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ENROLLING BY INVITATION

NCT07058376

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

Sponsor: Jaseng Medical Foundation

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

19 Years - 69 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2025-10-31

Completion Date

2026-12-31

Last Updated

2025-11-19

Healthy Volunteers

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.

Inclusion Criteria: * Individuals experiencing low back pain for more than 3 months. * Low back pain Numeric Rating Scale (NRS) score of 5 or higher. * Aged 19 years or older and younger than 70 years. * Individuals who voluntarily agree to participate in the clinical study and provide written informed consent. Exclusion Criteria: * Diagnosed with serious underlying conditions that may cause low back or radiating leg pain (e.g., spinal metastases, acute fractures, or vertebral dislocations). * Presence of progressive neurological deficits or severe neurological symptoms. * Pain primarily caused by non-spinal soft tissue conditions (e.g., tumors, fibromyalgia, rheumatoid arthritis, gout). * Presence of other chronic diseases that may interfere with the treatment outcomes or their interpretation (e.g., stroke, myocardial infarction, kidney disease, diabetic neuropathy, dementia, epilepsy). * Currently taking steroids, immunosuppressants, psychiatric medications, or other drugs that may affect study outcomes. * Contraindications to acupuncture treatment or conditions making acupuncture unsafe: bleeding disorders, current anticoagulant therapy, or severe diabetes with high risk of infection. * Contraindications to herbal medicine or conditions making its use unsafe: disorders or post-surgical conditions affecting drug absorption, severe hepatic or renal disease (AST, ALT, γ-GTP, or serum creatinine more than twice the upper normal limit at screening). * Use of pain-altering medications such as Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or receipt of acupuncture treatment within 1 week prior to screening. * Pregnant or breastfeeding women, or those planning pregnancy. * Patients who underwent lumbar spine surgery within the last 3 months. * Participation in another clinical trial within 1 month prior to screening, or plans to participate in another clinical trial during this study or within 6 months of screening. * Difficulty in providing written informed consent. * Any other condition judged by the investigator to make participation in the study inappropriate.

Locations (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea