A Pilot Registry for Ultrasound-guided Pharmacopuncture

October 1, 2025 updated by: Jaseng Medical Foundation

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
    • Gangnam-Gu
      • Seoul, Gangnam-Gu, South Korea, 135-896
        • Jaseng Hospital of Korean Medicine
    • Gyeonggi Province
      • Bucheon-si, Gyeonggi Province, South Korea, 14598
        • Bucheon Jaseng Hospital of Korean Medicine
    • Seo-gu
      • Daejeon, Seo-gu, South Korea
        • Daejeon Jaseng Hospital of Korean Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with spinal disorders who have undergone ultrasound-guided pharmacopuncture treatment

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ultrasound-guided pharmacopuncture group
Patients diagnosed with spinal disorders who have undergone ultrasound-guided pharmacopuncture treatment
Procedure: Ultrasound-guided pharmacopuncture treatment
Pharmacopuncture treatment using ultrasound-guidance

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Event
Time Frame: Treatment visits up to 12 weeks, and Week 2, 4, 8, 12 follow-ups
Adverse events assessment
Treatment visits up to 12 weeks, and Week 2, 4, 8, 12 follow-ups

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jaseng Medical Foundation

Investigators

  • Study Director: In-Hyuk Ha, Dr, Jaseng Medical Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2024

Primary Completion (Actual)

October 15, 2024

Study Completion (Actual)

February 7, 2025

Study Registration Dates

First Submitted

July 22, 2024

First Submitted That Met QC Criteria

August 25, 2024

First Posted (Actual)

August 27, 2024

Study Record Updates

Last Update Posted (Estimated)

October 2, 2025

Last Update Submitted That Met QC Criteria

October 1, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JS-CT-2024-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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