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.
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Parallel
Ultrasound-guided Deep Pharmacopuncture Treatment
Procedure/SurgeryParticipants 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.
Korean medical treatment
Procedure/Surgeryacupuncture 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.
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.
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.
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.
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.
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