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

NCT07126951 | Not Yet Recruiting DMC

• 1 other identifier: JS-CT-2025-08
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain (LBP)

Keywords

pharmacopuncture; Ultrasound Guiding

Outcome Measures

Primary Outcomes (1)

• 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.

  Day1, Baseline(day2), day3, day4, day5, 2week after enrollment, 4week after enrollment

Secondary Outcomes (6)

• Radiating pain intensity scale: Numeric Rating Scale(NRS)

  Day1, Baseline(day2), day3, day4, day5, 2week after enrollment, 4week after enrollment

• Oswestry Disability Index (ODI)

  Baseline(day2), day5, 2week after enrollment, 4week after enrollment

• EuroQol-5D-5L (EQ-5D)

  Baseline(day2), day5, 2week after enrollment, 4week after enrollment

• Physical Examination - Lumbar Active Range of Motion (AROM)

  Baseline(day2), day3, day4, day5

• Patient Global Impression of Change (PGIC)

  day5, 2week after enrollment, 4week after enrollment

Study Arms (2)

Ultrasound-guided Deep Pharmacopuncture Treatment

EXPERIMENTAL

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: Korean medical treatment

Korean medical treatment

ACTIVE COMPARATOR

The control group were received Korean medical treatment everyday after hospitalization: acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.

Procedure: Ultrasound-guided Deep Pharmacopuncture Treatment; Procedure: Korean medical treatment

Interventions

Ultrasound-guided Deep Pharmacopuncture Treatment PROCEDURE

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.

Korean medical treatment

Korean medical treatment PROCEDURE

acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine

Korean medical treatment; Ultrasound-guided Deep Pharmacopuncture Treatment

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Jaseng Hospital of Korean Medicine

Haeundae, Jaseng Hospital of Korean Medicine, 135-896, South Korea

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• In-Hyuk Ha, phD

  Jaseng Medical Foundation

  PRINCIPAL INVESTIGATOR

Central Study Contacts

In-Hyuk Ha, phD

CONTACT

02-2222-2740; hanitata@jaseng.co.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A Pragmatic randomized controlled trial

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 17, 2025
• Study Start: March 30, 2026
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)