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

RecruitingNAAges 19 Years - 70 YearsAllJaseng Medical Foundation
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In plain words

What the trial is, and whether it could suit you

A multicenter randomized controlled trial

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adults aged 19 to 69 years at the time of signing the informed consent. * Individuals who have experienced low back pain for โ‰ฅ6 months, presenting with either continuous or intermittent symptoms. * Participants with a Numeric Rating Scale (NRS) score โ‰ฅ 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. Exclusion Criteria: * 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 โ‰ฅ 180 mg/dL). * Individuals whose AST (GOT) or ALT (GPT) levels are โ‰ฅ 2 times the upper limit of the normal range at the study site. * Individuals whose serum creatinine levels are โ‰ฅ 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.
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What it tests

  • Hominis placental pharmacopuncture
  • Tanscutaneous electrical nerve stimulation (TENS)
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Where

4 sites
Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, South Korea
Jaseng Hospital of Korean Medicine
Seoul, South Korea
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, South Korea
Dongguk University Bundang Oriental Hospital
Seongnam, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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