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

NCT07058376 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2025-11-19

No results posted yet for this study

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.

Conditions

  • Chronic Low-back Pain (cLBP)

Interventions

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.

Sponsors & Collaborators

  • Jaseng Medical Foundation

    lead OTHER

Principal Investigators

  • In-Hyuk Ha, PhD · Jaseng Medical Foundation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-31
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07058376 on ClinicalTrials.gov