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Clinical Trials/NCT05658939
NCT05658939
Completed
Not Applicable

Safety and Effectiveness of Integrative Korean Medicine Treatment for Traffic Accident During Pregnancy : Retrospective Chart Review Study and Survey Research

Jaseng Medical Foundation1 site in 1 country126 target enrollmentMay 2, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Traffic Accident
Sponsor
Jaseng Medical Foundation
Enrollment
126
Locations
1
Primary Endpoint
Effectiveness Outcome : Numeric rating scale (NRS)
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The purpose of this study is to reveal the efficacy and safety of integrative korean medicine treatment for pregnant women who suffered a traffic accident. A retrospective chart review and follow-up were conducted.

From January 1, 2018 to April 22, 2022, pregnant women who visited an korean medicine hospital due to a traffic accident were subjected to a retrospective study of patient medical records and follow-up.

Detailed Description

Medical records of selected patients will be analyzed, and telephone or internet surveys will be conducted for each patient. The survey questions are Numeric rating scale(NRS), Neck disability index(NDI) score, Oswestry Disability Index(ODI) score, Shoulder Pain and Disability Index(SPADI) score, The Western Ontario and McMaster Universities Osteoarthritis Index(WOMAC) score, EuroQol 5-dimension 5-level(EQ-5D-5L) score and patient global impression of change (PGIC) score, etc.

Registry
clinicaltrials.gov
Start Date
May 2, 2022
End Date
August 18, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients who visited hospital due to symptoms caused by a traffic accident during pregnancy and received one or more korean medicine treatment as an inpatient or outpatient treatment
  • Patients who understand the purpose and contents of the study and agree to participate in the study
  • Patients with communication skills and mental/physical ability to respond appropriately to questionnaires

Exclusion Criteria

  • Patients under the age of 18 at the time of the first visit
  • Patients who received treatment without being aware of pregnancy
  • Patients who have undergone only consultation or Western treatment at the hospital
  • Patients whose participation in the study is difficult for the researcher to judge

Outcomes

Primary Outcomes

Effectiveness Outcome : Numeric rating scale (NRS)

Time Frame: Finish survey by August 2022

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'. NRS scores were collected for each patient's chief complaints. For outpatients, the NRS scores on the first and last outpatient visit days, and for inpatients, the NRS scores on the day of admission and discharge were collected through the electronic medical records(EMRs). In the follow-up questionnaire, the current NRS score was also collected for each patient's chief complaints.

Secondary Outcomes

  • Effectiveness Outcome : Neck Disability Index (NDI)(Finish survey by August 2022)
  • Effectiveness Outcome : Shoulder Pain and Disability Index (SPADI)(Finish survey by August 2022)
  • Effectiveness Outcome : Oswestry Disability Index (ODI)(Finish survey by August 2022)
  • Effectiveness Outcome : The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Finish survey by August 2022)
  • Effectiveness Outcome : EuroQol 5-dimension 5-level (EQ-5D-5L)(Finish survey by August 2022)
  • Effectiveness Outcome : Patient Global Impression of Change (PGIC)(Finish survey by August 2022)

Study Sites (1)

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