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Clinical Trials in South Korea / NCT07058376
Enrolling by invitation Not applicable

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

NCT07058376 · tracked via the Priya Life Science South Korea tracker
Sponsor
Jaseng Medical Foundation
Phase
Not applicable
Started
2025-10-31
Last updated
2025-11-19

Condition(s) studied

Chronic Low-back Pain (cLBP)

Investigational drug(s) / intervention(s)

Herbal Medicine StrategyStandard Korean Medicine Treatment

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.

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.

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.

Eligibility

Sex
ALL
Min age
19 Years
Max age
69 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Low Back Pain Numeric Rating Scale (NRS) — Baseline(Week 0), Week 3, Week 5, Week 7, Week 12, Week 19, Week 26
    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).
  • Oswestry Disability Index (ODI) — Baseline(Week 0), Week 3, Week 5, Week 7, Week 12, Week 19, Week 26
    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.

Trial sites (1)

FacilityCityRegionStatus
Jaseng Hospital of Korean Medicine Seoul Gangnam-Gu

More Jaseng Medical Foundation trials in South Korea

Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain Starting soon
Clinical Research on the Comparative Effectiveness and Safety of JHG002 Therapy for Chronic Low Back Pain: A Multicenter Randomized Controlled Trial Recruiting
The Efficacy and Safety of Herbal Medicine Treatment for Obese Patients With Spinal and Joint Pain Enrolling by invitation
Non-pharmacological Treatment vs Pharmacological Treatment for Non-acute Lumbar Disc Herniation Recruiting
The Effectiveness and Safety of Pharmacopuncture on Inpatients With Acute Knee Pain Caused by Traffic Accidents Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07058376 on ClinicalTrials.gov ↗ ← All trials in South Korea