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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.
• Процедура 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. Physic

Первичные конечные точки

• Low Back Pain Numeric Rating Scale (NRS) [Срок оценки: Baseline(Week 0), Week 3, Week 5, Week 7, Week 12, Week 19, Week 26]
• Oswestry Disability Index (ODI) [Срок оценки: Baseline(Week 0), Week 3, Week 5, Week 7, Week 12, Week 19, Week 26]

Вторичные конечные точки (10)

• Radiating Leg Pain Numeric Rating Scale (NRS) [Срок оценки: 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) [Срок оценки: Baseline(Week 0), Week 7, Week 12, Week 19, Week 26]
• Roland-Morris Disability Questionnaire-6 (RMDQ-6) [Срок оценки: Baseline(Week 0), Week 7, Week 12, Week 19, Week 26]
• Patient Global Impression of Change (PGIC) [Срок оценки: Week 7]
• EQ-5D-5L (EuroQol-5 Dimension, 5-Level) [Срок оценки: Baseline(Week 0), Week 3, Week 7, Week 12, Week 19, Week 26]
• Health-related Quality of Life Instrument with 8 Items (HINT-8) [Срок оценки: Baseline(Week 0), Week 3, Week 7, Week 12, Week 19, Week 26]
• Patient Health Questionnaire-15 (PHQ-15) [Срок оценки: Baseline(Week 0), Week 7, Week 12, Week 19, Week 26]
• Credibility and Expectancy [Срок оценки: Screening Visit]
• Economic evaluation question [Срок оценки: Baseline(Week 0), Week 3, Week 7, Week 12, Week 19, Week 26]
• Drug Consumption [Срок оценки: Baseline(Week 0), Week 3, Week 5, Week 7, Week 12, Week 19, Week 26]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• Jaseng Hospital of Korean Medicine — Seoul

Идентификаторы

NCT: NCT07058376 · JS-CT-2024-06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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