Pilot Study: Clinical Trial of Ultrasound Guiding Pharmacopuncture Therapy for Acute Low Back Pain

Not Applicable

Not yet recruiting

• Conditions: Low Back Pain (LBP)

• Registration Number: NCT07126951
• Lead Sponsor: Jaseng Medical Foundation

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-17
• Last Update Posted: 2025-08-17
• Study Start: 2025-10-30
• Primary Completion: 2026-04-30
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

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 informed consent voluntarily.

Exclusion Criteria

Participants will be excluded if they meet any of the following:

Diagnosed with serious underlying conditions causing back pain (e.g., malignancy, 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., steroids, immunosuppressants, psychiatric drugs).

Contraindicated 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 informed consent form.

Deemed inappropriate for participation by the investigator for any other reason.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Low back Pain intensity scale: Numeric Rating Scale(NRS)	Day1, Baseline(day2), day3, day4, day5, 2week after enrollment, 4week after enrollment	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.

Secondary Outcome Measures

Name	Time	Method
Physical Examination - Lumbar Active Range of Motion (AROM)	Baseline(day2), day3, day4, day5	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.
Adverse Events (AE)	Baseline(day2), day3, day4, day5, 2week after enrollment, 4week after enrollment	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.
Radiating pain intensity scale: Numeric Rating Scale(NRS)	Day1, Baseline(day2), day3, day4, day5, 2week after enrollment, 4week after enrollment	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)	Baseline(day2), day5, 2week after enrollment, 4week after enrollment	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)	Baseline(day2), day5, 2week after enrollment, 4week after enrollment	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.
Patient Global Impression of Change (PGIC)	day5, 2week after enrollment, 4week after enrollment	PGIC is a 7-point scale where patients rate their overall improvement following treatment, ranging from "very much improved" to "very much worse."

Trial Locations

Locations (1)

Jaseng Hospital of Korean Medicine; 🇰🇷 Seoul, aseng Hospital of Korean Medicine, Korea, Republic of