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Completed

NCT Number: NCT05020938

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

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.

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Key information

Conditions

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Jaseng Hospital of Korean Medicine

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

phone survey

Other

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

Primary outcomes

  1. Numeric Rating Scale (NRS)

    Time frame: 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 outcomes

  1. Western Ontario and McMasters Universities(WOMAC) Osteoarthritis Index

    Time frame: Finish survey by August 2021

    Knee Pain intensity scale

  2. EuroQol 5 Dimension (EQ 5D 5L)

    Time frame: Finish survey by August 2021

    5 Level Quality of life

  3. Patient Global Impression of Change (PGIC)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Jaseng Medical Foundation

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Aug 25, 2021
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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