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

NCT05020938 | Completed

• 1 other identifier: JS-CT-2021-12
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Meniscus Tear

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Western Ontario and McMasters Universities(WOMAC) Osteoarthritis Index

  Finish survey by August 2021

• EuroQol 5 Dimension (EQ 5D 5L)

  Finish survey by August 2021

• Patient Global Impression of Change (PGIC)

  Finish survey by August 2021

Interventions

phone survey OTHER

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who have been diagnosed with "Meniscus Tear" in the EMR imaging (X-ray or MRI or CT) of hospitalization
• Patients who have been hospitalized by Knee Pain
• A person who voluntarily orally agrees to participate in a clinical trial

You may not qualify if:

• If the hospitalization period is less than 3 days,
• 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.
• If the cause of pain is caused by a soft tissue disease other than Knee joint: tumor, fibromyalgia, rheumatoid arthritis, gout, etc.
• Patients within 3 months of surgery on the hip joint
• If there is a fracture of the joint in the image finding
• If researchers judge that it is inappropriate to participate in the study;
• If you do not agree to participate in the study;
• Minors

Sponsors & Collaborators

• Jaseng Medical Foundation: lead

Study Sites (1)

Jaseng Hospital of Korean Medicine

Seoul, Gangnam-Gu, 135-896, South Korea

Location

Related Publications (1)

• Lee JH, Song JY, Park KS, Lee J, Ha IH, Lee YJ. Long-term follow-up of inpatients with meniscus tears who received integrative Korean medicine treatment: A retrospective analysis and follow-up survey. Medicine (Baltimore). 2024 Feb 9;103(6):e36917. doi: 10.1097/MD.0000000000036917.

  PMID: 38335386 DERIVED

Study Officials

• In-Hyuk Ha, Ph.D

  Jaseng Medical Foundation

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 23, 2021
• First Posted: August 25, 2021
• Study Start: March 1, 2021
• Primary Completion: November 15, 2021
• Study Completion: December 30, 2021
• Last Updated: January 14, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)