Influence of ginger root extract supplementation on the microbiota-gut-brain axis in individuals with sciatica: Study protocol for a double-blind, placebo-controlled randomized trial.

Neuropathic pain (NP) is caused by damage to the peripheral or central nervous system and is associated with adverse complex sensory and affective symptoms. There are few current treatment options for NP, and opioid analgesics have severe side effects which can lead to opioid abuse. Therefore, the development of innovative, effective, and safe alternatives is urgently needed. This study will assess the effects of ginger root extract's anti-inflammatory and anti-oxidant properties on individuals with sciatica via the microbiome-gut-brain axis. Eighty participants (18-85 years) with chronic sciatica, classified as lean (n = 40, BMI <25 kg/m2) or obese (n = 40, BMI ≥30 kg/m2), will be stratified by age, sex, and BMI to receive 2000 mg/day of ginger extract or placebo for eight weeks. Primary outcomes are pain-associated outcomes and brain neuroplasticity by assessing functional (resting state-fMRI) and structural (Diffusion Tensor Imaging) connectivity. Secondary outcomes include gut function (gut microbiota composition using 16S rRNA sequencing analysis, intestinal permeability assessing concentrations of plasma lipopolysaccharide binding protein and fecal zonulin, and fecal metabolites using LC-MS/MS analysis) and neuroinflammation: nCounter® Neuroinflammation Panel analysis. We will evaluate outcomes at baseline and end of study. We will employ intention-to-treat principle and per-protocol for data analysis. Hierarchical linear modeling is utilized to estimate ginger supplementation's effects while properly accounting for data dependency and identified covariates. This study was approved by the Bioethics Committee of the Texas Tech University Health Sciences Center, Lubbock, TX. Participants will sign an informed consent form before enrolling in the study. Our team will actively disseminate the results from this trial through academic conference presentations and peer-reviewed journals. We are now actively recruiting subjects for this study. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT06817018.