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

Traffic Accident Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05658939
• Other study ID #: JS-CT-2022-05
• Status: Completed
• Start date: May 2, 2022
• Est. completion date: August 18, 2022

Study information

• Verified date: March 2024
• Source: Jaseng Medical Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 18, 2022
• Est. primary completion date: July 22, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Traffic Accident

Intervention

Other:
• Phone/Internet survey
A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over the phone/internet for patients.

Locations

Country	Name	City	State
Korea, Republic of	Daejeon Jaseng Hospital of Korean Medicine	Daejeon

Sponsors (1)

Lead Sponsor	Collaborator
Jaseng Medical Foundation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Survey ( Obstetric and neonatal outcomes checklist)	Obstetric and neonatal outcomes	Finish survey by August 2022
Other	Number of participants with Symptoms related/not related to pregnancy	Symptoms related/not related to pregnancy	Finish survey by August 2022
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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