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

NCT07058376 | Enrolling By Invitation DMC

• 1 other identifier: JS-CT-2024-06
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain (cLBP)

Keywords

herbal medicine; chronic back pain

Outcome Measures

Primary Outcomes (2)

• Low Back Pain Numeric Rating Scale (NRS)

  The primary outcome measure will be the change in the NRS score between Baseline and Week 7, which corresponds to the first follow-up visit after the end of treatment. The intensity of low back pain over the past week will be assessed using the NRS. In this scale, patients select a number from 0 to 10 that best represents their current level of discomfort (0 indicates no pain, and 10 indicates the worst pain imaginable).

  Baseline(Week 0), Week 3, Week 5, Week 7, Week 12, Week 19, Week 26

• Oswestry Disability Index (ODI)

  The primary outcome measure will be the change in the ODI score between Baseline and Week 7, which corresponds to the first follow-up visit after the end of treatment. The functional status of participants will be evaluated using the ODI questionnaire, which was developed to assess the degree of disability caused by low back pain. The ODI consists of 10 items, each rated on a 6-point scale from 0 to 5. The total score is summed and then divided by the maximum possible score (50 points for 10 items) to calculate a percentage. A higher percentage indicates a greater level of disability. A validated Korean version of the ODI will be used in this study.

  Baseline(Week 0), Week 3, Week 5, Week 7, Week 12, Week 19, Week 26

Secondary Outcomes (10)

• Radiating Leg Pain Numeric Rating Scale (NRS)

  Baseline(Week 0), Week 3, Week 5, Week 7, Week 12, Week 19, Week 26

• Low Back Pain and Radiating Leg Pain Visual Analogue Scale (VAS)

  Baseline(Week 0), Week 7, Week 12, Week 19, Week 26

• Roland-Morris Disability Questionnaire-6 (RMDQ-6)

  Baseline(Week 0), Week 7, Week 12, Week 19, Week 26

• Patient Global Impression of Change (PGIC)

  Week 7

• EQ-5D-5L (EuroQol-5 Dimension, 5-Level)

  Baseline(Week 0), Week 3, Week 7, Week 12, Week 19, Week 26

Other Outcomes (1)

• Adverse Events

  Week 1, Week 2, Week 3, Week 4, Week 5, Week 7, Week 12, Week 19, Week 26

Study Arms (2)

Herbal Medicine Strategy Group

EXPERIMENTAL

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.

Procedure: Herbal Medicine Strategy

Standard Korean Medicine Treatment Group

ACTIVE COMPARATOR

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.

Procedure: Standard Korean Medicine Treatment

Interventions

Herbal Medicine Strategy 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.

Herbal Medicine Strategy Group

Standard Korean Medicine Treatment 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.

Standard Korean Medicine Treatment Group

Eligibility Criteria

• Age: 19 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

Study Officials

• In-Hyuk Ha, PhD

  Jaseng Medical Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: October 31, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)