JHG002 pharmacopuncture versus TENS for chronic low back pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, randomized, parallel-group trial enrolling 96 adults with chronic low back pain for at least six months, randomized 1:1 to JHG002 pharmacopuncture or standardized TENS-based physical therapy. The JHG002 arm receives 10 pharmacopuncture sessions over 5 weeks (0.05–0.1 mL injected at 8–10 lumbar acupuncture points), while the control arm receives twice-weekly 15-minute TENS sessions for the same period. The primary outcome is change in low back pain intensity on the Numeric Rating Scale at Week 6, with additional assessments of leg pain, disability, quality of life, global impression of change, analgesic use, and economic outcomes through Week 25. Safety monitoring includes adverse event reporting, vital signs, laboratory tests, and concomitant medication review.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

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 ≥ 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.

Where it's running

• Kyung Hee University Korean Medicine Hospital at Gangdong
  Seoul, Gangdong-gu, South Korea Recruiting
• Jaseng Hospital of Korean Medicine
  Seoul, Gangnam-Gu, South Korea Recruiting
• Bucheon Jaseng Hospital of Korean Medicine
  Bucheon-si, GGyeonggi-do, South Korea Recruiting
• Dongguk University Bundang Oriental Hospital
  Seongnam, GGyeonggi-do, South Korea Recruiting

Study contacts

• Study coordinator: In-Hyuk Ha, Dr
• Email: hanihata@gmail.com
• Phone: +82-1577-0007

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.