore M, Sadosky A, Stacey BR, Tai KS, Leslie D. The burden of chronic low back pain: clinical comorbidities, treatment patterns, and health care costs in usual care settings. Spine. 2012;37(11):E668–677.
    1. Moshfegh J, George SZ, Sun E. Risk and risk factors for chronic opioid use among opioid-naive patients with newly diagnosed musculoskeletal pain in the neck, shoulder, knee, or low back. Ann Intern Med. 2019;170(7):504–505.
    1. Pincus T, Kent P, Bronfort G, Loisel P, Pransky G, Hartvigsen J. Twenty-five years with the biopsychosocial model of low back pain-is it time to celebrate? A report from the twelfth international forum for primary care research on low back pain. Spine. 2013;38(24):2118–2123.
    1. Engel GL. The clinical application of the biopsychosocial model. Am J Psychiatry. 1980;137(5):535–544.
    1. Hartvigsen J, Hancock MJ, Kongsted A, Louw Q, Ferreira ML, Genevay S, Hoy D, Karppinen J, Pransky G, Sieper J, et al. What low back pain is and why we need to pay attention. Lancet. 2018;391(10137):2356–2367.
    1. Buchbinder R, van Tulder M, Oberg B, Costa LM, Woolf A, Schoene M, Croft P. Lancet low back pain series working g: low back pain: a call for action. Lancet. 2018;391(10137):2384–2388.
    1. Mardian AS, Hanson ER, Villarroel L, Karnik AD, Sollenberger JG, Okvat HA, Dhanjal-Reddy A, Rehman S. Flipping the pain care model: a sociopsychobiological approach to high-value chronic pain care. Pain Med 2020.
    1. Lehman BJ, David DM, Gruber JA. Rethinking the biopsychosocial model of health: understanding health as a dynamic system. Soc Personality Psychol Compass 2017;11(8).
    1. Foster NE, Anema JR, Cherkin D, Chou R, Cohen SP, Gross DP, Ferreira PH, Fritz JM, Koes BW, Peul W, et al. Prevention and treatment of low back pain: evidence, challenges, and promising directions. Lancet. 2018;391(10137):2368–2383.
    1. Froud R, Patterson S, Eldridge S, Seale C, Pincus T, Rajendran D, Fossum C, Underwood M. A systematic review and meta-synthesis of the impact of low back pain on people's lives. BMC Musculoskelet Disord. 2014;15:50.
    1. Qaseem A, Wilt TJ, McLean RM, Forciea MA. Clinical Guidelines Committee of the American College of P: noninvasive treatments for acute, subacute, and chronic low back pain: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2017;166(7):514–530.
    1. Mansell G, Hall A, Toomey E. Behaviour change and self-management interventions in persistent low back pain. Best Pract Res Clin Rheumatol. 2016;30(6):994–1002.
    1. Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, Fu R, Dana T, Kraegel P, Griffin J, et al. Nonpharmacologic therapies for low back pain: a systematic review for an American College of Physicians clinical practice guideline. Ann Intern Med. 2017;166(7):493–505.
    1. Skelly AC, Chou R, Dettori JR, Turner JA, Friedly JL, Rundell SD, Fu R, Brodt ED, Wasson N, Kantner S et al. AHRQ comparative effectiveness reviews. In: Noninvasive nonpharmacological treatment for chronic pain: a systematic review update. edn. Rockville (MD): Agency for Healthcare Research and Quality (US); 2020.
    1. Kizhakkeveettil A, Rose K, Kadar GE. Integrative therapies for low back pain that include complementary and alternative medicine care: a systematic review. Glob Adv Health Med. 2014;3(5):49–64.
    1. Kamper SJ, Apeldoorn AT, Chiarotto A, Smeets RJ, Ostelo RW, Guzman J, van Tulder MW. Multidisciplinary biopsychosocial rehabilitation for chronic low back pain. Cochrane Database Syst Rev 2014, 9:CD000963.
    1. Parkin-Smith GF, Amorin-Woods LG, Davies SJ, Losco BE, Adams J. Spinal pain: current understanding, trends, and the future of care. J Pain Res. 2015;8:741–752.
    1. Wayne PM, Eisenberg DM, Osypiuk K, Gow BJ, Witt CM, Davis RB, Buring JE. A multidisciplinary integrative medicine team in the treatment of chronic low-back pain: an observational comparative effectiveness study. J Altern Complement Med. 2018;24(8):781–791.
    1. Maiers MJ, Westrom KK, Legendre CG, Bronfort G. Integrative care for the management of low back pain: use of a clinical care pathway. BMC Health Serv Res. 2010;10:298–298.
    1. Westrom KK, Maiers MJ, Evans RL, Bronfort G. Individualized chiropractic and integrative care for low back pain: the design of a randomized clinical trial using a mixed-methods approach. Trials. 2010;11:24.
    1. Spitzer WO LF, Dupuis M. 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(7 Suppl):S1–59.
    1. Paterson C. Measuring outcomes in primary care: a patient generated measure, MYMOP, compared with the SF-36 health survey. BMJ. 1996;312(7037):1016–1020.
    1. Hoffmann TC, Glasziou PP, Boutron I, Milne R, Perera R, Moher D, Altman DG, Barbour V, Macdonald H, Johnston M et al. Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide. Bmj 2014, 348(mar07 3):g1687.
    1. Jensen MP, Karoly P, Braver S. The measurement of clinical pain intensity: a comparison of six methods. Pain. 1986;27(1):117–126.
    1. Jaeschke R, Singer J, Guyatt GH. A comparison of seven-point and visual analogue scales: data from a randomized trial. Control Clin Trials 1990; 11(1):43–51.
    1. Huskisson EC. Measurement of pain. Lancet. 1974;2(7889):1127–1131.
    1. Carlsson AM. Assessment of chronic pain. I. Aspects of the reliability and validity of the visual analogue scale. Pain 1983, 16(1):87–101.
    1. Patrick DL, Deyo RA, Atlas SJ, Singer DE, Chapin A, Keller RB. Assessing health-related quality of life in patients with sciatica. Spine 1995, 20(17):1899–1908; discussion 1909.
    1. Beurskens AJ, de Vet HC, Koke AJ. Responsiveness of functional status in low back pain: a comparison of different instruments. Pain. 1996;65(1):71–76.
    1. Deyo RA, Walsh NE, Martin DC, Schoenfeld LS, Ramamurthy S. A controlled trial of transcutaneous electrical nerve stimulation (TENS) and exercise for chronic low back pain. N Engl J Med. 1990;322(23):1627–1634.
    1. Kamper SJ, Maher CG, Mackay G. Global rating of change scales: a review of strengths and weaknesses and considerations for design. J Man Manip Ther. 2009;17(3):163–170.
    1. Bronfort G, Evans R, Nelson B, Aker PD, Goldsmith CH, Vernon H: A randomized clinical trial of exercise and spinal manipulation for patients with chronic neck pain. Spine 2001, 26(7):788–797; discussion 798–789.
    1. Shaw JW, Johnson JA, Coons SJ. US valuation of the EQ-5D health states: development and testing of the D1 valuation model. Med Care. 2005;43(3):203–220.
    1. Cherkin DC, Deyo RA, Street JH, Hunt M, Barlow W. Pitfalls of patient education. Limited success of a program for back pain in primary care. Spine 1996, 21(3):345–355.
    1. Bronfort G, Evans RL, Kubic P, Filkin P. Chronic pediatric asthma and chiropractic spinal manipulation: a prospective clinical series and randomized clinical pilot study. J Manipulative Physiol Ther. 2001;24(6):369–377.
    1. Deyo RA, Battie M, Beurskens AJ, Bombardier C, Croft P, Koes B, Malmivaara A, Roland M, Von Korff M, Waddell G. Outcome measures for low back pain research: a proposal for standardized use. Spine. 1998;23(18):2003–2013.
    1. Adams PF, Hendershot GE, Marano MA, Centers for Disease C, Prevention/National Center for Health S. Current estimates from the National Health Interview Survey, 1996. Vital Health Stat 10 1999(200):1–203.
    1. Waddell G, Newton M, Henderson I, Somerville D, Main CJ. A Fear-Avoidance Beliefs Questionnaire (FABQ) and the role of fear-avoidance beliefs in chronic low back pain and disability. Pain. 1993;52(2):157–168.
    1. Nicholas MK. The pain self-efficacy questionnaire: taking pain into account. Eur J Pain. 2007;11(2):153–163.
    1. Carroll L, Mercado AC, Cassidy JD, Cjte P. A population-based study of factors associated with combinations of active and passive coping with neck and low back pain. J Rehabil Med. 2002;34(2):67–72.
    1. Brown GK, Nicassio PM. Development of a questionnaire for the assessment of active and passive coping strategies in chronic pain patients. Pain. 1987;31(1):53–64.
    1. French DJ, France CR, Vigneau F, French JA, Evans RT. Fear of movement/(re)injury in chronic pain: a psychometric assessment of the original English version of the Tampa scale for kinesiophobia (TSK) Pain. 2007;127(1–2):42–51.
    1. Norman G. Likert scales, levels of measurement and the "laws" of statistics. Adv Health Sci Educ Theory Pract. 2010;15(5):625–632.
    1. Levin JR, Serlin RC, Seaman MA. A controlled, powerful multiple-comparison strategy for several situations. Psychol Bull. 1994;115(1):153–159.
    1. Bender R, Lange S. Adjusting for multiple testing–when and how? J Clin Epidemiol. 2001;54(4):343–349.
    1. Fitzmaurice GM, Laird NM, Ware JH. Applied longitudinal analysis: Wiley; 2012.
    1. Pocock SJ, Assmann SE, Enos LE, Kasten LE. Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Stat Med. 2002;21(19):2917–2930.
    1. Diggle P, Heagerty P, Liang K, Zeger S: Analysis of longitudinal data: Oxford University Press; 2002.
    1. Ostelo RW, Deyo RA, Stratford P, Waddell G, Croft P, Von Korff M, 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. 2008;33(1):90–94.
    1. Newcombe RG. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med. 1998;17(8):873–890.
    1. Farrar JT, Dworkin RH, Max MB. Use of the cumulative proportion of responders analysis graph to present pain data over a range of cut-off points: making clinical trial data more understandable. J Pain Symptom Manage. 2006;31(4):369–377.
    1. Bushmakin AG, Cappelleri JC, Zlateva G, Sadosky A. Applying area-under-the-curve analysis to enhance interpretation of response profiles: an application to sleep quality scores in patients with fibromyalgia. Qual Life Res. 2011;20(4):491–498.
    1. Carpenter JR, Kenward MG: Missing data in randomised controlled trials: a practical guide. In.: Health Technology Assessment Methodology Programme; 2007.
    1. Dworkin RH, Turk DC, McDermott MP, Peirce-Sandner S, Burke LB, Cowan P, Farrar JT, Hertz S, Raja SN, Rappaport BA, et al. Interpreting the clinical importance of group differences in chronic pain clinical trials: IMMPACT recommendations. Pain. 2009;146(3):238–244.
    1. Monticone M, Ferrante S, Rocca B, Baiardi P, Farra FD, Foti C. Effect of a long-lasting multidisciplinary program on disability and fear-avoidance behaviors in patients with chronic low back pain: results of a randomized controlled trial. Clin J Pain. 2013;29(11):929–938.
    1. Monticone M, Ambrosini E, Rocca B, Cazzaniga D, Liquori V, Foti C. Group-based task-oriented exercises aimed at managing kinesiophobia improved disability in chronic low back pain. Eur J Pain. 2016;20(4):541–551.
    1. Ronzi Y, Roche-Leboucher G, Begue C, Dubus V, Bontoux L, Roquelaure Y, Richard I, Petit A. Efficiency of three treatment strategies on occupational and quality of life impairments for chronic low back pain patients: is the multidisciplinary approach the key feature to success? Clin Rehabil. 2017;31(10):1364–1373.
    1. Nazzal ME, Saadah MA, Saadah LM, Al-Omari MA, Al-Oudat ZA, Nazzal MS, El-Beshari MY, Al-Zaabi AA, Alnuaimi YI. Management options of chronic low back pain: a randomized blinded clinical trial. Neurosciences (Riyadh) 2013;18(2):152–159.
    1. Tavafian SS, Jamshidi AR, Mohammad K. Treatment of low back pain: randomized clinical trial comparing a multidisciplinary group-based rehabilitation program with oral drug treatment up to 12 months. Int J Rheum Dis. 2014;17(2):159–164.
    1. Linden M, Scherbe S, Cicholas B. Randomized controlled trial on the effectiveness of cognitive behavior group therapy in chronic back pain patients. J Back Musculoskelet Rehabil. 2014;27(4):563–568.
    1. Rantonen J, Karppinen J, Vehtari A, Luoto S, Viikari-Juntura E, Hupli M, Malmivaara A, Taimela S. Effectiveness of three interventions for secondary prevention of low back pain in the occupational health setting - a randomised controlled trial with a natural course control. BMC Public Health. 2018;18(1):598.
    1. Kongsted A, Kent P, Quicke JG, Skou ST, Hill JC: Risk-stratified and stepped models of care for back pain and osteoarthritis: are we heading towards a common model? PAIN Rep. 2020, 5(5):e843.
    1. Di Blasi Z, Harkness E, Ernst E, Georgiou A, Kleijnen J. Influence of context effects on health outcomes: a systematic review. Lancet. 2001;357(9258):757–762.
    1. Bishop FL, Fenge-Davies AL, Kirby S, Geraghty AW. Context effects and behaviour change techniques in randomised trials: a systematic review using the example of trials to increase adherence to physical activity in musculoskeletal pain. Psychol Health. 2015;30(1):104–121.
    1. Veirman E, Van Ryckeghem DML, De Paepe A, Kirtley OJ, Crombez G. Multidimensional screening for predicting pain problems in adults: a systematic review of screening tools and validation studies. Pain Rep. 2019, 4(5):e775.
    1. George SZ, Lentz TA, Beneciuk JM, Bhavsar NA, Mundt JM, Boissoneault J. Framework for improving outcome prediction for acute to chronic low back pain transitions. PAIN Rep. 2020, 5(2):e809.
    1. Leininger B, McDonough C, Evans R, Tosteson T, Tosteson AN, Bronfort G. Cost-effectiveness of spinal manipulative therapy, supervised exercise, and home exercise for older adults with chronic neck pain. Spine J 2016.
    1. Brunner E, De Herdt A, Minguet P, Baldew SS, Probst M. Can cognitive behavioural therapy based strategies be integrated into physiotherapy for the prevention of chronic low back pain? A systematic review. Disabil Rehabil. 2013;35(1):1–10.
    1. Foster NE, Delitto A. Embedding psychosocial perspectives within clinical management of low back pain: integration of psychosocially informed management principles into physical therapist practice–challenges and opportunities. Phys Ther. 2011;91(5):790–803.
    1. George SZ, Teyhen DS, Wu SS, Wright AC, Dugan JL, Yang G, Robinson ME, Childs JD. Psychosocial education improves low back pain beliefs: results from a cluster randomized clinical trial (NCT00373009) in a primary prevention setting. Eur Spine J. 2009;18(7):1050–1058.
    1. Gliedt JA, Schneider MJ, Evans MW, King J, Eubanks JE., Jr The biopsychosocial model and chiropractic: a commentary with recommendations for the chiropractic profession. Chiropr Man Therap. 2017;25:16.
    1. Coupé VMH, van Hooff ML, de Kleuver M, Steyerberg EW, Ostelo R. Decision support tools in low back pain. Best Pract Res Clin Rheumatol. 2016;30(6):1084–1097.
    1. Craig P, Dieppe P, Macintyre S, Michie S, Nazareth I, Petticrew M. Developing and evaluating complex interventions: the new Medical Research Council guidance. Int J Nurs Stud. 2013;50(5):587–592.
    1. Hurley DA, Murphy LC, Hayes D, Hall AM, Toomey E, McDonough SM, Lonsdale C, Walsh NE, Guerin S, Matthews J. Using intervention mapping to develop a theory-driven, group-based complex intervention to support self-management of osteoarthritis and low back pain (SOLAS) Implement Sci. 2016;11(1):56.

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