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

NCT07304076 | Recruiting DMC

• 1 other identifier: JS-CT-2024-03
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 4

Brief Summary

A multicenter randomized controlled trial

Conditions

Chronic Low Back Pain (CLBP)

Keywords

chronic low back pain; pharmacopuncture

Outcome Measures

Primary Outcomes (1)

• Change in low back pain intensity (NRS)

  The primary outcome is the change in low back pain intensity between baseline and Week 6. Low back pain severity during the past week will be assessed using the Numeric Rating Scale (NRS), where patients rate their pain on an 11-point scale ranging from 0 (no pain) to 10 (the worst pain imaginable). Participants will be instructed to report their average low back pain intensity over the past 7 days.

  Week 1, 2-5, 6, 9, 13, 25

Secondary Outcomes (12)

• Change in radiating leg pain intensity (NRS)

  Week 1, 2-5, 6, 9, 13, 25

• Low back pain Visual Analogue Scale (VAS)

  Week 1, 2-5, 6, 9, 13, 25

• Radiating leg pain Visual Analogue Scale (VAS)

  Week 1, 2-5, 6, 9, 13, 25

• Oswestry Disability Index (ODI)

  Weeks 1, 6, 13, 25

• 6-item Roland-Morris Disability Questionnaire (RMDQ-6)

  Weeks 1, 6, 13, 25

Study Arms (2)

Hominis placental pharmacopuncture

EXPERIMENTAL

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.

Drug: Hominis placental pharmacopuncture

Physical Therapy Group

ACTIVE COMPARATOR

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.

Device: Tanscutaneous electrical nerve stimulation (TENS)

Interventions

Tanscutaneous electrical nerve stimulation (TENS) DEVICE

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.

Also known as: TENS, electrical nerve stimulation

Physical Therapy Group

Hominis placental pharmacopuncture DRUG

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.

Also known as: JHG002

Hominis placental pharmacopuncture

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (4)

Kyung Hee University Korean Medicine Hospital at Gangdong

Seoul, Gangdong-gu, 05278, South Korea

RECRUITING

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 06110, South Korea

RECRUITING

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, GGyeonggi-do, 14598, South Korea

RECRUITING

Dongguk University Bundang Oriental Hospital

Seongnam, GGyeonggi-do, 13601, South Korea

RECRUITING

MeSH Terms

Interventions

Transcutaneous Electric Nerve Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Central Study Contacts

In-Hyuk Ha, Dr

CONTACT

+82-1577-0007; hanihata@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2-arm parallel multicenter RCT

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 26, 2025
• Study Start: December 17, 2025
• Primary Completion (Estimated): November 28, 2029
• Study Completion (Estimated): November 28, 2029
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (4)