Long Term Follow-Up of KNEE PAIN Patients Accompanying Meniscus Tear

Meniscus Tear Clinical Trial

Official title:

Long Term Follow-Up of KNEE PAIN Patients Accompanying Meniscus Tear Treated With Integrated Complementary and Alternative

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05020938
• Other study ID #: JS-CT-2021-12
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Meniscus Tear

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