Rational and design of an individual participant data meta-analysis of spinal manipulative therapy for chronic low back pain—a protocol

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Abstract

Background

Chronic low back pain (LBP) is the leading cause of pain and disability, resulting in a major socioeconomic impact. The Cochrane Review which examined the effect of spinal manipulative therapy (SMT) for chronic LBP concluded that SMT is moderately effective, but was based on conventional meta-analysis of aggregate data. The use of individual participant data (IPD) from trials allows for a more precise estimate of the treatment effect and has the potential to identify moderators and/or mediators. The aim is (1) to assess the overall treatment effect of SMT for primary and secondary outcomes in adults with chronic LBP, (2) to determine possible moderation of baseline characteristics on treatment effect, (3) to identify characteristics of intervention (e.g., manipulation/mobilization) that influence the treatment effect, and (4) to identify mediators of treatment effects.

Methods

All trials included in the Cochrane Review on SMT for chronic LBP will be included which were published after the year 2000, and the search will be updated. No restrictions will be placed on the type of comparison or size of the study. Primary outcomes are pain intensity and physical functioning. A dataset will be compiled consisting of individual trials and variables included according to a predefined coding scheme. Variables to be included are descriptive of characteristics of the study, treatment, comparison, participant characteristics, and outcomes at all follow-up periods. A one-stage approach with a mixed model technique based on the intention-to-treat principle will be used for the analysis. Subsequent analyses will focus on treatment effect moderators and mediators.

Discussion

We will analyze IPD for LBP trials in which SMT is one of the interventions. IPD meta-analysis has been shown to be more reliable and valid than aggregate data meta-analysis, although this difference might also be attributed to the number of studies that can be used or the amount of data that can be utilized. Therefore, this project may identify important gaps in our knowledge with respect to prognostic factors of treatment effects.

Systematic review registration:

PROSPERO CRD42015025714

Electronic supplementary material

The online version of this article (doi:10.1186/s13643-017-0413-y) contains supplementary material, which is available to authorized users.

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Most cited references 30

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A systematic review of psychological factors as predictors of chronicity/disability in prospective cohorts of low back pain.

Tamar Pincus, A Burton, Steve Vogel … (2002)

A systematic review of prospective cohort studies in low back pain. To evaluate the evidence implicating psychological factors in the development of chronicity in low back pain. The biopsychosocial model is gaining acceptance in low back pain, and has provided a basis for screening measurements, guidelines and interventions; however, to date, the unique contribution of psychological factors in the transition from an acute presentation to chronicity has not been rigorously assessed. A systematic literature search was followed by the application of three sets of criteria to each study: methodologic quality, quality of measurement of psychological factors, and quality of statistical analysis. Two reviewers blindly coded each study, followed by independent assessment by a statistician. Studies were divided into three environments: primary care settings, pain clinics, and workplace. Twenty-five publications (18 cohorts) included psychological factors at baseline. Six of these met acceptability criteria for methodology, psychological measurement, and statistical analysis. Increased risk of chronicity (persisting symptoms and/or disability) from psychological distress/depressive mood and, to a lesser extent, somatization emerged as the main findings. Acceptable evidence generally was not found for other psychological factors, although weak support emerged for the role of catastrophizing as a coping strategy. Psychological factors (notably distress, depressive mood, and somatization) are implicated in the transition to chronic low back pain. The development and testing of clinical interventions specifically targeting these factors is indicated. In view of the importance attributed to other psychological factors (particularly coping strategies and fear avoidance) there is a need to clarify their role in back-related disability through rigorous prospective studies.

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Get real in individual participant data (IPD) meta‐analysis: a review of the methodology

Thomas P A Debray, Karel G. M. Moons, Gert van Valkenhoef … (2015)

Individual participant data (IPD) meta‐analysis is an increasingly used approach for synthesizing and investigating treatment effect estimates. Over the past few years, numerous methods for conducting an IPD meta‐analysis (IPD‐MA) have been proposed, often making different assumptions and modeling choices while addressing a similar research question. We conducted a literature review to provide an overview of methods for performing an IPD‐MA using evidence from clinical trials or non‐randomized studies when investigating treatment efficacy. With this review, we aim to assist researchers in choosing the appropriate methods and provide recommendations on their implementation when planning and conducting an IPD‐MA. © 2015 The Authors. Research Synthesis Methods published by John Wiley & Sons, Ltd.

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The global burden of musculoskeletal conditions for 2010: an overview of methods.

Lidia Sanchez, Theo Vos, Emily Carnahan … (2014)

The objective of this paper is to provide an overview of methods used for estimating the burden from musculoskeletal (MSK) conditions in the Global Burden of Diseases 2010 study. It should be read in conjunction with the disease-specific MSK papers published in Annals of Rheumatic Diseases. Burden estimates (disability-adjusted life years (DALYs)) were made for five specific MSK conditions: hip and/or knee osteoarthritis (OA), low back pain (LBP), rheumatoid arthritis (RA), gout and neck pain, and an 'other MSK conditions' category. For each condition, the main disabling sequelae were identified and disability weights (DW) were derived based on short lay descriptions. Mortality (years of life lost (YLLs)) was estimated for RA and the rest category of 'other MSK', which includes a wide range of conditions such as systemic lupus erythematosus, other autoimmune diseases and osteomyelitis. A series of systematic reviews were conducted to determine the prevalence, incidence, remission, duration and mortality risk of each condition. A Bayesian meta-regression method was used to pool available data and to predict prevalence values for regions with no or scarce data. The DWs were applied to prevalence values for 1990, 2005 and 2010 to derive years lived with disability. These were added to YLLs to quantify overall burden (DALYs) for each condition. To estimate the burden of MSK disease arising from risk factors, population attributable fractions were determined for bone mineral density as a risk factor for fractures, the occupational risk of LBP and elevated body mass index as a risk factor for LBP and OA. Burden of Disease studies provide pivotal guidance for governments when determining health priority areas and allocating resources. Rigorous methods were used to derive the increasing global burden of MSK conditions.

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Author and article information

Contributors

A. de Zoete:

ORCID: http://orcid.org/0000-0002-1421-3862

a.de.zoete@vu.nl

M. R. de Boer: m.r.de.boer@vu.nl

M. W. van Tulder: maurits.van.tulder@vu.nl

S. M. Rubinstein: s.m.rubinstein@vu.nl

M. Underwood: M.Underwood@warwick.ac.uk

J. A. Hayden: JHayden@Dal.ca

J. Kalter: j.kalter@vumc.nl

R. Ostelo: r.ostelo@vu.nl

Journal

Journal ID (nlm-ta): Syst Rev

Journal ID (iso-abbrev): Syst Rev

Title: Systematic Reviews

Publisher: BioMed Central (London )

ISSN (Electronic): 2046-4053

Publication date (Electronic): 26 January 2017

Publication date PMC-release: 26 January 2017

Publication date Collection: 2017

Volume: 6

Electronic Location Identifier: 21

Affiliations

[1 ]ISNI 0000 0004 0435 165X, GRID grid.16872.3a, Department of Epidemiology and Biostatistics, EMGO+ Institute for Health and Care Research, , VU University Medical Center, ; Amsterdam, Netherlands

[2 ]ISNI 0000 0004 1754 9227, GRID grid.12380.38, Department of Health Science, Institute for Health and Care Research, Faculty of Earth & Life Science, , VU University, ; De Boelelaan 1085, 1081HV Amsterdam, The Netherlands

[3 ]ISNI 0000 0000 8809 1613, GRID grid.7372.1, Warwick Clinical Trials Unit, Warwick Medical School, , The University of Warwick, ; Coventry, CV4 7AL UK

[4 ]ISNI 0000 0004 1936 8200, GRID grid.55602.34, Department of Community Health & Epidemiology, , Dalhousie University, ; Halifax, Nova Scotia B3H 1V7 Canada

Author information

A. de Zoete http://orcid.org/0000-0002-1421-3862

Article

Publisher ID: 413

DOI: 10.1186/s13643-017-0413-y

PMC ID: 5267437

PubMed ID: 28122640

SO-VID: a9162f49-cb8d-4601-8d14-916e0e3b103b

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 23 May 2016

Date accepted : 9 January 2017

Funding

Funded by: European Chiropractic Union Research fund

Award ID: ECU RF Contract No A.14.03

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ScienceOpen disciplines: Public health

Keywords: low back pain,spinal manipulative therapy,individual participant data

Data availability:

ScienceOpen disciplines: Public health

Keywords: low back pain, spinal manipulative therapy, individual participant data

Rational and design of an individual participant data meta-analysis of spinal manipulative therapy for chronic low back pain—a protocol

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Most cited references 30

A systematic review of psychological factors as predictors of chronicity/disability in prospective cohorts of low back pain.

Get real in individual participant data (IPD) meta‐analysis: a review of the methodology

The global burden of musculoskeletal conditions for 2010: an overview of methods.

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