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Chiropractic & Manual Therapies
Published in: Chiropractic & Manual Therapies 1/2018

Open Access 01-12-2018 | Study protocol

Cost-effectiveness of spinal manipulation, exercise, and self-management for spinal pain using an individual participant data meta-analysis approach: a study protocol

Authors: Brent Leininger, Gert Bronfort, Roni Evans, James Hodges, Karen Kuntz, John A. Nyman

Published in: Chiropractic & Manual Therapies | Issue 1/2018

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Abstract

Background

Spinal pain is a common and disabling condition with considerable socioeconomic burden. Spine pain management in the United States has gathered increased scrutiny amidst concerns of overutilization of costly and potentially harmful interventions and diagnostic tests. Conservative interventions such as spinal manipulation, exercise and self-management may provide value for the care of spinal pain, but little is known regarding the cost-effectiveness of these interventions in the U.S. Our primary objective for this project is to estimate the incremental cost-effectiveness of spinal manipulation, exercise therapy, and self-management for spinal pain using an individual patient data meta-analysis approach.

Methods/design

We will estimate the incremental cost-effectiveness of spinal manipulation, exercise therapy, and self-management using cost and clinical outcome data collected in eight randomized clinical trials performed in the U.S. Cost-effectiveness will be assessed from both societal and healthcare perspectives using QALYs, pain intensity, and disability as effectiveness measures. The eight randomized clinical trials used similar methods and included different combinations of spinal manipulation, exercise therapy, or self-management for spinal pain. They also collected similar clinical outcome, healthcare utilization, and work productivity data. A two-stage approach to individual patient data meta-analysis will be conducted.

Discussion

This project capitalizes on a unique opportunity to combine clinical and economic data collected in a several clinical trials that used similar methods. The findings will provide important information on the value of spinal manipulation, exercise therapy, and self-management for spinal pain management in the U.S.
Literature
1.
Institute of Medicine. Relieving pain in America: a blueprint for transforming prevention, care, education, and research. Washington, DC: The National Academies Press; 2011.
2.
Johannes CB, Le TK, Zhou X, Johnston JA, Dworkin RH. The prevalence of chronic pain in United States adults: results of an internet-based survey. J Pain. 2010;11(11):1230–9.CrossRefPubMed
3.
Von Korff M, Crane P, Lane M, Miglioretti DL, Simon G, Saunders K, Stang P, Brandenburg N, Kessler R. Chronic spinal pain and physical-mental comorbidity in the United States: results from the national comorbidity survey replication. Pain. 2005;113(3):331–9.CrossRefPubMed
4.
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):968–74.CrossRefPubMed
5.
Hoy D, March L, Woolf A, Blyth F, Brooks P, Smith E, Vos T, Barendregt J, Blore J, Murray C, et al. The global burden of neck pain: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014;73(7):1309–15.CrossRefPubMed
6.
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(6):656–64.CrossRefPubMed
7.
Dieleman JL, Baral R, Birger M, Bui AL, Bulchis A, Chapin A, Hamavid H, Horst C, Johnson EK, Joseph J, et al. US spending on personal health care and public health, 1996-2013. JAMA. 2016;316(24):2627–46.CrossRefPubMedPubMedCentral
8.
Stewart WF, Ricci JA, Chee E, Morganstein D, Lipton R. Lost productive time and cost due to common pain conditions in the US workforce. JAMA. 2003;290(18):2443–54.CrossRefPubMed
9.
10.
Pinto RZ, Maher CG, Ferreira ML, Hancock M, Oliveira VC, McLachlan AJ, Koes B, Ferreira PH. Epidural corticosteroid injections in the management of sciatica: a systematic review and meta-analysis. Ann Intern Med. 2012;157(12):865–77.CrossRefPubMed
11.
Deshpande A, Furlan A, Mailis-Gagnon A, Atlas S, Turk D. Opioids for chronic low-back pain. Cochrane Database Syst Rev. 2007;3:CD004959.
12.
Staal JB, de Bie R, de Vet HC, Hildebrandt J, Nelemans P. Injection therapy for subacute and chronic low-back pain. Cochrane Database Syst Rev. 2008;3:CD001824.
13.
14.
Davis MA, Onega T, Weeks WB, Lurie JD. Where the United States spends its spine dollars: expenditures on different ambulatory services for the management of back and neck conditions. Spine. 2012;37(19):1693–701.CrossRefPubMedPubMedCentral
15.
Ivanova JI, Birnbaum HG, Schiller M, Kantor E, Johnstone BM, Swindle RW. Real-world practice patterns, health-care utilization, and costs in patients with low back pain: the long road to guideline-concordant care. Spine J. 2011;11(7):622–32.CrossRefPubMed
16.
Martin BI, Gerkovich MM, Deyo RA, Sherman KJ, Cherkin DC, Lind BK, Goertz CM, Lafferty WE. The association of complementary and alternative medicine use and health care expenditures for back and neck problems. Med Care. 2012;50(12):1029–36.CrossRefPubMedPubMedCentral
17.
Andronis L, Kinghorn P, Qiao S, Whitehurst DG, Durrell S, McLeod H. Cost-effectiveness of non-invasive and non-pharmacological interventions for low back pain: a systematic literature review. Appl Health Econ Health Policy. 2017;15(2):173–201.CrossRefPubMed
18.
Tsertsvadze A, Clar C, Court R, Clarke A, Mistry H, Sutcliffe P. Cost-effectiveness of manual therapy for the management of musculoskeletal conditions: a systematic review and narrative synthesis of evidence from randomized controlled trials. J Manip Physiol Ther. 2014;37(6):343–62.CrossRef
19.
Rubinstein SM, van Middelkoop M, Assendelft WJ, de Boer MR, van Tulder MW. Spinal manipulative therapy for chronic low-back pain. Cochrane Database Syst Rev. 2011;2:CD008112.
20.
Michaleff ZA, Lin CW, Maher CG, van Tulder MW. Spinal manipulation epidemiology: systematic review of cost effectiveness studies. J Electromyogr Kinesiol. 2012;22(5):655–62.CrossRefPubMed
21.
Herman PM, Poindexter BL, Witt CM, Eisenberg DM. Are complementary therapies and integrative care cost-effective? A systematic review of economic evaluations. BMJ Open. 2012;2:5.CrossRef
22.
Evans R, Bronfort G, Schulz C, Maiers M, Bracha Y, Svendsen K, Grimm R, Garvey T, Transfeldt E. Supervised exercise with and without spinal manipulation performs similarly and better than home exercise for chronic neck pain: a randomized controlled trial. Spine. 2012;37(11):903–14.CrossRefPubMed
23.
Maiers M, Bronfort G, Evans R, Hartvigsen J, Svendsen K, Bracha Y, Schulz C, Schulz K, Grimm R. Spinal manipulative therapy and exercise for seniors with chronic neck pain. Spine J. 2014;14(9):1879–89.CrossRefPubMed
24.
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(7):585–598.
25.
Maiers MJ, Hartvigsen J, Schulz C, Schulz K, Evans RL, Bronfort G. Chiropractic and exercise for seniors with low back pain or neck pain: the design of two randomized clinical trials. BMC Musculoskelet Disord. 2007;8(1):94.CrossRefPubMedPubMedCentral
26.
Bronfort G, Hondras MA, Schulz CA, Evans RL, Long CR, Grimm R. Spinal manipulation and home exercise with advice for subacute and chronic back-related leg pain: a trial with adaptive allocation. Ann Intern Med. 2014;161(6):381–91.CrossRefPubMed
27.
Schulz C, Leininger B, Evans R, Vavrek D, Peterson D, Haas M, Bronfort G. Spinal manipulation and exercise for low back pain in adolescents: study protocol for a randomized controlled trial. Chiropr Man Therap. 2014;22:21.CrossRefPubMedPubMedCentral
28.
Bronfort G, Evans R, Anderson AV, Svendsen KH, Bracha Y, Grimm RH. Spinal manipulation, medication, or home exercise with advice for acute and subacute neck pain: a randomized trial. Ann Intern Med. 2012;156(1.1):1–10.CrossRefPubMed
29.
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):788–97. discussion 798-789CrossRefPubMed
30.
Neumann PJ, Sanders GD, Russell LB, Siegel JE, Ganiats TG. Cost-effectiveness in health and medicine. New York: Oxford University Press; 2016.CrossRef
31.
Brazier J, Roberts J, Deverill M. The estimation of a preference-based measure of health from the SF-36. J Health Econ. 2002;21(2):271–92.CrossRefPubMed
32.
Craig BM, Pickard AS, Stolk E, Brazier JE. US valuation of the SF-6D. Med Decis Mak. 2013;33(6):793–803.CrossRef
33.
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):203–20.CrossRefPubMed
34.
Khan KA, Petrou S, Rivero-Arias O, Walters SJ, Boyle SE. Mapping EQ-5D utility scores from the PedsQL generic core scales. PharmacoEconomics. 2014;32(7):693–706.CrossRefPubMed
35.
Dworkin RH, Turk DC, Farrar JT, Haythornthwaite JA, Jensen MP, Katz NP, Kerns RD, Stucki G, Allen RR, Bellamy N, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommendations. Pain. 2005;113(1–2):9–19.CrossRefPubMed
36.
Deyo RA, Dworkin SF, Amtmann D, Andersson G, Borenstein D, Carragee E, Carrino J, Chou R, Cook K, DeLitto A, et al. Report of the NIH task force on research standards for chronic low back pain. J Pain. 2014;15(6):569–85.CrossRefPubMedPubMedCentral
37.
Vernon H, Mior S. The neck disability index: a study of reliability and validity. J Manip Physiol Ther. 1991;14(7):409–15.
38.
van der Velde G, Beaton D, Hogg-Johnston S, Hurwitz E, Tennant A. Rasch analysis provides new insights into the measurement properties of the neck disability index. Arthritis Rheum. 2009;61(4):544–51.CrossRefPubMed
39.
Roland M, Fairbank J: The Roland-Morris disability questionnaire and the Oswestry disability questionnaire. Spine 2000, 25(24):3115–3124.
40.
Higgins JPT, Green S: Cochrane handbook for systematic reviews of interventions Version 5.1.0 [updated March 2011]. In: The Cochrane Collaboration. 2011: Available from www.cochrane-Available from handbook.org.
41.
Krol M, Brouwer W, Rutten F. Productivity costs in economic evaluations: past, present, future. PharmacoEconomics. 2013;31(7):537–49.CrossRefPubMed
42.
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.
43.
Probst JC, Laditka SB, Wang JY, Johnson AO. Effects of residence and race on burden of travel for care: cross sectional analysis of the 2001 US National Household Travel Survey. BMC Health Serv Res. 2007;7:40.CrossRefPubMedPubMedCentral
44.
Mihaylova B, Briggs A, O'Hagan A, Thompson SG. Review of statistical methods for analysing healthcare resources and costs. Health Econ. 2011;20(8):897–916.CrossRefPubMed
45.
Hunink M, Weinstein M, Wittenberg E, Drummond M, Pliskin J, Wong J, Glasziou P. Decision making in health and medicine: integrating evidence and values. Cambridge: Cambridge University Press; 2014.CrossRef
46.
Briggs AH, O'Brien BJ, Blackhouse G. Thinking outside the box: recent advances in the analysis and presentation of uncertainty in cost-effectiveness studies. Annu Rev Public Health. 2002;23:377–401.CrossRefPubMed
47.
Fenwick E, O'Brien BJ, Briggs A. Cost-effectiveness acceptability curves--facts, fallacies and frequently asked questions. Health Econ. 2004;13(5):405–15.CrossRefPubMed
48.
Groot Koerkamp B, Hunink MG, Stijnen T, Hammitt JK, Kuntz KM, Weinstein MC. Limitations of acceptability curves for presenting uncertainty in cost-effectiveness analysis. Med Decis Mak. 2007;27(2):101–11.CrossRef
49.
Briggs A, Clark T, Wolstenholme J, Clarke P. Missing... Presumed at random: cost-analysis of incomplete data. Health Econ. 2003;12(5):377–92.CrossRefPubMed
50.
Diggle P, Heagerty P, Liang K, Zeger S. Analysis of longitudinal data. Oxford: Oxford University press; 2002.
51.
Stewart GB, Altman DG, Askie LM, Duley L, Simmonds MC, Stewart LA. Statistical analysis of individual participant data meta-analyses: a comparison of methods and recommendations for practice. PLoS One. 2012;7(10):e46042.CrossRefPubMedPubMedCentral
52.
Riley RD, Lambert PC, Abo-Zaid G. Meta-analysis of individual participant data: rationale, conduct, and reporting. BMJ. 2010;340:c221.CrossRefPubMed
53.
Guyatt GH, Oxman AD, Kunz R, Woodcock J, Brozek J, Helfand M, Alonso-Coello P, Glasziou P, Jaeschke R, Akl EA, et al. GRADE guidelines: 7. Rating the quality of evidence--inconsistency. J Clin Epidemiol. 2011;64(12):1294–302.CrossRefPubMed
54.
AHRQ Methods for Effective Health Care. In: Methods Guide for Effectiveness and Comparative Effectiveness Reviews. Edn. Rockville (MD): Agency for Healthcare Research and Quality (US); 2014.
55.
Espinoza MA, Manca A, Claxton K, Sculpher MJ. The value of heterogeneity for cost-effectiveness subgroup analysis: conceptual framework and application. Med Decis Mak. 2014;34(8):951–64.CrossRef
56.
Shemilt I, McDaid D, Marsh K, Henderson C, Bertranou E, Mallander J, Drummond M, Mugford M, Vale L, Campbell and Cochrane Economics Methods Group, et al. Issues in the incorporation of economic perspectives and evidence into Cochrane reviews. Syst Rev. 2013;2:83.CrossRefPubMedPubMedCentral
57.
Brunetti M, Shemilt I, Pregno S, Vale L, Oxman AD, Lord J, Sisk J, Ruiz F, Hill S, Guyatt GH, et al. GRADE guidelines: 10. Considering resource use and rating the quality of economic evidence. J Clin Epidemiol. 2013;66(2):140–50.CrossRefPubMed
58.
Korthals-de Bos IB, Hoving JL, van Tulder MW, Rutten-van Molken MP, Ader HJ, de Vet HC, Koes BW, Vondeling H, Bouter LM: Cost effectiveness of physiotherapy, manual therapy, and general practitioner care for neck pain: economic evaluation alongside a randomised controlled trial. BMJ 2003, 326(7395):911.
59.
Lewis M, James M, Stokes E, Hill J, Sim J, Hay E, Dziedzic K. An economic evaluation of three physiotherapy treatments for non-specific neck disorders alongside a randomized trial. Rheumatology (Oxford). 2007;46(11):1701–8.CrossRef
60.
Bosmans JE, Pool JJ, de Vet HC, van Tulder MW, Ostelo RW. Is behavioral graded activity cost-effective in comparison with manual therapy for patients with subacute neck pain? An economic evaluation alongside a randomized clinical trial. Spine. 2011;36(18):E1179–86.CrossRefPubMed
61.
Rivero-Arias O, Gray A, Frost H, Lamb SE, Stewart-Brown S. Cost-utility analysis of physiotherapy treatment compared with physiotherapy advice in low back pain. Spine (Phila Pa 1976). 2006;31(12):1381–7.CrossRef
62.
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;16(11):1292–304.CrossRefPubMedPubMedCentral
63.
Fritz JM, Kim M, Magel JS, Asche CV. Cost-effectiveness of primary care management with or without early physical therapy for acute low back pain: economic evaluation of a randomized clinical trial. Spine. 2017;42(5):285–90.CrossRefPubMed
64.
UK BEAM Trial Team. United Kingdom back pain exercise and manipulation (UK BEAM) randomised trial: cost effectiveness of physical treatments for back pain in primary care. BMJ. 2004;329(7479):1381.
65.
Hurwitz EL. Epidemiology: spinal manipulation utilization. J Electromyogr Kinesiol. 2012;22(5):648–54.CrossRefPubMed
66.
Papanicolas I, Woskie LR, Jha AK. Health care spending in the United States and other high-income countries. JAMA. 2018;319(10):1024–39.CrossRefPubMed
67.
Anderson GF, Reinhardt UE, Hussey PS, Petrosyan V. It’s the prices, stupid: why the United States is so different from other countries. Health affairs (Project Hope). 2003;22(3):89–105.CrossRef
Metadata
Title
Cost-effectiveness of spinal manipulation, exercise, and self-management for spinal pain using an individual participant data meta-analysis approach: a study protocol
Authors
Brent Leininger
Gert Bronfort
Roni Evans
James Hodges
Karen Kuntz
John A. Nyman
Publication date
01-12-2018
Publisher
BioMed Central
Published in
Chiropractic & Manual Therapies / Issue 1/2018
Electronic ISSN: 2045-709X
DOI
https://doi.org/10.1186/s12998-018-0216-9

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