Ginger Root Extract for Sciatic Pain Individuals

Summary

Neuropathic pain affects the quality of life of many Americans. Non-pharmacological strategies such as bioactive compounds in foods are being explored as therapeutics but can also serve as tools to better understand pain mechanisms. The previous study reported that ginger root extract supplementation palliated pain-spectrum behaviors in animals with neuropathic pain via the microbiota-gut-brain axis. The proposed study is primarily designed to use ginger supplementation for a better understanding of the role of microbiota-gut-brain interactions in sciatica states in a randomized, double-blinded, and placebo-controlled trial. Eighty participants with sciatica will be randomized to receive placebo (2000 mg starch daily) or ginger (2000 mg daily) for 8 weeks. This study will evaluate the effects of ginger supplementation on gut function measured as gut microbiota composition using 16S rRNA sequencing analysis, intestinal permeability based on plasma lipopolysaccharide binding protein and fecal zonulin using ELISA, and fecal metabolites using LC-MS/MS analysis (SA 1); on neuroinflammation in whole blood mRNA using nCounter® Neuroinflammation Panels analysis (SA 2); and on pain-associated outcomes and brain neuroplasticity by assessing functional (resting state-fMRI) and structural (Diffusion Tensor Imaging) connectivity (SA 3).

Timeline

Start

2025-07-01

Primary completion

2028-02-28

Completion

2028-02-28

Publications

• Background Shen CL, Watkins BA, Kahathuduwa C, Chyu MC, Zabet-Moghaddam M, Elmassry MM, Luk HY, Brismee JM, Knox A, Lee J, Zumwalt M, Wang R, Wager TD, Neugebauer V. Tai Chi Improves Brain Functional Connectivity and Plasma Lysophosphatidylcholines in Postmenopausal Women With Knee Osteoarthritis: An Exploratory Pilot Study. Front Med (Lausanne). 2022 Jan 3;8:775344. doi: 10.3389/fmed.2021.775344. eCollection 2021.
• Background Goncalves L, Dickenson AH. Asymmetric time-dependent activation of right central amygdala neurones in rats with peripheral neuropathy and pregabalin modulation. Eur J Neurosci. 2012 Nov;36(9):3204-13. doi: 10.1111/j.1460-9568.2012.08235.x. Epub 2012 Aug 3.
• Background Checchia GA, Letizia Mauro G, Morico G, Oriente A, Lisi C, Polimeni V, Lucia M, Ranieri M; Management of Peripheral Neuropathies Study Group. Observational multicentric study on chronic sciatic pain: clinical data from 44 Italian centers. Eur Rev Med Pharmacol Sci. 2017 Apr;21(7):1653-1664.
• Background Nation KM, De Felice M, Hernandez PI, Dodick DW, Neugebauer V, Navratilova E, Porreca F. Lateralized kappa opioid receptor signaling from the amygdala central nucleus promotes stress-induced functional pain. Pain. 2018 May;159(5):919-928. doi: 10.1097/j.pain.0000000000001167.
• Background U Jumbo S, C MacDermid J, E Kalu M, L Packham T, S Athwal G, J Faber K. Measurement Properties of the Brief Pain Inventory-Short Form (BPI-SF) and the Revised Short McGill Pain Questionnaire-Version-2 (SF-MPQ-2) in Pain-related Musculoskeletal Conditions: A Systematic Review Protocol. Arch Bone Jt Surg. 2020 Mar;8(2):131-141. doi: 10.22038/abjs.2020.36779.1973.
• Background Dworkin RH, Turk DC, Revicki DA, Harding G, Coyne KS, Peirce-Sandner S, Bhagwat D, Everton D, Burke LB, Cowan P, Farrar JT, Hertz S, Max MB, Rappaport BA, Melzack R. Development and initial validation of an expanded and revised version of the Short-form McGill Pain Questionnaire (SF-MPQ-2). Pain. 2009 Jul;144(1-2):35-42. doi: 10.1016/j.pain.2009.02.007. Epub 2009 Apr 7.
• Background Shen CL, Wang R, Ji G, Elmassry MM, Zabet-Moghaddam M, Vellers H, Hamood AN, Gong X, Mirzaei P, Sang S, Neugebauer V. Dietary supplementation of gingerols- and shogaols-enriched ginger root extract attenuate pain-associated behaviors while modulating gut microbiota and metabolites in rats with spinal nerve ligation. J Nutr Biochem. 2022 Feb;100:108904. doi: 10.1016/j.jnutbio.2021.108904. Epub 2021 Nov 6.
• Background Shen CL, Wang R, Yakhnitsa V, Santos JM, Watson C, Kiritoshi T, Ji G, Hamood AN, Neugebauer V. Gingerol-Enriched Ginger Supplementation Mitigates Neuropathic Pain via Mitigating Intestinal Permeability and Neuroinflammation: Gut-Brain Connection. Front Pharmacol. 2022 Jul 8;13:912609. doi: 10.3389/fphar.2022.912609. eCollection 2022.
• Shen CL, Elmassry MM, Kahathuduwa C, Lee J, Day MR, Edwards DS, Parmar H, Wager TD, Liu X, Baccus M, Hamood A, Neugebauer V. 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. Clin Nutr ESPEN. 2026 Jun;73:103117. doi: 10.1016/j.clnesp.2026.103117. Epub 2026 Mar 12.

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