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

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

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.

Study Overview

• Status: Completed
• Conditions: Meniscus Tear
• Intervention / Treatment: Other: phone survey

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gangnam-Gu
    • Seoul, Gangnam-Gu, Korea, Republic of, 135-896
      • Jaseng Hospital of Korean Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The target is those who showed Meniscus Tear in video findings among patients admitted to Gangnam Mainwon, Daejeon, and Bucheon Haeundae, four branches of Hospitals with Knee pain from June 2015 to June 30, 2020.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario and McMasters Universities(WOMAC) Osteoarthritis Index	Knee Pain intensity scale	Finish survey by August 2021
EuroQol 5 Dimension (EQ 5D 5L)	5 Level Quality of life	Finish survey by August 2021
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

Collaborators and Investigators

• Sponsor: Jaseng Medical Foundation
• Investigators: Study Director: In-Hyuk Ha, Ph.D, Jaseng Medical Foundation

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2021
• Primary Completion (Actual): November 15, 2021
• Study Completion (Actual): December 30, 2021

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): January 14, 2022
• Last Update Submitted That Met QC Criteria: January 12, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: JS-CT-2021-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No