Ultrasound-guided Pharmacopuncture Spinal Disease Registry Trial, 600 Patients, 6 Sites
Summary
The NIH ClinicalTrials.gov registry has posted an observational multi-center registry study (NCT07543692) evaluating the safety and effectiveness of ultrasound-guided pharmacopuncture for patients with spinal diseases. The study will enroll 600 patients aged 19 to under 70 across six Korean medicine hospitals, requiring a pain Numeric Rating Scale score of 5 or higher for eligibility. Participants already planned to receive ultrasound-guided pharmacopuncture as part of routine clinical care will be observed; the primary outcome is change in most dominant spinal pain intensity from baseline to 4 weeks. Secondary outcomes include functional disability (NDI/ODI), quality of life (EQ-5D-5L), and patient satisfaction, with safety monitored via adverse event assessment at every visit. This is a non-interventional registry study with no new compliance obligations for external parties.
“A total of 600 patients, aged 19 to under 70 years, will be enrolled across six Korean medicine hospitals.”
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What changed
This entry registers a new observational multi-center registry study on ClinicalTrials.gov, NCT07543692, titled 'Safety and Effectiveness of Ultrasound-guided Pharmacopuncture for Spinal Diseases: A Multi-center, Registry Study.' The study will follow 600 patients across six Korean medicine hospitals for 4 weeks, assessing pain intensity via NRS as the primary outcome, with secondary assessments of functional disability, quality of life, and patient satisfaction.
For compliance officers and clinical research professionals, this registry entry documents an observational study involving pharmacopuncture—a Korean medicine intervention—applied to patients with neck pain or low back pain with radiculopathy. No new regulatory obligations are created; the study appears to follow standard observational research protocols with IRB/ethics oversight, informed consent, and adverse event monitoring as described in the registry record. Organizations conducting or reviewing similar integrative medicine trials may find this registry useful as a reference for endpoint design and eligibility criteria.
Archived snapshot
Apr 22, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Safety and Effectiveness of Ultrasound-guided Pharmacopuncture for Spinal Diseases: A Multi-center, Registry Study
Observational NCT07543692 Kind: OBSERVATIONAL Apr 22, 2026
Abstract
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.
Conditions: Spinal Disease, Neck Pain, Low Back Pain, Radiculopathy
Interventions: Ultrasound-guided Pharmacopuncture
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