Safety and Effectiveness of Ultrasound-guided Pharmacopuncture for Spinal Diseases (NCT07543692) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Safety and Effectiveness of Ultrasound-guided Pharmacopuncture for Spinal Diseases
South Korea600 participantsStarted 2026-04-28
Plain-language 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.
Who can participate
Age range19 Years – 69 Years
SexALL
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Inclusion criteria
✓. Patients diagnosed with spinal diseases (KCD codes M and S).
✓. Patients whose Numeric Rating Scale (NRS) score for the most predominant pain (neck pain with upper limb radiating pain OR low back pain with lower limb radiating pain) caused by spinal diseases is 5 or higher.
✓. Outpatients or inpatients scheduled to utilize an ultrasound scan during pharmacopuncture (the decision to perform ultrasound-guided pharmacopuncture is made according to the clinician's routine medical judgment, not for research purposes).
✓. Patients who voluntarily agree to participate in the clinical study and sign the informed consent form.
Exclusion criteria
✕. Patients who have difficulty completing the written informed consent form.
✕. Women who are pregnant, planning to become pregnant, or breastfeeding.
✕. Patients deemed inappropriate for study participation by the investigator due to severe underlying diseases (e.g., cancer or other malignant neoplasms) that may interfere with treatment effects or result interpretation.
What they're measuring
1
Change in Pain Intensity : Numeric Rating Scale (NRS)