title: Gabapentinoids for chronic low back pain: a protocol for systematic review and meta-analysis of randomised controlled trials.
abstract: 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.
  
  
  
  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).
  
  
  
  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.
  
  
  
  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.
  
  
  
  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.
  
  
  
  CRD42016034040.
authors.affiliation: Department of Anesthesiology, McMaster University, Michael DeGroote School of Medicine, Hamilton, Ontario, Canada.
authors.forename: Harsha
authors.initials: H
authors.lastname: Shanthanna
authors.affiliation: Department of Anesthesiology and Biomedical Sciences, Queen's University, Kingston, Ontario, Canada.
authors.forename: Ian
authors.initials: I
authors.lastname: Gilron
authors.affiliation: Department of Anesthesiology, McMaster University, Michael DeGroote School of Medicine, Hamilton, Ontario, Canada.|Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Lehana
authors.initials: L
authors.lastname: Thabane
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.|Department of Medicine, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Devereaux
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada.|Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Mohit
authors.initials: M
authors.lastname: Bhandari
authors.affiliation: Department of Anesthesiology, McMaster University, Michael DeGroote School of Medicine, Hamilton, Ontario, Canada.
authors.forename: Rizq
authors.initials: R
authors.lastname: AlAmri
authors.affiliation: Department of Anesthesiology, McMaster University, Michael DeGroote School of Medicine, Hamilton, Ontario, Canada.
authors.forename: Manikandan
authors.initials: M
authors.lastname: Rajarathinam
authors.affiliation: Department of Anesthesiology, McMaster University, Michael DeGroote School of Medicine, Hamilton, Ontario, Canada.|Department of Neuroanesthesia, National Institute of Mental Health and Neurosciences, Bangalore, India.
authors.forename: Sriganesh
authors.initials: S
authors.lastname: Kamath
mesh_terms: D000588:Amines / Q000627:therapeutic use*; D059350:Chronic Pain / Q000188:drug therapy*; D003509:Cyclohexanecarboxylic Acids / Q000627:therapeutic use*; D000077206:Gabapentin; D006801:Humans; D017116:Low Back Pain / Q000188:drug therapy*; D009437:Neuralgia / Q000188:drug therapy*; D059408:Pain Management; D010147:Pain Measurement; D000069583:Pregabalin / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D000078202:Systematic Reviews as Topic; D005680:gamma-Aminobutyric Acid / Q000627:therapeutic use*; D015201:Meta-Analysis as Topic
chemical_list: D000588:Amines; D003509:Cyclohexanecarboxylic Acids; D000069583:Pregabalin; D005680:gamma-Aminobutyric Acid; D000077206:Gabapentin