Evaluating Safety and Effectiveness of Ultrasound-Guided Pharmacopuncture for Adults with Spinal Diseases A Multi-Center Registry Study Across Six Korean Medicine Hospitals

What this Trial Is About

Researchers are evaluating the safety and effectiveness of ultrasound-guided pharmacopuncture for patients diagnosed with spinal diseases. This multi-center observational registry study will enroll 600 adults aged 19 to under 70 years with significant spinal pain, including neck pain with upper limb radiating pain or low back pain with lower limb radiating pain. Participants must have a pain Numeric Rating Scale NRS score of 5 or higher for their dominant spinal pain. The study collects real-world data from six Korean medicine hospitals, observing patients who are already planned to receive this treatment as part of their routine care. The ultrasound-guided pharmacopuncture procedure involves a Korean medicine doctor using ultrasound imaging during injection to identify high-risk structures and guide the injection to target tissues in real time. Participants receive this intervention based on their clinicians routine medical judgment, not specifically for the study. Data will be gathered at baseline and at weeks 1, 2, 4, and 8. The study includes detailed recording of treatment methods, concurrent therapies, and adverse events to assess safety. Participants will be monitored through regular visits where pain intensity using NRS, functional disability using Neck Disability Index or Oswestry Disability Index, quality of life using EQ-5D-5L, and patient satisfaction will be assessed. Safety is closely observed by tracking all adverse events at each visit, including their severity and relation to the procedure. The total observation period is 8 weeks, with data securely managed and ethical standards upheld throughout the study.

Safety and Effectiveness of Ultrasound-guided Pharmacopuncture for Spinal Diseases