A multicenter randomized controlled trial
This multicenter, randomized, parallel-group controlled trial aims to evaluate the effectiveness and safety of JHG002 pharmacopuncture in adults with chronic low back pain lasting more than 6 months. A total of 96 participants will be randomly assigned in a 1:1 ratio to receive either JHG002 pharmacopuncture or standard physical therapy with transcutaneous electrical nerve stimulation (TENS). Participants in the JHG002 group will receive 10 treatment sessions over 5 weeks (twice weekly), with 0.05-0.1 mL of JHG002 administered to 8-10 acupuncture points commonly used for lumbar pain. The control group will receive standardized TENS therapy twice weekly for 15 minutes per session during the same treatment period. Outcome assessments will be conducted at baseline and Weeks 1, 2-5, 9, 6, 13, and 25. The primary outcome is the change in low back pain intensity measured by the Numeric Rating Scale (NRS) at Week 6. Secondary outcomes include radiating leg pain NRS, visual analogue scale (VAS) scores, functional disability (Oswestry Disability Index; 6-item Roland-Morris Disability Questionnaire), quality of life (EQ-5D-5L; HINT-8), patient global impression of change (PGIC), credibility/expectancy, analgesic use, and economic outcomes such as direct/indirect medical costs and productivity loss. Safety will be assessed through adverse event monitoring, vital signs, laboratory tests, and concomitant medication review. Adverse events will be evaluated according to WHO-UMC causality and standard severity grading. The study will follow a 4-year timeline from IRB approval to final follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
96
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.
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.
Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, Gangdong-gu, South Korea
RECRUITINGJaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, South Korea
RECRUITINGBucheon Jaseng Hospital of Korean Medicine
Bucheon-si, GGyeonggi-do, South Korea
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.
Time frame: Week 1, 2-5, 6, 9, 13, 25
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.
Time frame: Week 1, 2-5, 6, 9, 13, 25
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.
Time frame: Week 1, 2-5, 6, 9, 13, 25
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.
Time frame: Week 1, 2-5, 6, 9, 13, 25
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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Dongguk University Bundang Oriental Hospital
Seongnam, GGyeonggi-do, South Korea
RECRUITINGTime frame: Weeks 1, 6, 13, 25
6-item Roland-Morris Disability Questionnaire (RMDQ-6)
The RMDQ-6 is a short form of the Roland-Morris Disability Questionnaire that evaluates functional limitations in daily activities due to low back pain. The questionnaire consists of 6 binary (yes/no) items, and the total score ranges from 0 to 6. Higher scores reflect more severe disability.
Time frame: Weeks 1, 6, 13, 25
Patient Global Impression of Change (PGIC)
PGIC is a single-item global assessment that measures the participant's overall perception of improvement or worsening after treatment. It uses a 7-point Likert scale, ranging from "very much improved" to "very much worse." This outcome captures the participant's subjective treatment benefit.
Time frame: Week 6, 13, 25
Health-related Quality of Life (EQ-5D-5L)
The EQ-5D-5L evaluates quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each item has five response levels (no problems to extreme problems). The questionnaire also includes a 0-100 visual analogue scale to assess the participant's self-rated health status. Higher index values and VAS scores indicate better quality of life.
Time frame: Weeks 1, 6, 13, 25
HINT-8 (Health-related Quality of Life Instrument)
HINT-8 is a Korean-developed quality-of-life measurement tool consisting of eight items assessing physical, social, and mental health. Each item uses a 4-level response scale, and lower scores indicate better health status. This instrument is widely used in Korean health-economic studies.
Time frame: Weeks 1, 6, 13, 25
Analgesic consumption
Participants will record all use of rescue analgesic medications throughout the study period. Data will include type, dose, frequency, and duration of use. Increased analgesic intake may indicate worsening symptoms or insufficient treatment response.
Time frame: Week 1, 2-5, 6, 9, 13, 25
Credibility and Expectancy Questionnaire
This scale evaluates the participant's belief in the credibility and potential effectiveness of the assigned treatment. It includes both cognitive credibility items and emotional expectancy items, scored on Likert scales. Higher scores indicate greater perceived treatment plausibility and expected benefit.
Time frame: Screening
Work Productivity and Activity Impairment Questionnaire (WPAI)
The WPAI assesses the impact of low back pain on work performance and daily activities. It includes four domains: absenteeism, presenteeism, overall work impairment, and activity limitations. Scores are expressed as percentages, with higher percentages reflecting greater impairment.
Time frame: Week 1, 2-5, 6, 9, 13, 25
Economic evaluation variables
Costs related to medical care, transportation, time burden, lost productivity, and indirect cost components will be collected to evaluate the cost-effectiveness of JHG002 compared with TENS. Data will be used for both cost-effectiveness and cost-utility analyses.
Time frame: Week 2