Traffic AccidentNCT05658939
Safety and Effectiveness of Integrative Korean Medicine Treatment for Traffic Accident During Pregnancy
An observational study of Traffic Accident, run by Jaseng Medical Foundation at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Traffic Accident
- What is being tested?
- Phone/Internet survey
- How many people
- 126 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 May 2022to 18 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Daejeon Jaseng Hospital of Korean Medicine
Daejeon, 35262
About this study
Official title: 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.
Read the 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.
- Conditions
- Traffic Accident
- Being tested
- Phone/Internet survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone/Internet surveyOther
A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over the phone/internet for patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Finish survey by August 2022
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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).
Measured: Finish survey by August 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start2 May 2022
- Primary completion22 Jul 2022
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traffic AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunah Kim, Principal investigator, Daejeon Jaseng Hospital of Korean Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658939
- Sponsor's protocol ID
- JS-CT-2022-05
- Status last verified
- Mar 2024
- First submitted
- 9 Nov 2022
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Integrative Korean Medicine Treatment for Traffic Accident During Pregnancy : Retrospective Chart Review Study and Survey Research
- ClinicalTrials.gov ID
- NCT05658939
- Acronym / sponsor ID
- JS-CT-2022-05
- Conditions
- Traffic Accident
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 2 May 2022 (actual)
- Primary completion
- 22 Jul 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone/Internet surveyA questionnaire about the current symptoms and satisfaction for received treatment will be conducted over the phone/internet for patients. | Other | – |
Primary outcome
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.
6 secondary outcomes
Effectiveness Outcome : Neck Disability Index (NDI)
Time frame: Finish survey by August 2022
Effectiveness Outcome : Oswestry Disability Index (ODI)
Time frame: Finish survey by August 2022
Effectiveness Outcome : Shoulder Pain and Disability Index (SPADI)
Time frame: Finish survey by August 2022
Effectiveness Outcome : The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Finish survey by August 2022
Effectiveness Outcome : EuroQol 5-dimension 5-level (EQ-5D-5L)
Time frame: Finish survey by August 2022
Effectiveness Outcome : Patient Global Impression of Change (PGIC)
Time frame: Finish survey by August 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunah Kim principal investigator
Daejeon Jaseng Hospital of Korean Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Traffic Accident, run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness Outcome : Numeric rating scale (NRS) (time frame: Finish survey by August 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.