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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
Led by Jaseng Medical Foundation · Updated on 2026-02-25
96
Participants Needed
4
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are conducting a multicenter randomized controlled trial to compare the effectiveness and safety of JHG002 pharmacopuncture with standard physical therapy using transcutaneous electrical nerve stimulation (TENS) in adults experiencing chronic low back pain lasting more than six months. The study aims to assess pain intensity changes and other functional and quality of life outcomes over time. Ninety-six participants will be enrolled and randomly assigned to one of two treatment groups. Participants in the JHG002 group will receive ten treatment sessions over five weeks, administered twice weekly. Each session involves injecting 0.05-0.1 mL of JHG002, a purified Hominis placenta extract, into 8-10 acupuncture points commonly targeted for lumbar pain. The control group will undergo standardized TENS therapy twice weekly for 15 minutes per session across the same five-week period. Both treatments are delivered in a clinical setting following a unified protocol. Throughout the study, participants will undergo evaluations at baseline and multiple time points up to 25 weeks, including assessments of low back and radiating leg pain using the Numeric Rating Scale (NRS) and Visual Analogue Scale (VAS), disability questionnaires, quality of life measures, and tracking of analgesic use and economic impacts. Safety monitoring includes recording adverse events, vital signs, laboratory tests, and medication reviews. The entire study is planned to last four years from approval through final follow-up.
CONDITIONS
Brief Title
Clinical Research on the Comparative Effectiveness and Safety of JHG002 Therapy for Chronic Low Back Pain: A Multicenter Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 19 to 69 years at the time of signing informed consent
- Low back pain lasting 6 months or more, either continuous or intermittent
- Low back pain intensity score of 5 or higher on the Numeric Rating Scale at screening
- Ability to understand study procedures and provide voluntary written consent
You will not qualify if you...
- Serious underlying conditions causing low back pain such as spinal metastasis, acute vertebral fracture, or spinal dislocation
- Progressive or severe neurological symptoms
- Pain from non-spinal soft tissue disorders like tumors, fibromyalgia, rheumatoid arthritis, or gout
- Other chronic medical conditions affecting treatment or outcome interpretation such as stroke, myocardial infarction, chronic kidney disease, diabetic neuropathy, dementia, or epilepsy
- Current use of corticosteroids, immunosuppressants, psychiatric medications, or other drugs influencing study results
- Conditions making pharmacopuncture unsafe, including bleeding disorders or anticoagulant therapy
- Use of analgesics like NSAIDs or pharmacopuncture treatment within the past week
- Women of childbearing potential unwilling to use medically accepted contraception during the study
- Pregnant or breastfeeding women
- History of allergic reactions to Hominis placenta pharmacopuncture (JHG002)
- Uncontrolled diabetes (fasting glucose ≥180 mg/dL)
- Elevated liver enzymes (AST or ALT ≥2 times normal)
- Elevated serum creatinine (≥2 times normal)
- Suspected underlying organic disease
- Moderate systemic complications involving organs other than heart, liver, or kidneys
- Psychogenic disorders
- Implanted cardiac pacemaker
- Inflammation, infection, wounds, or other lesions at planned injection sites
- Lumbar spine surgery within past 3 months
- Participation in another clinical trial within past month or planned participation within 6 months
- Any other condition deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 weeks
Participants receive either JHG002 pharmacopuncture or standardized transcutaneous electrical nerve stimulation (TENS) therapy for chronic low back pain.
Twice weekly visits for a total of 10 treatment sessions
Duration - Up to 20 weeks after treatment
Participants are assessed for pain intensity, functional disability, quality of life, and safety after treatment completion.
Visits at Weeks 6, 9, 13, and 25 for outcome assessments
Trial Site Locations
Total: 4 locations
1
Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, Gangdong-gu, South Korea, 05278
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2
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, South Korea, 06110
Actively Recruiting
3
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, GGyeonggi-do, South Korea, 14598
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4
Dongguk University Bundang Oriental Hospital
Seongnam, GGyeonggi-do, South Korea, 13601
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Research Team
I
In-Hyuk Ha, Dr
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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