Comparative effectiveness and safety of herbal medicine therapy for low back pain and radiculopathy caused by lumbar intervertebral disc herniation: a study protocol for a pragmatic randomized controlled trial.

This study investigates whether herbal medicine from traditional Korean medicine can effectively treat low back pain and leg pain (radiculopathy) caused by herniated discs in the lower spine. Back pain from disc herniation is a common problem worldwide that significantly affects quality of life and creates substantial healthcare costs. In Korea, many patients seek traditional medicine treatments for these conditions, but there hasn't been enough rigorous scientific evidence showing how well these therapies work, especially for older adults who may face higher surgical risks.

Researchers are conducting a pragmatic randomized controlled trial with 74 adult participants who have confirmed disc herniation on MRI or CT scans and moderate radiating pain. Half the participants will receive herbal medicine therapy combined with other traditional Korean medicine treatments, while the other half will receive only the non-herbal traditional treatments. The study will track pain levels, disability, quality of life, and treatment costs over 26 weeks, while carefully monitoring for any side effects.

This research is still in the protocol stage, meaning the study is planned but results aren't yet available. Once completed, it aims to provide solid evidence about whether herbal medicine therapy is effective, safe, and cost-effective for treating herniated discs. The findings could help develop better treatment guidelines and give patients more evidence-based options for managing this painful condition, particularly for those seeking alternatives to surgery or looking to complement conventional treatments. If you're considering acupuncture or traditional medicine for back pain, seek care from a licensed practitioner certified in traditional Korean or Chinese medicine.

This pragmatic randomized controlled trial protocol evaluates herbal medicine therapy effectiveness for lumbar disc herniation with radiculopathy. The two-arm parallel study will enroll 74 adults (≥19 years) with imaging-confirmed disc pathology and NRS radiating pain scores of 3-6. Participants will be randomized to either herbal medicine strategy combined with traditional Korean medicine (TKM) or usual TKM care excluding herbal medicine. Primary outcomes are NRS radiating pain and Oswestry Disability Index changes at week 7, with secondary measures including pain, disability, quality of life, and economic evaluations through 26 weeks. Analysis will utilize intention-to-treat and per-protocol populations with linear mixed models for efficacy and chi-squared/Fisher's exact tests for safety data. Non-inferiority testing will follow if superiority is not demonstrated. This study addresses the evidence gap for conservative TKM management in disc herniation, particularly relevant for older patients with elevated surgical risks, and aims to inform evidence-based clinical guidelines.