RecruitingNCT07543692

Safety and Effectiveness of Ultrasound-guided Pharmacopuncture for Spinal Diseases

Safety and Effectiveness of Ultrasound-guided Pharmacopuncture for Spinal Diseases: A Multi-center, Registry Study


Sponsor

Jaseng Medical Foundation

Enrollment

600 participants

Start Date

Apr 29, 2026

Study Type

OBSERVATIONAL

Conditions

Summary

This multi-center registry study aims to evaluate the safety and effectiveness of ultrasound-guided pharmacopuncture for patients diagnosed with spinal diseases. A total of 600 patients, aged 19 to under 70 years, will be enrolled across six Korean medicine hospitals. Eligible participants must have a pain Numeric Rating Scale (NRS) of 5 or higher for their most dominant spinal pain, which includes neck pain with upper extremity radiating pain, or low back pain with lower extremity radiating pain. As a non-interventional observational study, it will include patients who are already planned to receive ultrasound-guided pharmacopuncture as part of their routine clinical care. The primary outcome is the change in the most dominant spinal pain intensity measured by the NRS from baseline to 4 weeks. Secondary outcomes include functional disability evaluated using the Neck Disability Index (NDI) or Oswestry Disability Index (ODI), quality of life using the EQ-5D-5L, and patient satisfaction. Safety will be closely monitored by assessing all adverse events at every visit, evaluating their incidence, severity, and causality related to the procedure. 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.


Eligibility

Min Age: 19 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Ultrasound-guided Pharmacopuncture for people with low back pain, neck pain, and other related conditions. The study is currently recruiting participants at 6 locations. People eligible for this study include aged 19 Years to 69 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREUltrasound-guided Pharmacopuncture

This is a procedure in which a Korean medicine doctor utilizes an ultrasound imaging device during pharmacopuncture injection for either of the following two purposes: 1. Screening purpose: To pre-examine and identify the locations of high-risk structures, such as major nerves and blood vessels, prior to the injection. 2. Guiding purpose: To observe the injection pathway and target tissues in real-time while administering the pharmacopuncture fluid into the acupoints and targets. In this study, this intervention is not assigned for research purposes; rather, it is performed entirely according to the clinician's routine medical judgment and clinical care plan.


Locations(6)

Daejeon Jaseng Hospital of Korean Medicine

Daejeon, Daejeon, South Korea

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-gu, South Korea

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, GGyeonggi-do, South Korea

Kyung Hee University Korean Medicine Hospital

Seoul, South Korea

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

School of Korean Medicine, Pusan National University

Yangsan, South Korea

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NCT07543692


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