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Open Access Highly Accessed Protocol

Exercise therapy for chronic low back pain: protocol for an individual participant data meta-analysis

Jill A Hayden12*, Jennifer L Cartwright12, Richard D Riley3, Maurits W vanTulder4 and the Chronic Low Back Pain IPD Meta-Analysis Group

Author Affiliations

1 Department of Community Health & Epidemiology, Dalhousie University, Halifax, Nova Scotia, B3H 1V7, Canada

2 Nova Scotia Cochrane Resource Centre, Halifax, Nova Scotia, B3H 1V7, Canada

3 School of Health and Population Sciences, University of Birmingham, Birmingham, B15 2TT, UK

4 EMGO and Institute for Health and Care Research, VU University, Van der Boechorststraat 7, 1081 BT, Amsterdam, the Netherlands

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Systematic Reviews 2012, 1:64  doi:10.1186/2046-4053-1-64

Published: 21 December 2012

Abstract

Background

Low back pain (LBP) is one of the leading causes of disability and has a major socioeconomic impact. Despite a large amount of research in the field, there remains uncertainty about the best treatment approach for chronic LBP, and identification of relevant patient subgroups is an important goal. Exercise therapy is a commonly used strategy to treat chronic low back pain and is one of several interventions that evidence suggests is moderately effective.

In parallel with an update of the 2005 Cochrane review, we will undertake an individual participant data (IPD) meta-analysis, which will allow us to standardize analyses across studies and directly derive results, and to examine differential treatment effects across individuals to estimate how patients’ characteristics modify treatment benefit.

Methods/design

We will use standard systematic review methods advocated by the Cochrane Collaboration to identify relevant trials. We will include trials evaluating exercise therapy compared to any or no other interventions in adult non-specific chronic LBP. Our primary outcomes of interest include pain, functional status, and return-to-work/absenteeism. We will assess potential risk of bias for each study meeting selection criteria, using criteria and methods recommended by the Cochrane BRG.

The original individual participant data will be requested from the authors of selected trials having moderate to low risk of bias. We will test original data and compile a master dataset with information about each trial mapped on a pre-specified framework, including reported characteristics of the study sample, exercise therapy characteristics, individual patient characteristics at baseline and all follow-up periods, subgroup and treatment effect modifiers investigated. Our analyses will include descriptive, study-level meta-analysis and meta-regression analyses of the overall treatment effect, and individual-level IPD meta-analyses of treatment effect modification. IPD meta-analyses will be conducted using a one-step approach where the IPD from all studies are modeled simultaneously while accounting for the clustering of participants with studies.

Discussion

We will analyze IPD across a large number of LBP trials. The resulting larger sample size and consistent presentation of data will allow additional analyses to explore patient-level heterogeneity in treatment outcomes and prognosis of chronic LBP.

Keywords:
Low back pain; Exercise therapy; Meta-analysis; Systematic review