JHG002 pharmacopuncture versus TENS for chronic low back pain

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

This trial will test whether JHG002 pharmacopuncture reduces pain more than standard physical therapy with TENS in adults with chronic low back pain lasting at least six months.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 19 Years to 70 Years
• Sex: All
• Sponsor: Jaseng Medical Foundation (Academic / other)
• Locations: 4 sites (Seoul, Gangdong-gu and 3 other locations)
• Trial ID: NCT07304076 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 19–69 with chronic low back pain of six months or longer and a screening pain score of NRS ≥ 5 who can attend twice-weekly treatment visits are ideal candidates.

Not a fit: Patients with serious spinal pathology (e.g., metastatic disease, acute vertebral fracture, severe progressive neurological deficits), pain from non-spinal systemic disorders (e.g., fibromyalgia, rheumatoid arthritis), or those outside the age range are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, JHG002 pharmacopuncture could offer greater pain relief and improved function as a non-surgical treatment option for people with chronic low back pain.

How similar studies have performed: Small single-center trials of pharmacopuncture and related acupuncture approaches have reported modest benefits for low back pain, but high-quality multicenter randomized evidence is still limited.

Eligibility criteria

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 this trial is running

Seoul, Gangdong-gu and 3 other locations

• 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

Conditions Chronic Low Back Pain; chronic low back pain; pharmacopuncture