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

NCT ID: NCT07058376

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-31
• Study Completion Date: 2026-12-31

Brief 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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Herbal Medicine Strategy Group

Participants in this group will receive individualized herbal medicine prescriptions tailored to their clinical condition (symptoms, imaging, and response to treatment). Prescriptions, including type, dosage, and frequency, are determined by Korean medicine doctors based on clinical judgment. The herbal medicine will be taken orally for a total of 30 days, prescribed every 10 days over three clinic visits. All prescription details will be recorded in the CRF.

Group Type: EXPERIMENTAL

Herbal Medicine Strategy

Intervention Type: PROCEDURE

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.

Standard Korean Medicine Treatment Group

Participants in this group will receive standard Korean medicine treatments for chronic low back pain, including acupuncture, electroacupuncture, cupping, infrared therapy, moxibustion, and physical therapy. Treatments are provided twice weekly for 5 weeks (maximum 10 sessions), with slight adjustments allowed depending on symptom severity. Treatment protocols are based on clinician judgment, and all interventions and points used are recorded.

Group Type: ACTIVE_COMPARATOR

Standard Korean Medicine Treatment

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jaseng Medical Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

In-Hyuk Ha, PhD

Role: PRINCIPAL_INVESTIGATOR

Jaseng Medical Foundation

Locations

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, South Korea

Countries

South Korea

Other Identifiers

JS-CT-2024-06

Identifier Type: -

Identifier Source: org_study_id