NCT07058376

Clinical Research of Effectiveness and Safety of Herbal Medicine Strategy for Chronic Low Back Pain

Clinical Research of Effectiveness and Safety of Herbal Medicine Strategy for Chronic Low Back Pain : A Prospective, Multicenter, Pragmatic Randomized Clinical Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Jaseng Medical Foundation · Academic / Other
• Sex: All
• Age: 19 Years – 69 Years
• Healthy volunteers: Not accepted

Summary

This study is a pragmatic multicenter randomized controlled trial evaluating the effectiveness and safety of herbal medicine strategy for chronic low back pain, using standard Korean medicine treatment as the control.

Detailed description

0\. Background Chronic low back pain (CLBP) is a common musculoskeletal disorder often managed in Korean medicine. This study aims to evaluate the effectiveness and safety of herbal medicine strategies for CLBP within a real-world clinical setting. It was initiated as part of a national research project to generate evidence for insurance coverage of herbal prescriptions. 1. Patient Recruitment and Screening Phase A total of 150 patients with CLBP lasting more than 3 months will be recruited across seven Korean medicine hospitals. Patients will be randomly assigned (1:1) to either the herbal medicine strategy group or the standard Korean medicine treatment group. Randomization will be prospective and pragmatic, with no pre-specified protocol for individual treatments. 2. Treatment and Evaluation Phase Experimental Group (Herbal Medicine Strategy): Participants receive individualized herbal prescriptions based on clinical judgment. Medication is prescribed every 10 days for a total of 30 days. Control Group (Standard KM Treatment): Participants receive acupuncture, electroacupuncture, cupping, moxibustion, infrared therapy, and physical therapy twice weekly for 5 weeks, with slight variations allowed based on symptom severity. Treatment details and frequencies will be recorded in CRFs and assessed during and after the intervention. 3. Follow-Up Phase Participants will be followed up after the treatment period to assess outcomes. Evaluation includes pain intensity, affected areas, quality of life, and treatment adherence. 4. Monitoring Although the study is investigator-initiated, third-party monitoring will be conducted in accordance with HRPP and Korean GCP guidelines to ensure protocol compliance and data integrity.

Conditions

• Chronic Low-back Pain (cLBP)

Interventions

Type	Name	Description
PROCEDURE	Herbal Medicine Strategy	A pragmatic intervention involving tailored herbal prescriptions created by Korean medicine doctors. The specific composition, dose, and duration of herbal medicine vary per patient, and prescriptions are adjusted according to clinical response.
PROCEDURE	Standard Korean Medicine Treatment	This includes the application of Korean medical procedures widely used for chronic low back pain: Acupuncture: Insertion of needles at 10-20 selected acupoints for 10-15 minutes. Electroacupuncture: Electrical stimulation at 3 Hz to 4 acupoints for 10-15 minutes. Infrared Therapy: Application of infrared rays from 30 cm for 10-15 minutes. Cupping: Wet or dry cupping at 2-4 points on the lower back. Moxibustion: Applied to two points near the painful area at 43±1°C for 10-15 minutes. Physical Therapy (ICT or TENS): Applied for 10-15 minutes focusing on the quadratus lumborum. Treatment frequency is 2 times/week for 5 weeks, but may be adjusted to 1-3 times/week depending on symptoms. Total number of sessions is limited to 10.

Timeline

• Start date: 2025-10-31
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-07-10
• Last updated: 2025-11-19

Locations

1 site across 1 country: South Korea