Clinical Research on the Comparative Effectiveness and Safety of JHG002 Therapy for Chronic Low Back Pain: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 4
- 主要终点
- Change in low back pain intensity (NRS)
研究概览
简要总结
A multicenter randomized controlled trial
详细描述
This multicenter, randomized, parallel-group controlled trial aims to evaluate the effectiveness and safety of JHG002 pharmacopuncture in adults with chronic low back pain lasting more than 6 months. A total of 96 participants will be randomly assigned in a 1:1 ratio to receive either JHG002 pharmacopuncture or standard physical therapy with transcutaneous electrical nerve stimulation (TENS).
Participants in the JHG002 group will receive 10 treatment sessions over 5 weeks (twice weekly), with 0.05-0.1 mL of JHG002 administered to 8-10 acupuncture points commonly used for lumbar pain. The control group will receive standardized TENS therapy twice weekly for 15 minutes per session during the same treatment period.
Outcome assessments will be conducted at baseline and Weeks 1, 2-5, 9, 6, 13, and 25. The primary outcome is the change in low back pain intensity measured by the Numeric Rating Scale (NRS) at Week 6. Secondary outcomes include radiating leg pain NRS, visual analogue scale (VAS) scores, functional disability (Oswestry Disability Index; 6-item Roland-Morris Disability Questionnaire), quality of life (EQ-5D-5L; HINT-8), patient global impression of change (PGIC), credibility/expectancy, analgesic use, and economic outcomes such as direct/indirect medical costs and productivity loss.
Safety will be assessed through adverse event monitoring, vital signs, laboratory tests, and concomitant medication review. Adverse events will be evaluated according to WHO-UMC causality and standard severity grading. The study will follow a 4-year timeline from IRB approval to final follow-up.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 to 69 years at the time of signing the informed consent.
- •Individuals who have experienced low back pain for ≥6 months, presenting with either continuous or intermittent symptoms.
- •Participants with a Numeric Rating Scale (NRS) score ≥ 5 for low back pain at screening.
- •Individuals who fully understand the clinical trial procedures and voluntarily agree to participate by providing written informed consent.
排除标准
- •Patients diagnosed with serious underlying conditions that may cause low back pain, such as spinal metastasis of malignancy, acute vertebral fracture, or spinal dislocation.
- •Patients with progressive neurological deficits or those presenting with severe neurological symptoms.
- •Patients whose pain originates from non-spinal soft tissue disorders, including tumors, fibromyalgia, rheumatoid arthritis, or gout.
- •Individuals with other chronic medical conditions that may interfere with treatment response or interpretation of study outcomes, such as stroke, myocardial infarction, chronic kidney disease, diabetic neuropathy, dementia, or epilepsy.
- •Individuals currently taking corticosteroids, immunosuppressants, psychiatric medications, or any other drugs that may influence study results.*
- •Patients for whom pharmacopuncture is inappropriate or unsafe, including those with bleeding disorders or those receiving anticoagulant therapy.
- •Individuals who have taken analgesic medications such as NSAIDs or received pharmacopuncture treatment within the past 1 week.
- •Women of childbearing potential who are unwilling to use medically acceptable contraception (e.g., surgical sterilization, intrauterine device, condom or diaphragm use, injectable or implantable contraceptives) throughout the study period.
- •Pregnant or breastfeeding women.
- •Individuals with a history of hypersensitivity or allergic reactions to Hominis placenta pharmacopuncture (JHG002).
- •Patients with uncontrolled diabetes mellitus (fasting blood glucose ≥ 180 mg/dL).
- •Individuals whose AST (GOT) or ALT (GPT) levels are ≥ 2 times the upper limit of the normal range at the study site.
- •Individuals whose serum creatinine levels are ≥ 2 times the upper limit of the normal range at the study site.
- •Patients suspected of having an underlying organic disease.
- •Patients with moderate systemic complications involving organs other than the heart, liver, or kidneys.
- •Patients with psychogenic disorders.
- •Individuals with an implanted cardiac pacemaker.
- •Patients with inflammation, infection, wounds, or other lesions at the planned pharmacopuncture sites that would prevent safe administration.
- •Patients within 3 months after lumbar spine surgery.
- •Individuals who have participated in another clinical trial within the past 1 month, or who plan to participate in another clinical trial-including follow-up periods-within 6 months from the screening date.
- •Any individual deemed unsuitable for participation in this study by the investigator.
研究组 & 干预措施
Hominis placental pharmacopuncture
Participants in the experimental group will receive JHG002 pharmacopuncture twice weekly for 5 weeks (total 10 sessions). JHG002 (0.05-0.1 mL per point) will be administered to 8-10 acupuncture points commonly used for chronic low back pain, including BL23, BL24, BL25, GV3, and GV4, with optional GB30 based on symptoms.
干预措施: Hominis placental pharmacopuncture (Drug)
Physical Therapy Group
Participants in the control group will receive standardized transcutaneous electrical nerve stimulation (TENS) therapy twice weekly for 5 weeks (total 10 sessions). Each session will last 15 minutes and will be administered using a unified protocol across all participating sites to target the lumbar region.
干预措施: Tanscutaneous electrical nerve stimulation (TENS) (Device)
结局指标
主要结局
Change in low back pain intensity (NRS)
时间窗: Week 1, 2-5, 6, 9, 13, 25
The primary outcome is the change in low back pain intensity between baseline and Week 6. Low back pain severity during the past week will be assessed using the Numeric Rating Scale (NRS), where patients rate their pain on an 11-point scale ranging from 0 (no pain) to 10 (the worst pain imaginable). Participants will be instructed to report their average low back pain intensity over the past 7 days.
次要结局
- Change in radiating leg pain intensity (NRS)(Week 1, 2-5, 6, 9, 13, 25)
- Low back pain Visual Analogue Scale (VAS)(Week 1, 2-5, 6, 9, 13, 25)
- 6-item Roland-Morris Disability Questionnaire (RMDQ-6)(Weeks 1, 6, 13, 25)
- Radiating leg pain Visual Analogue Scale (VAS)(Week 1, 2-5, 6, 9, 13, 25)
- Oswestry Disability Index (ODI)(Weeks 1, 6, 13, 25)
- Patient Global Impression of Change (PGIC)(Week 6, 13, 25)
- Health-related Quality of Life (EQ-5D-5L)(Weeks 1, 6, 13, 25)
- HINT-8 (Health-related Quality of Life Instrument)(Weeks 1, 6, 13, 25)
- Analgesic consumption(Week 1, 2-5, 6, 9, 13, 25)
- Credibility and Expectancy Questionnaire(Screening)
- Work Productivity and Activity Impairment Questionnaire (WPAI)(Week 1, 2-5, 6, 9, 13, 25)
- Economic evaluation variables(Week 2)