Musculoskeletal DisordersNCT03842098
Korean Medicine Patient Registry of Postoperative Therapy for Musculoskeletal Disorders (KPOP-MD): A Study Protocol
An observational study of Musculoskeletal Disorders and Korean Medicine Patient Registry, run by Gachon University Gil Oriental Medical Hospital at 1 site in South Korea.
Trial summary
To create an infrastructure that allows for the conduct of prospective, controlled studies comparing the effectiveness of diagnostic and treatment strategies for patients with musculoskeletal disorders after musculoskeletal operations Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Musculoskeletal Disorders, Korean Medicine Patient Registry, Post-operative Therapy
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2019to 31 May 2022
- 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: patients who suffers from various symptoms after musculoskeletal surgeries
Who may be able to join
- aged 19 and over
- Those who have undergone musculoskeletal related surgery (corresponding to the disease classification code M00-99, S00-99) within 3 years
- voluntary applicant who has no problem with communicate with study associates or a mild cognitive impairment patient who scored higher than 23 points in Korean version of the montreal rating questionnaire with voluntary participation
Who cannot join
- Participants in other clinical trials
- Those who are unlikely to be adhered to the schedule of clinical studies
- Those who are expected to have difficulty understanding and responding to research questionnaires such as illiteracy, mental and physical weakness
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Gachon universiry affiliated Gil oriental medicine hospital
Incheon
Gangmin Lee, MA
About this study
To create an infrastructure that allows for the conduct of prospective, controlled studies comparing the effectiveness of diagnostic and treatment strategies for patients with musculoskeletal disorders after musculoskeletal operations
- Keywords
- Korean Medicine Patient Registry, Post-operative Therapy, Musculoskeletal Disorders
- Medical subject headings
- Musculoskeletal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Musculoskeletal Disorders patients | Enroll the post operative musculoskeletal disorders patients and follow up their clinic visits and treatment regimen to analyze their utility in healthcare |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in musculoskeletal pain intensity
Assessment of musculoskeletal pain intensity by Numeric Rating Scale (NRS)
Measured: At baseline, enrollment after 3/6/9/12 months
Change in Disability and estimating quality of life
Disability and estimating quality of life by Oswestry Disability Index
Measured: At baseline, enrollment after 3/6/9/12 months
Change in reduction of pain severity by K-WOMAC
Assessment of pain severity by K-WOMAC
Measured: At baseline, enrollment after 3/6/9/12 months
Change in Pain and disability of the shoulder by SPADI questionnaire
Assessment of Pain and disability of the shoulder by SPADI questionnaire
Measured: At baseline, enrollment after 3/6/9/12 months
Change in current health status
The health status will be observed with the Euroqol (EQ-5D-5L) questionnaire.
Measured: At baseline, enrollment after 3/6/9/12 months
Change in Severity assessment of any symptoms other than pain
Severity assessment of any symptoms other than pain by Numeric Rating Scale (NRS)
Measured: At baseline, enrollment after 3/6/9/12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Jun 2019
- Primary completion31 May 2022 (estimated)
- Study completion31 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Musculoskeletal DisordersStudies 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
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gachon University Gil Oriental Medical Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kyunghee University Medical Center, CHUNG YEON Korean Medicine Hospital, Korean medicine hospital of Daejeon University, Wonkwang University
- Responsible party
- Principal investigator, Yun-Kyung Song, Gachon University Gil Oriental Medical Hospital
- Investigators
- Yun-Kyung Song, PhD, Principal investigator, Gachon University Gil Oriental Medical Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03842098
- Sponsor's protocol ID
- ISEE_2018_KPOP-MD
- Status last verified
- Oct 2021
- First submitted
- 13 Feb 2019
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: denial from study associates
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korean Medicine Patient Registry of Postoperative Therapy for Musculoskeletal Disorders (KPOP-MD): A Study Protocol
- ClinicalTrials.gov ID
- NCT03842098
- Acronym / sponsor ID
- ISEE_2018_KPOP-MD
- Keywords
- Korean Medicine Patient Registry, Post-operative Therapy, Musculoskeletal Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Gachon University Gil Oriental Medical HospitalUniversity, hospital or other
- Collaborators
- Kyunghee University Medical Center, CHUNG YEON Korean Medicine Hospital, Korean medicine hospital of Daejeon University, Wonkwang University
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 31 May 2022 (estimated)
- First posted
- 15 Feb 2019 (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.
To create an infrastructure that allows for the conduct of prospective, controlled studies comparing the effectiveness of diagnostic and treatment strategies for patients with musculoskeletal disorders after musculoskeletal operations
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Musculoskeletal Disorders patients | – | –Enroll the post operative musculoskeletal disorders patients and follow up their clinic visits and treatment regimen to analyze their utility in healthcare |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who suffers from various symptoms after musculoskeletal surgeries
Key inclusion criteria (3 listed)
- aged 19 and over
- Those who have undergone musculoskeletal related surgery (corresponding to the disease classification code M00-99, S00-99) within 3 years
- voluntary applicant who has no problem with communicate with study associates or a mild cognitive impairment patient who scored higher than 23 points in Korean version of the montreal rating questionnaire with voluntary participation
Key exclusion criteria (3 listed)
- Participants in other clinical trials
- Those who are unlikely to be adhered to the schedule of clinical studies
- Those who are expected to have difficulty understanding and responding to research questionnaires such as illiteracy, mental and physical weakness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in musculoskeletal pain intensity
Time frame: At baseline, enrollment after 3/6/9/12 months
Assessment of musculoskeletal pain intensity by Numeric Rating Scale (NRS)
Change in Disability and estimating quality of life
Time frame: At baseline, enrollment after 3/6/9/12 months
Disability and estimating quality of life by Oswestry Disability Index
Change in reduction of pain severity by K-WOMAC
Time frame: At baseline, enrollment after 3/6/9/12 months
Assessment of pain severity by K-WOMAC
Change in Pain and disability of the shoulder by SPADI questionnaire
Time frame: At baseline, enrollment after 3/6/9/12 months
Assessment of Pain and disability of the shoulder by SPADI questionnaire
Change in current health status
Time frame: At baseline, enrollment after 3/6/9/12 months
The health status will be observed with the Euroqol (EQ-5D-5L) questionnaire.
Change in Severity assessment of any symptoms other than pain
Time frame: At baseline, enrollment after 3/6/9/12 months
Severity assessment of any symptoms other than pain by Numeric Rating Scale (NRS)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- Individual participant dataSharing planned: No. denial from study associates
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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.
Yun-Kyung Song, PhD principal investigator
Gachon University Gil Oriental Medical Hospital
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 Musculoskeletal Disorders and Korean Medicine Patient Registry, run by Gachon University Gil Oriental Medical Hospital 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 3 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: status not confirmed, as of the sponsor's last update on 15 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youme Ko, MA (8229619278, meyougo@khu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in musculoskeletal pain intensity (time frame: At baseline, enrollment after 3/6/9/12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2021.