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

Completed

• Conditions: Traffic Accident

• Registration Number: NCT05658939
• Lead Sponsor: Jaseng Medical Foundation

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.

Study Timeline

• Study Start: 2022-05-02
• Primary Completion: 2022-07-22
• Study Completion: 2022-08-18
• Study First Submitted: 2022-11-09
• Study First Submitted QC: 2022-12-20
• Study First Posted: 2022-12-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-03
• Last Update Posted: 2024-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 126

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Effectiveness Outcome : Numeric rating scale (NRS)	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 Outcome Measures

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

Trial Locations

Locations (1)

Daejeon Jaseng Hospital of Korean Medicine; 🇰🇷 Daejeon, Korea, Republic of