Meniscus TearNCT05020938
Long Term Follow-Up of KNEE PAIN Patients Accompanying Meniscus Tear
An observational study of Meniscus Tear, run by Jaseng Medical Foundation at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Meniscus Tear
- What is being tested?
- phone survey
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Mar 2021to 30 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Jaseng Hospital of Korean Medicine
Seoul, Gangnam-Gu, 135-896
About this study
Official title: 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.
Read the 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.
- Conditions
- Meniscus Tear
- Being tested
- phone survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phone surveyOther
A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over the phone for patients.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Finish survey by August 2021
Secondary outcomes (3)
Western Ontario and McMasters Universities(WOMAC) Osteoarthritis Index
Knee Pain intensity scale
Measured: Finish survey by August 2021
EuroQol 5 Dimension (EQ 5D 5L)
5 Level Quality of life
Measured: 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)
Measured: Finish survey by August 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start1 Mar 2021
- Primary completion15 Nov 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Meniscus TearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jaseng Medical Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Hyuk Ha, KMD, Jaseng Medical Foundation
- Investigators
- In-Hyuk Ha, Ph.D, Study director, Jaseng Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020938
- Sponsor's protocol ID
- JS-CT-2021-12
- Status last verified
- Jan 2022
- First submitted
- 23 Aug 2021
- Last updated
- 14 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38335386
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-Up of KNEE PAIN Patients Accompanying Meniscus Tear Treated With Integrated Complementary and Alternative
- ClinicalTrials.gov ID
- NCT05020938
- Acronym / sponsor ID
- JS-CT-2021-12
- Conditions
- Meniscus Tear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Jaseng Medical FoundationUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Nov 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phone surveyA questionnaire about the current symptoms and satisfaction for received treatment will be conducted over the phone for patients. | Other | – |
Primary outcome
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.
3 secondary outcomes
Western Ontario and McMasters Universities(WOMAC) Osteoarthritis Index
Time frame: Finish survey by August 2021
EuroQol 5 Dimension (EQ 5D 5L)
Time frame: Finish survey by August 2021
Patient Global Impression of Change (PGIC)
Time frame: Finish survey by August 2021
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Derived from this study: PubMed 38335386Lee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
In-Hyuk Ha, Ph.D study director
Jaseng Medical Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Meniscus Tear, run by Jaseng Medical Foundation at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (NRS) (time frame: Finish survey by August 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05020938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2022.