A multicenter randomized controlled trial
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.
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.
Parallel
Hominis placental pharmacopuncture
DrugJHG002 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)
DeviceTranscutaneous 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.
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.
Change in radiating leg pain intensity (NRS)
Radiating leg pain severity will be evaluated using the same 0-10 Numeric Rating Scale (NRS), assessing the degree of pain or discomfort radiating from the lumbar region to the lower extremities. Participants will indicate the level of radiating pain they experienced during the past week, with higher scores representing greater severity.
Low back pain Visual Analogue Scale (VAS)
The 100-mm Visual Analogue Scale (VAS) will be used to assess the intensity of low back pain. Participants will mark a point on a horizontal line anchored by "no pain" at the left end and "the most severe pain imaginable" at the right end. The distance in millimeters from the left end will be recorded as the pain score. This measure will be collected repeatedly to monitor pain trajectory over time.
Radiating leg pain Visual Analogue Scale (VAS)
A VAS will also be used to evaluate radiating leg pain. Participants will indicate their perceived leg pain intensity on a 100-mm line in the same format used for the low back pain VAS. This measure provides a continuous index of radiating pain severity.
Oswestry Disability Index (ODI)
The Oswestry Disability Index is a validated questionnaire assessing disability related to chronic low back pain. It consists of 10 items covering domains such as pain intensity, lifting, sitting, standing, sleep, and social life. Each item is scored from 0 to 5, and the total score is converted into a percentage (0-100%), with higher scores indicating greater functional impairment.
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