Gabapentinoids for chronic low back pain: a protocol for systematic review and meta-analysis of randomised controlled trials

Abstract

IntroductionChronic 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.ObjectivesWe 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).MethodologyWe 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.DiscussionThe 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 disseminationBeing 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 numberCRD42016034040.

Benefits and safety of gabapentinoids in chronic low back pain: A systematic review and meta-analysis of randomized controlled trials

“…This report has been prepared according to PRISMA guidelines [ 15 ], as suggested by the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network ( S1 PRISMA checklist ). Our detailed review protocol has been previously published [ 5 ].…”

“…The search was performed using a sensitive strategy by an experienced librarian for each specific database. We included terms referring to study population of low back pain, and terms referring to study interventions such as GB, PG, and anticonvulsants [ 5 ]. The strategy is provided as a supplementary file ( S1 Text ).…”

“…It is largely nonspecific in nature and in up to 85% of patients lacks a clear pathoanatomical diagnosis when present in isolation [ 1 – 4 ]. We have previously highlighted the etiological and treatment considerations for CLBP, along with the limitations within the existing evidence [ 5 ]. A large proportion of CLBP patients are treated with routine analgesic medications with unsatisfactory results leading to frequent exploration of second line options including gabapentinoids [ 6 , 7 ].…”

Assessment of the anti‐hyperalgesic efficacy of J‐2156, relative to clinically available analgesic/adjuvant agents in a rat model of mild to moderate chronic mechanical low back pain (LBP)

“…In our previous work in the more severe LBP‐10X rat model, there was a trend for gabapentin to alleviate mechanical hypersensitivity in the lumbar axial deep tissues but it did not reach statistical significance. In patients with cLBP, 10 there are conflicting data regarding gabapentin efficacy 5 . For example, in a placebo‐controlled study over a 6‐week treatment period, gabapentin was significantly better than placebo in terms of pain and mobility scores 19 .…”

“…For the adult population suffering from cLBP, approximately 11%‐12% of individuals are disabled by this condition 2 . Apart from experiencing significant pain and suffering, patients have impaired activities of daily living, and decreased quality of life 4,5 . As the world population ages, the prevalence of cLBP is predicted to increase substantially due to deterioration of the intervertebral discs in older people 6 .…”