NCT06572579

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2024

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 22, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 27, 2024

Completed
27 days until next milestone

Study Start

First participant enrolled

September 23, 2024

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2025

Completed
Last Updated

October 2, 2025

Status Verified

September 1, 2024

Enrollment Period

22 days

First QC Date

July 22, 2024

Last Update Submit

October 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Adverse Event

    Adverse events assessment

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

Secondary Outcomes (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

  • EQ-5D-5L

    Week 0, 2, 4, 8, 12

  • Patient satisfaction

    Week 4

Study Arms (1)

Ultrasound-guided pharmacopuncture group

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

Procedure: Ultrasound-guided pharmacopuncture treatment

Interventions

Pharmacopuncture treatment using ultrasound-guidance

Ultrasound-guided pharmacopuncture group

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Jaseng Hospital of Korean medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

Bucheon Jaseng Hospital of Korean Medicine

Bucheon-si, Gyeonggi Province, 14598, South Korea

Location

Daejeon Jaseng Hospital of Korean medicine

Daejeon, Seo-gu, South Korea

Location

MeSH Terms

Conditions

Neck PainBack Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • In-Hyuk Ha, Dr

    Jaseng Medical Foundation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
12 Weeks
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2024

First Posted

August 27, 2024

Study Start

September 23, 2024

Primary Completion

October 15, 2024

Study Completion

February 7, 2025

Last Updated

October 2, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations