Safety and Effectiveness of Ultrasound-guided Pharmacopuncture for Spinal Diseases: A Pilot Registry

Jaseng Medical Foundation3 sites in 1 country50 target enrollmentSeptember 23, 2024

ConditionsNeck Pain Back Pain

Overview

Phase: N/A
Intervention: Not specified
Conditions: Neck Pain
Sponsor: Jaseng Medical Foundation
Enrollment: 50
Locations: 3
Primary Endpoint: Adverse Event
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

A pilot study of prospective resigstry to evaluate the safety and efficacy of ultrasound-guided pharmacopuncture for spinal disorders

Detailed Description

This study aims to evaluate the safety and efficacy of ultrasound-guided pharmacopuncture by collecting information on adverse reactions, efficacy assessment variables, and treatment methods from patients diagnosed with spinal disorders who have undergone ultrasound-guided pharmacopuncture treatment.

Registry

clinicaltrials.gov

Start Date

September 23, 2024

End Date

February 7, 2025

Last Updated

7 months ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Jaseng Medical Foundation

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Individuals diagnosed with spinal disorders (M code and S code based on KCD criteria)
•Outpatients scheduled for ultrasound-guided pharmacopuncture treatment
•Individuals aged 19 years or older and under 70 years
•Individuals who agree to participate in the clinical study and voluntarily sign the consent form

Exclusion Criteria

•Individuals who are unable to complete the consent form
•Individuals who are deemed unsuitable for participation in the clinical study by the researcher

Outcomes

Primary Outcomes

Adverse Event

Time Frame: Treatment visits up to 12 weeks, and Week 2, 4, 8, 12 follow-ups

Adverse events assessment

Secondary Outcomes

EQ-5D-5L(Week 0, 2, 4, 8, 12)
Patient satisfaction(Week 4)
Spinal pain numeric rating scale(Week 0, Treatment visits up to 12 weeks, and Week 2, 4, 8, 12 follow-ups)
Disability index(Week 0, 2, 4, 8, 12)