An interventional study of Ultrasound-guided Deep Pharmacopuncture Treatment and Korean medical treatment in Low Back Pain (LBP), sponsored by Jaseng Medical Foundation. Not yet recruiting at 1 site in South Korea. Open to participants aged 19 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by Jaseng Medical Foundation · Not applicable, Interventional, and Treatment
This pilot randomized controlled clinical trial aims to evaluate the effectiveness and safety of ultrasound-guided deep pharmacopuncture therapy for acute low back pain (LBP) that occurs within seven days following a traffic accident. While traditional Korean medicine-including acupuncture, herbal medicine, pharmacopuncture, and Chuna manual therapy-is commonly used for post-accident injuries, few studies have focused on deep pharmacopuncture administered under ultrasound guidance. This study will provide preliminary evidence to assess whether ultrasound-guided techniques offer added clinical benefits.
A total of 40 patients hospitalized at Jaseng Hospital of Korean Medicine in Haeundae, Korea, will be recruited and randomly assigned into two groups: the intervention group will receive integrative Korean medicine therapy plus ultrasound-guided pharmacopuncture, while the control group will receive integrative Korean medicine therapy alone. Both groups will undergo treatment during hospitalization, with the pharmacopuncture administered up to three times between hospital day 2 and day 4 in the intervention group. Baseline assessment will be done on day 2 before treatment, and the primary outcome will be measured on day 5. Follow-up assessments will be conducted at 2 and 4 weeks via telephone.
The primary outcome is the change in low back pain intensity as measured by the Numeric Rating Scale (NRS). Secondary outcomes include radiating pain, lumbar range of motion, Oswestry Disability Index (ODI), EQ-5D for quality of life, and the Patient Global Impression of Change (PGIC). Adverse events will also be monitored and classified according to established safety criteria.
This study will utilize both intention-to-treat (ITT) and per-protocol (PP) analyses, with linear mixed models and multiple imputation used to address missing data. Given the limited existing evidence on ultrasound-guided deep pharmacopuncture, this trial is designed to explore its feasibility and provide the groundwork for future large-scale trials.
Participants will be selected based on strict inclusion and exclusion criteria to ensure safety and consistency. Ethical standards including informed consent, data privacy, and ongoing safety monitoring will be rigorously upheld throughout the study.
This pragmatic, randomized, controlled pilot study investigates the comparative clinical effectiveness and safety of ultrasound-guided deep pharmacopuncture versus conventional integrative Korean medicine treatment for acute low back pain (LBP) occurring within 7 days after a traffic accident.
The study will enroll 40 hospitalized patients aged 19-70 who report moderate to severe acute LBP (NRS ≥5) and have disc narrowing visible on lumbar X-rays. Participants will be randomly assigned to one of two treatment arms (n=20 per group) using a block randomization procedure. The trial will proceed through a screening/enrollment phase, active inpatient treatment, and follow-up evaluations at 2 and 4 weeks post-enrollment.
The intervention group will receive a combination of standard integrative Korean medicine treatment and 1 to 3 sessions of ultrasound-guided deep pharmacopuncture between hospital day 2 and 4. The control group will receive standard care only, which includes acupuncture, non-ultrasound-guided pharmacopuncture, herbal medicine, and Chuna manual therapy.
The primary outcome is change in low back pain intensity (NRS) from baseline (Day 2 pre-treatment) to Day 5. Secondary outcomes include radiating pain, lumbar range of motion (ROM), functional status (Oswestry Disability Index), quality of life (EQ-5D-5L), and overall improvement (Patient Global Impression of Change). Adverse events will be systematically monitored and assessed.
The trial is designed to evaluate the feasibility, effect size estimation, and safety profile of ultrasound-guided pharmacopuncture in preparation for a larger-scale confirmatory trial. Analyses will follow both ITT and PP principles, with linear mixed models and imputation techniques for handling missing data.
The study adheres to ethical guidelines, including informed consent, privacy protection, and safety monitoring. Monitoring will be conducted by third parties per KCGP standards to ensure data quality and patient protection.
2,922 studies on the registry are indexed under Low Back Pain; 580 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 2,364 interventional studies indexed under Low Back Pain.
Browse Low Back Pain studies →Jaseng Medical Foundation is the lead sponsor of 69 studies on the registry; 11 are open to participants now.
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Participants must meet all of the following:
Adults aged 19 to 70 years.
Patients who developed acute low back pain within 7 days after a traffic accident.
Numeric Rating Scale (NRS) score of 5 or higher for low back pain.
Radiological evidence of disc narrowing on lumbar spine X-ray.
Complaints of radiating leg pain.
Hospitalized for treatment related to the traffic accident.
Able and willing to provide written voluntarily.
Exclusion Criteria:
Participants will be excluded if they meet any of the following:
Diagnosed with serious underlying conditions causing back pain (e.g., , spinal infection, inflammatory spondylitis).
Presence of progressive or severe neurological deficits.
Underwent lumbar surgery or procedures within the past 3 weeks.
Back pain caused by non-spinal soft tissue disorders (e.g., fibromyalgia, rheumatoid arthritis, gout).
Presence of chronic conditions that could interfere with study results (e.g., cardiovascular disease, renal disease, diabetic neuropathy, dementia, epilepsy).
Taking medications that could affect study outcomes (e.g., , , psychiatric drugs).
or unsafe for acupuncture (e.g., bleeding disorders, anticoagulant therapy, severe diabetes with infection risk, severe cardiovascular conditions).
Currently pregnant or planning pregnancy.
Diagnosed with severe mental illness.
Participation in other clinical trials (excluding observational studies).
Unable to properly complete the form.
Deemed inappropriate for participation by the investigator for any other reason.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm will receive integrative Korean medicine treatment combined with ultrasound-guided deep pharmacopuncture. The integrative treatment includes acupuncture, Chuna manual therapy (focused on cervical and lumbar regions), and oral herbal medicine administered during hospitalization. In addition to these treatments, patients in this group will receive ultrasound-guided pharmacopuncture therapy once daily from Day 2 to Day 4 of hospitalization, for a maximum of three sessions. The pharmacopuncture procedure involves injecting 4 cc of herbal extract into deep lumbar tissue using a 26G sterile needle under real-time ultrasound guidance. The target site is selected based on lumbar spine X-ray findings (disc narrowing) and patient-reported radiating pain. The needle is inserted using an in-plane approach to visualize the needle tip reaching the posterior facet joint of the most symptomatic lumbar segment.
Procedure: Ultrasound-guided Deep Pharmacopuncture Treatment · Procedure: Korean medical treatment
The control group were received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
Procedure: Korean medical treatment
Participants in this group will receive ultrasound-guided deep pharmacopuncture in addition to integrative Korean medicine treatment (acupuncture, herbal medicine, and Chuna therapy). The pharmacopuncture involves injecting 4 cc of herbal extract into deep lumbar tissues, targeting the posterior facet joint of the most symptomatic segment. Using a real-time ultrasound-guided in-plane technique, the needle path and tip are visualized to ensure accurate and safe delivery. Treatment is administered once daily for up to 3 days (hospital Days 2-4). This intervention differs from conventional methods by using ultrasound to guide precise, deep-tissue injection, enhancing both safety and treatment accuracy.
acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine
Low back Pain intensity scale: Numeric Rating Scale(NRS)
The NRS is a numeric scale used to quantify the patient's subjective experience of pain. Patients rate their current low back pain on a scale from 0 to 10, where 0 indicates no pain and 10 represents the worst pain imaginable.
Time frame: Day1, Baseline(day2), day3, day4, day5, 2week after enrollment, 4week after enrollment
Radiating pain intensity scale: Numeric Rating Scale(NRS)
This scale assesses the severity of radiating pain (e.g., pain extending to the legs). Patients rate their current radiating pain on a 0-10 scale, where 0 indicates no pain and 10 indicates the worst possible radiating pain.
Time frame: Day1, Baseline(day2), day3, day4, day5, 2week after enrollment, 4week after enrollment
Oswestry Disability Index (ODI)
The ODI is used to assess functional impairment due to low back pain. It consists of 10 items, each scored from 0 to 5, for a maximum score of 50. The final score is calculated as the average of the answered items and reflects the patient's level of disability in daily life.
Time frame: Baseline(day2), day5, 2week after enrollment, 4week after enrollment
EuroQol-5D-5L (EQ-5D)
EQ-5D is a standardized tool for measuring health-related quality of life. It includes five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on five levels (1 = no problem, 5 = extreme problem). A Korean-specific value set will be applied to calculate utility scores.
Time frame: Baseline(day2), day5, 2week after enrollment, 4week after enrollment
Physical Examination - Lumbar Active Range of Motion (AROM)
This measures the maximum range of motion in the lumbar spine that the patient can achieve without pain. Six movements are assessed: flexion, extension, left and right lateral bending, and left and right rotation. Measurements are taken using a goniometer. If the patient refuses due to severe pain, the result is recorded as 0 degrees.
Time frame: Baseline(day2), day3, day4, day5
Patient Global Impression of Change (PGIC)
PGIC is a 7-point scale where patients rate their overall improvement following treatment, ranging from "very much improved" to "very much worse."
Time frame: day5, 2week after enrollment, 4week after enrollment
Adverse Events (AE)
Any unfavorable and unintended sign, symptom, or disease temporally associated with the treatment will be recorded, regardless of a causal relationship. Events will be monitored and classified by severity (mild, moderate, severe) using Spilker's criteria, and by causality using a 6-point WHO-UMC scale.
Time frame: Baseline(day2), day3, day4, day5, 2week after enrollment, 4week after enrollment
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Jaseng Medical Foundation