A Pilot Registry for Ultrasound-guided Pharmacopuncture

Recruiting

• Conditions: Neck Pain; Back Pain
• Interventions: Procedure: Ultrasound-guided pharmacopuncture treatment

• Registration Number: NCT06572579
• Lead Sponsor: Jaseng Medical Foundation

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.

Study Timeline

• Study First Submitted: 2024-07-22
• Study First Submitted QC: 2024-08-25
• Study First Posted: 2024-08-27
• Status Verified: 2024-09
• Study Start: 2024-09-23
• Last Update Submitted: 2024-09-26
• Last Update Posted: 2024-09-30
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ultrasound-guided pharmacopuncture group	Ultrasound-guided pharmacopuncture treatment	Patients diagnosed with spinal disorders who have undergone ultrasound-guided pharmacopuncture treatment

Primary Outcome Measures

Name	Time	Method
Adverse Event	Treatment visits up to 12 weeks, and Week 2, 4, 8, 12 follow-ups	Adverse events assessment

Secondary Outcome Measures

Name	Time	Method
EQ-5D-5L	Week 0, 2, 4, 8, 12	Quality of life using EQ-5D-5L
Patient satisfaction	Week 4	Patient satisfaction survey
Spinal pain numeric rating scale	Week 0, Treatment visits up to 12 weeks, and Week 2, 4, 8, 12 follow-ups	Spinal pain numeric rating scale
Disability index	Week 0, 2, 4, 8, 12	Neck disability index or Oswestry Disability Index

Trial Locations

Locations (3)

Jaseng Hospital of Korean medicine; 🇰🇷 Seoul, Gangnam-Gu, Korea, Republic of

Bucheon Jaseng Hospital of Korean Medicine; 🇰🇷 Bucheon, Gyeonggi Province, Korea, Republic of

Daejeon Jaseng Hospital of Korean medicine; 🇰🇷 Daejeon, Seo-gu, Korea, Republic of