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Safety and Effectiveness of Ultrasound-guided Pharmacopuncture for Spinal Diseases

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Notable Recruitment opened
    • Start date changed from estimate of Apr 28, 2026 to Apr 29, 2026
    • Site details revised at 6 of 6 sites
    v3
  2. Minor Secondary endpoints: details revised at 6 of 6 entries
    • Study title shortened, about 4 words
    v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07543692
Lead Sponsor Jaseng Medical Foundation
Conditions
(from sponsor)
Spinal Disease, Neck Pain, Low Back Pain, Radiculopathy
Related terms Low Back Pain, Neck Pain, Radiculopathy, Spinal Diseases
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov