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

Sponsor
Jaseng Medical Foundation (Other)
Overall Status
Completed
CT.gov ID
NCT05020938
Collaborator
(none)
86
Enrollment
1
Location
10
Actual Duration (Months)
8.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
86 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Long Term Follow-Up of KNEE PAIN Patients Accompanying Meniscus Tear Treated With Integrated Complementary and Alternative
Actual Study Start Date :
Mar 1, 2021
Actual Primary Completion Date :
Nov 15, 2021
Actual Study Completion Date :
Dec 30, 2021

Outcome Measures

Primary Outcome Measures

  1. Numeric Rating Scale (NRS) [Finish survey by August 2021]

    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.

Secondary Outcome Measures

  1. Western Ontario and McMasters Universities(WOMAC) Osteoarthritis Index [Finish survey by August 2021]

    Knee Pain intensity scale

  2. EuroQol 5 Dimension (EQ 5D 5L) [Finish survey by August 2021]

    5 Level Quality of life

  3. Patient Global Impression of Change (PGIC) [Finish survey by August 2021]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Jaseng Hospital of Korean Medicine Seoul Gangnam-Gu Korea, Republic of 135-896

Sponsors and Collaborators

  • Jaseng Medical Foundation

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
In-Hyuk Ha, KMD, Director, Jaseng Medical Foundation
ClinicalTrials.gov Identifier:
NCT05020938
Other Study ID Numbers:
  • JS-CT-2021-12
First Posted:
Aug 25, 2021
Last Update Posted:
Jan 14, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 14, 2022