Safety and Effectiveness of Integrative Korean Medicine Treatment for Traffic Accident During Pregnancy

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

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.

Study Overview

• Status: Completed
• Conditions: Traffic Accident
• Intervention / Treatment: Other: Phone/Internet survey

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.

• Study Type: Observational
• Enrollment (Actual): 126

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daejeon, Korea, Republic of, 35262
    • Daejeon Jaseng Hospital of Korean Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

From January 1, 2018 to April 22, 2022, patients who visited Daejeon Jasaeng Korean Medicine Hospital due to a traffic accident during pregnancy were included.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness Outcome : Numeric rating scale (NRS)	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.	Finish survey by August 2022

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness Outcome : Neck Disability Index (NDI)	The NDI questionnaire is a 10-item questionnaire designed to evaluate functional disorders related to the cervical spine. Each item consists of 6 levels ranging from 0 to 5, and the higher the score, the more severe the functional impairment.	Finish survey by August 2022
Effectiveness Outcome : Oswestry Disability Index (ODI)	The ODI is a 10-item questionnaire developed to evaluate the degree of disability for low back pain. Each item is divided into 6 levels, and 0 to 5 points are awarded. The higher the score, the greater the degree of disability. We will conduct an validated Korean ODI questionnaire.	Finish survey by August 2022
Effectiveness Outcome : Shoulder Pain and Disability Index (SPADI)	The SPADI is a questionnaire designed to evaluate functional impairments related to the shoulder and consists of two dimensions: the pain dimension, 5 questions; the functional activities, 8 questions. Each item consists of 0-10 points, and the higher the score, the more severe the shoulder dysfunction.	Finish survey by August 2022
Effectiveness Outcome : The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	The WOMAC is a questionnaire evaluation tool designed to evaluate the joint function of the knee joint and consists of three subscales: pain, 5 questions; stiffness, 2 questions; physical function, 17 questions. Each item consists of 1-5 points, and the higher the score, the worse the condition of the knee joint.	Finish survey by August 2022
Effectiveness Outcome : EuroQol 5-dimension 5-level (EQ-5D-5L)	EQ-5D is most widely used as a method of indirectly calculating the quality of life from various aspects. The EQ-5D-5L consists of 5 questions (mobility, self-care, usual activities, pain, anxiety/depression) that ask about the current state of health, and answers each question with 5 likert. (1=I have no problems about, 2=I have slight problems about, 3=I have moderate problems about, 4=I have severe problems about, 5=I am unable to about) In this study, the validated Korean version questionnaire will be used	Finish survey by August 2022
Effectiveness Outcome : Patient Global Impression of Change (PGIC)	PGIC is an indicator that evaluates the improvement of patients in 7 steps, and the subject responds with improvement of functional limitation after treatment with 7 likert. (1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse).	Finish survey by August 2022

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survey ( Obstetric and neonatal outcomes checklist)	Obstetric and neonatal outcomes	Finish survey by August 2022
Number of participants with Symptoms related/not related to pregnancy	Symptoms related/not related to pregnancy	Finish survey by August 2022

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation
• Investigators: Principal Investigator: Sunah Kim, Daejeon Jaseng Hospital of Korean Medicine

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2022
• Primary Completion (Actual): July 22, 2022
• Study Completion (Actual): August 18, 2022

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: December 20, 2022
• First Posted (Actual): December 21, 2022

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 3, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: JS-CT-2022-05

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