Aims: To investigate the benefits and harms of analgesic and adjuvant pain drugs typically administered in primary care settings on pain and disability in patients with spine-related leg pain?
Search: This systematic review will include randomised controlled trials that compare the effects of pharmacological interventions typically administered in primary care settings for people with sciatica with placebo control groups. We will search for potential studies in the EMBASE, MEDLINE, Cochrane Library, and International Pharmaceutical Abstracts electronic databases. We will search for ongoing and unpublished studies using the clinicaltrials.gov, Australian New Zealand Clinical Trials Registry (ANZCTR), EU Clinical Trials Register, and WHO International Clinical Trials Registry electronic databases. Two authors will independently screen the records for eligibility, and we will independently extract data in duplicate.
Data Synthesis: Trials that we consider to be clinically homogenous will be grouped according to duration of symptoms (i.e., non-chronic [<12 weeks] and chronic [≥12 weeks]), class of drug, outcomes (e.g., pain, disability), and outcome assessment timepoints (e.g., immediate, short-term, intermediate-term, long-term). Pooled effects will be calculated with a random effects model. Where trials are not sufficiently homogenous, we will describe outcome data of individual trials. For dichotomous outcomes, we will calculate risk ratios (RRs) and 95% CIs to describe the treatment effects. Risk of bias assessment will be conducted by two reviewers independently using the Cochrane Risk of Bias 2 (RoB-2) tool. To evaluate the overall certainty of evidence and strength of recommendation we will use the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) framework.
Subgroup analysis: Where there are at least three trials in a meta-analysis we will conduct a subgroup analysis based on: risk of bias (ie. high versus low risk of bias), clinical setting (ie. Emergency department versus non-emergency department, and diagnostic criteria (ie. Required imaging confirmation of herniated disc (radiculopathy) or spinal stenosis versus no imaging confirmation required).