Clinical Research on the Comparative Effectiveness and Safety of JHG002 Therapy for Chronic Low Back Pain: A Multicenter Randomized Controlled Trial
NCT ID: NCT07304076
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
96 participants
INTERVENTIONAL
2025-12-17
2029-11-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
19 Years
70 Years
ALL
No
Sponsors
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Jaseng Medical Foundation
OTHER
Responsible Party
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Locations
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Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, Gangdong-gu, South Korea
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, South Korea
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, GGyeonggi-do, South Korea
Dongguk University Bundang Oriental Hospital
Seongnam, GGyeonggi-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Yeon-Chul Park, KMD
Role: primary
Yong-Jun Ahn, KMD
Role: primary
In-Hyuk Ha, KMD
Role: primary
Eunjung Kim, KMD
Role: primary
Other Identifiers
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JS-CT-2024-03
Identifier Type: -
Identifier Source: org_study_id