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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05020938
Other study ID # JS-CT-2021-12
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2021
Est. completion date December 30, 2021

Study information

Verified date January 2022
Source Jaseng Medical Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to reveal the effectiveness and satisfaction of integrative Korean medicine for Meniscus Tear by observation patients treated with integrative Korean medicine. This study is a prospective observational study. The subjects for study are patients diagnosed with Meniscus Tear and who have been admitted to Gangnam Jaseng Hospital of Korean medicine, Bucheon Jaseng Hospital of Korean medicine, Daejeon Jaseng Hospital of Korean medicine and Haeundae Jaseng Hospital of Korean medicine for 2015.06-2020.06.


Description:

Medical records of selected patients will be analyzed, and telephone surveys will be conducted for each patient. The survey questions are Numeric rating scale (NRS), Western Ontario and McMasters Universities(WOMAC) Osteoarthritis Index, quality of life, and Patient Global Impression of Change (PGIC), etc.


Recruitment information / eligibility

Status Completed
Enrollment 86
Est. completion date December 30, 2021
Est. primary completion date November 15, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: 1. Patients who have been diagnosed with "Meniscus Tear" in the EMR imaging (X-ray or MRI or CT) of hospitalization 2. Patients who have been hospitalized by Knee Pain 3. A person who voluntarily orally agrees to participate in a clinical trial Exclusion Criteria: 1. If the hospitalization period is less than 3 days, 2. If there are other chronic diseases that may interfere with the treatment effect or interpretation of the results: cardiovascular disease, kidney disease, diabetic neuropathy, dementia, epilepsy, etc. 3. If the cause of pain is caused by a soft tissue disease other than Knee joint: tumor, fibromyalgia, rheumatoid arthritis, gout, etc. 4. Patients within 3 months of surgery on the hip joint 5. If there is a fracture of the joint in the image finding 6. If researchers judge that it is inappropriate to participate in the study; 7. If you do not agree to participate in the study; 8. Minors

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Korea, Republic of Jaseng Hospital of Korean Medicine Seoul Gangnam-Gu

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
Primary Numeric Rating Scale (NRS) NRS uses an 11-point scale to evaluate current knee pain where no pain is indicated by '0', and the worst pain imaginable by '10'. NRS was assessed at admission, 2 weeks after admission, discharge, and long term follow up. Finish survey by August 2021
Secondary Western Ontario and McMasters Universities(WOMAC) Osteoarthritis Index Knee Pain intensity scale Finish survey by August 2021
Secondary EuroQol 5 Dimension (EQ 5D 5L) 5 Level Quality of life Finish survey by August 2021
Secondary Patient Global Impression of Change (PGIC) PGIC is an indicator that evaluates the improvement of patients in 5 steps, and the subject responds with improvement of functional limitation after treatment with 5 likert. (1=completely improved, 2=distinctly improved, 3=improved, 4=no significant difference, 5=worsened) Finish survey by August 2021
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