NCT04855058

Brief Summary

The purpose of this study is to reveal the effectiveness of integrative Korean medicine for trauma fracture by observation inpatients treated with integrative Korean medicine. This study is a prospective observational study. The subjects for study are patients diagnosed with fracture and who have been admitted to five Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, Bundang and Haeundae) for 2017.03-2020.08. Medical records of selected patients will be analyzed, and online google surveys(or telephone) will be conducted for each patient. The survey questions are Numeric rating scale (NRS), quality of life, and Patient Global Impression of Change (PGIC), etc.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
665

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 29, 2021

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

February 8, 2022

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

April 12, 2021

Last Update Submit

January 25, 2022

Conditions

Fractures, BoneMedicine, Korean Traditional

Keywords

acupuncture therapyherbal medicine

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Numeric rating scale(NRS) to longterm f/u survey

    NRS uses an 11-point scale to evaluate current neck pain and radiating pain where no pain is indicated by '0', and the worst pain imaginable by '10'.

    baseline(admission), week 1, 2, 3, 4, 5, 6, 7, day of Discharge(up to week 8), finish f/u survey by June 2021

Secondary Outcomes (11)

  • The five level version of EuroQol-5 Dimension (EQ-5D)

    baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021

  • Oswestry disability index (ODI)

    baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021

  • Neck Disability Index (NDI)

    baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021

  • Shoulder Pain and Disability Index (SPADI)

    baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021

  • The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    baseline(admission), week 2, 4, 6, day of Discharge(up to week 8), finish f/u survey by June 2021

  • +6 more secondary outcomes

Interventions

online survey(or phone survey)OTHER

A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over google survey(or the phone survey) for patients.

Eligibility Criteria

Age19 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The subjects for study are patients diagnosed with fracture and who have been admitted to five Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, Bundang and Haeundae) for 2017.03-2020.08.

You may qualify if:

  • years old
  • Pateints who have been admitted to five Jaseng Hospital of Korean medicine (Gangnam, Bucheon, Daejeon, Bundang and Haeundae) and hospitalized 5 days or more
  • fracture caused by trauma
  • Patients have agreed to participate the study.

You may not qualify if:

  • pathological fracture, stress fracture
  • Open fracture
  • The cause of pain is due to other disease, not the fracture: tumors, fibromyalgia, rheumatoid arthritis, gout, etc.
  • Patients who are difficult to complete the research questionaire because of communication, mental or physical capabilities.
  • lack of data of collection
  • Patients deemed unable to participate in the clinical research by other researchers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jaseng Medical Foundation

Seoul, South Korea

Location

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

April 12, 2021

First Posted

April 22, 2021

Study Start

March 29, 2021

Primary Completion

August 31, 2021

Study Completion

December 31, 2021

Last Updated

February 8, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)