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Anaesthesia
Protocol
Gabapentinoids for chronic low back pain: a protocol for systematic review and meta-analysis of randomised controlled trials
  1. Harsha Shanthanna1,
  2. Ian Gilron2,
  3. Lehana Thabane1,3,
  4. Philip J Devereaux3,4,
  5. Mohit Bhandari3,5,
  6. Rizq AlAmri1,
  7. Manikandan Rajarathinam1,
  8. Sriganesh Kamath1,6
  1. 1Department of Anesthesiology, McMaster University, Michael DeGroote School of Medicine, Hamilton, Ontario, Canada
  2. 2Department of Anesthesiology and Biomedical Sciences, Queen's University, Kingston, Ontario, Canada
  3. 3Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada
  4. 4Department of Medicine, McMaster University, Hamilton, Ontario, Canada
  5. 5Department of Surgery, McMaster University, Hamilton, Ontario, Canada
  6. 6Department of Neuroanesthesia, National Institute of Mental Health and Neurosciences, Bangalore, India
  1. Correspondence to Dr Harsha Shanthanna; harshamd{at}gmail.com

Abstract

Introduction Chronic low back pain (CLBP) is a common condition and causes significant pain, distress and disability across the world. It is multifactorial in aetiology and is challenging to manage. Although the underlying mechanism of pain is predominantly non-specific, many argue that there is a substantial neuropathic pain element. Neuropathic pain is more severe, with significant disability. Gabapentinoids, including gabapentin and pregabalin, have proven efficacy in some neuropathic pain conditions. Despite no clear evidence, a substantial population of patients with CLBP are treated with gabapentinoids.

Objectives We aim to assess whether the use of gabapentinoids is effective and safe in the treatment of predominant CLBP, by conducting a systematic review and meta-analysis of randomised control trials (RCTs).

Methodology We will search the databases of MEDLINE, EMBASE and Cochrane for RCTs published in English language and have used gabapentinoids for the treatment of CLBP. Study selection and data extraction will be performed independently by paired reviewers using structured electronic forms, piloted between pairs of reviewers. The review outcomes will be guided by Initiative on Methods, Measurement and Pain Assessment in Clinical Trials guidelines, with pain relief as the primary outcome. We propose to carry out meta-analysis if there are three or more studies in a particular outcome domain, using a random effects model. Pooled outcomes will be reported as weighted mean differences or standardised mean differences and risk ratios with their corresponding 95% CIs, for continuous outcomes and dichotomous outcomes, respectively. Rating of quality of evidence will be reported using GRADE summary of findings table.

Discussion The proposed systematic review will be able to provide valuable evidence to help decision-making in the use of gabapentinoids for the treatment of CLBP. This will help advance patient care and potentially highlight limitations in existing evidence to direct future research.

Ethics and dissemination Being a systematic review, this study would not necessitate ethical review and approval. We plan to report and publish our study findings in a high impact medical journal, with online access.

Trial registration number CRD42016034040.

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-013200

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    Footnotes

    • Contributors HS is the primary investigator; conceived the study concept; involved in conduct of the review and analysis and drafted the protocol manuscript. IG is a coinvestigator and content expert on neuropathic pain and analgesic clinical trials and involved in conduct and interpretation of study results. LT is a coinvestigator and involved in methodological supervision and conduct and interpretation of study results. PJD and MB are coinvestigators and involved in methodological supervision and conduct and interpretation of study results. MR, SK and RA are coinvestigators and involved in conduct of the review and manuscript preparation. All authors approve the publication of the protocol.

    • Competing interests None declared.

    • Provenance and peer review Not commissioned; externally peer reviewed.