Chronic Low Back Pain (CLBP)NCT07304076
Clinical Research on the Comparative Effectiveness and Safety of JHG002 Therapy for Chronic Low Back Pain: A Multicenter Randomized Controlled Trial
A study testing Hominis placental pharmacopuncture and Tanscutaneous electrical nerve stimulation (TENS) in people with Chronic Low Back Pain (CLBP), run by Jaseng Medical Foundation at 4 sites in South Korea.
Trial summary
A multicenter randomized controlled trial Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Chronic Low Back Pain (CLBP)
- What is being tested?
- Hominis placental pharmacopuncture and Tanscutaneous electrical nerve stimulation (TENS)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 17 Dec 2025to 28 Nov 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites, 4 recruiting
- Recruiting
Bucheon Jaseng Hospital of Korean Medicine
Bucheon-si, GGyeonggi-do, 14598
In-Hyuk Ha, KMD, +82-1577-0007, hanihata@gmail.com
- Recruiting
Dongguk University Bundang Oriental Hospital
Seongnam, GGyeonggi-do, 13601
Eunjung Kim, KMD, +82-10-5948-1075, hanijung@naver.com
- Recruiting
Kyung Hee University Korean Medicine Hospital at Gangdong
Seoul, Gangdong-gu, 05278
Yeon-Chul Park, KMD, +82-10-3395-1075, icarus08@hanmail.net
- Recruiting
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 06110
Yong-Jun Ahn, KMD, +82-1577-0007, ahnyj322@gmail.com
About this study
A multicenter randomized controlled trial
Read the detailed description
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.
- Conditions
- Chronic Low Back Pain (CLBP)
- Being tested
- Hominis placental pharmacopuncture, Tanscutaneous electrical nerve stimulation (TENS)
- Keywords
- chronic low back pain, pharmacopuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hominis placental pharmacopunctureDrug
Also called JHG002
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.
Tanscutaneous electrical nerve stimulation (TENS)Device
Also called TENS, electrical nerve stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Tanscutaneous electrical nerve stimulation (TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 1, 2-5, 6, 9, 13, 25
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start17 Dec 2025
- Primary completion28 Nov 2029 (estimated)
- Study completion28 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back Pain (CLBP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-arm parallel multicenter RCT
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304076
- Sponsor's protocol ID
- JS-CT-2024-03
- Status last verified
- Feb 2026
- First submitted
- 11 Dec 2025
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research on the Comparative Effectiveness and Safety of JHG002 Therapy for Chronic Low Back Pain: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07304076
- Acronym / sponsor ID
- JS-CT-2024-03
- Conditions
- Chronic Low Back Pain (CLBP)
- Keywords
- chronic low back pain, pharmacopuncture
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 17 Dec 2025 (actual)
- Primary completion
- 28 Nov 2029 (estimated)
- Study completion
- 28 Nov 2029 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A multicenter randomized controlled trial
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2-arm parallel multicenter RCT
| Arm | Type | Receives |
|---|---|---|
| Hominis placental pharmacopuncture | Experimental | Drug: Hominis placental pharmacopunctureParticipants 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. |
| Physical Therapy Group | Active comparator | Device: Tanscutaneous electrical nerve stimulation (TENS)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. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.*
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hominis placental pharmacopunctureAlso: JHG002JHG002 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. | Drug | Hominis placental pharmacopuncture |
| Tanscutaneous electrical nerve stimulation (TENS)Also: TENS, electrical nerve stimulationTranscutaneous 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. | Device | Physical Therapy Group |
Primary outcome
Change in low back pain intensity (NRS)
Time frame: Week 1, 2-5, 6, 9, 13, 25
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.
12 secondary outcomes
Change in radiating leg pain intensity (NRS)
Time frame: Week 1, 2-5, 6, 9, 13, 25
Low back pain Visual Analogue Scale (VAS)
Time frame: Week 1, 2-5, 6, 9, 13, 25
Radiating leg pain Visual Analogue Scale (VAS)
Time frame: Week 1, 2-5, 6, 9, 13, 25
Oswestry Disability Index (ODI)
Time frame: Weeks 1, 6, 13, 25
6-item Roland-Morris Disability Questionnaire (RMDQ-6)
Time frame: Weeks 1, 6, 13, 25
Patient Global Impression of Change (PGIC)
Time frame: Week 6, 13, 25
Health-related Quality of Life (EQ-5D-5L)
Time frame: Weeks 1, 6, 13, 25
HINT-8 (Health-related Quality of Life Instrument)
Time frame: Weeks 1, 6, 13, 25
Analgesic consumption
Time frame: Week 1, 2-5, 6, 9, 13, 25
Credibility and Expectancy Questionnaire
Time frame: Screening
Work Productivity and Activity Impairment Questionnaire (WPAI)
Time frame: Week 1, 2-5, 6, 9, 13, 25
Economic evaluation variables
Time frame: Week 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hominis placental pharmacopuncture and Tanscutaneous electrical nerve stimulation (TENS) in people with Chronic Low Back Pain (CLBP), run by Jaseng Medical Foundation at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact In-Hyuk Ha, Dr (+82-1577-0007, hanihata@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in low back pain intensity (NRS) (time frame: Week 1, 2-5, 6, 9, 13, 25). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.