Clinical Research of Effectiveness and Safety of Herbal Medicine Strategy for Chronic Low Back Pain : A Prospective, Multicenter, Pragmatic Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Low Back Pain Numeric Rating Scale (NRS)
研究概览
简要总结
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.
详细描述
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.
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Herbal Medicine Strategy (Procedure)
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.
干预措施: Standard Korean Medicine Treatment (Procedure)
结局指标
主要结局
Low Back Pain Numeric Rating Scale (NRS)
时间窗: 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)
时间窗: 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.
次要结局
- 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)
- EQ-5D-5L (EuroQol-5 Dimension, 5-Level)(Baseline(Week 0), Week 3, 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)
- Health-related Quality of Life Instrument with 8 Items (HINT-8)(Baseline(Week 0), Week 3, Week 7, Week 12, Week 19, Week 26)
- Patient Health Questionnaire-15 (PHQ-15)(Baseline(Week 0), Week 7, Week 12, Week 19, Week 26)
- Credibility and Expectancy(Screening Visit)
- Economic evaluation question(Baseline(Week 0), Week 3, Week 7, Week 12, Week 19, Week 26)
- Drug Consumption(Baseline(Week 0), Week 3, Week 5, Week 7, Week 12, Week 19, Week 26)