Clinical Research on the Comparative Effectiveness and Safety of JHG002 Therapy for Chronic Low Back Pain: A Multicenter Randomized Controlled Trial

Обзор

A multicenter randomized controlled trial

Подробное описание

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.

Вмешательства

• Препарат Hominis placental pharmacopuncture
  JHG002 pharmacopuncture is a purified Hominis placenta extract formulated for injection at acupuncture points. In Korean medicine, Hominis placenta has traditionally been used to support vitality, relieve chronic pain, and enhance functional recovery.
• Устройство Tanscutaneous electrical nerve stimulation (TENS)
  Transcutaneous electrical nerve stimulation is a non-invasive physical therapy that delivers low-intensity electrical stimulation to the lumbar area to reduce pain and muscle tension.

Первичные конечные точки

• Change in low back pain intensity (NRS) [Срок оценки: Week 1, 2-5, 6, 9, 13, 25]

Вторичные конечные точки (12)

• Change in radiating leg pain intensity (NRS) [Срок оценки: Week 1, 2-5, 6, 9, 13, 25]
• Low back pain Visual Analogue Scale (VAS) [Срок оценки: Week 1, 2-5, 6, 9, 13, 25]
• Radiating leg pain Visual Analogue Scale (VAS) [Срок оценки: Week 1, 2-5, 6, 9, 13, 25]
• Oswestry Disability Index (ODI) [Срок оценки: Weeks 1, 6, 13, 25]
• 6-item Roland-Morris Disability Questionnaire (RMDQ-6) [Срок оценки: Weeks 1, 6, 13, 25]
• Patient Global Impression of Change (PGIC) [Срок оценки: Week 6, 13, 25]
• Health-related Quality of Life (EQ-5D-5L) [Срок оценки: Weeks 1, 6, 13, 25]
• HINT-8 (Health-related Quality of Life Instrument) [Срок оценки: Weeks 1, 6, 13, 25]
• Analgesic consumption [Срок оценки: Week 1, 2-5, 6, 9, 13, 25]
• Credibility and Expectancy Questionnaire [Срок оценки: Screening]
• Work Productivity and Activity Impairment Questionnaire (WPAI) [Срок оценки: Week 1, 2-5, 6, 9, 13, 25]
• Economic evaluation variables [Срок оценки: Week 2]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

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

Простое слепое

Основная цель

Лечение

Центры проведения

South Korea · 4 центра

• Kyung Hee University Korean Medicine Hospital at Gangdong — Seoul
• Jaseng Hospital of Korean Medicine — Seoul
• Bucheon Jaseng Hospital of Korean Medicine — Bucheon-si
• Dongguk University Bundang Oriental Hospital — Seongnam

Идентификаторы

NCT: NCT07304076 · JS-CT-2024-03

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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