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Korean Medicine Patient Registry of Postoperative Therapy for Musculoskeletal Disorders (KPOP-MD): A Study Protocol

Sponsor
Gachon University Gil Oriental Medical Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03842098
Collaborator
Kyunghee University Medical Center (Other), CHUNG YEON Korean Medicine Hospital (Other), Korean medicine hospital of Daejeon University (Other), Wonkwang University Iksan Korean Medicine Hospital (Other)
150
Enrollment
1
Location
36
Anticipated Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Korean Medicine Patient Registry of Postoperative Therapy for Musculoskeletal Disorders (KPOP-MD): A Study Protocol
    Actual Study Start Date :
    Jun 1, 2019
    Anticipated Primary Completion Date :
    May 31, 2022
    Anticipated Study Completion Date :
    May 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Change in musculoskeletal pain intensity [At baseline, enrollment after 3/6/9/12 months]

      Assessment of musculoskeletal pain intensity by Numeric Rating Scale (NRS)

    2. Change in Disability and estimating quality of life [At baseline, enrollment after 3/6/9/12 months]

      Disability and estimating quality of life by Oswestry Disability Index

    3. Change in reduction of pain severity by K-WOMAC [At baseline, enrollment after 3/6/9/12 months]

      Assessment of pain severity by K-WOMAC

    4. Change in Pain and disability of the shoulder by SPADI questionnaire [At baseline, enrollment after 3/6/9/12 months]

      Assessment of Pain and disability of the shoulder by SPADI questionnaire

    5. Change in current health status [At baseline, enrollment after 3/6/9/12 months]

      The health status will be observed with the Euroqol (EQ-5D-5L) questionnaire.

    6. Change in Severity assessment of any symptoms other than pain [At baseline, enrollment after 3/6/9/12 months]

      Severity assessment of any symptoms other than pain by Numeric Rating Scale (NRS)

    Eligibility Criteria

    Criteria

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

    • 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

    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gachon universiry affiliated Gil oriental medicine hospital Incheon Korea, Republic of

    Sponsors and Collaborators

    • Gachon University Gil Oriental Medical Hospital
    • Kyunghee University Medical Center
    • CHUNG YEON Korean Medicine Hospital
    • Korean medicine hospital of Daejeon University
    • Wonkwang University Iksan Korean Medicine Hospital

    Investigators

    • Principal Investigator: Yun-Kyung Song, PhD, Gachon University Gil Oriental Medical Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yun-Kyung Song, Principal Investigator, Gachon University Gil Oriental Medical Hospital
    ClinicalTrials.gov Identifier:
    NCT03842098
    Other Study ID Numbers:
    • ISEE_2018_KPOP-MD
    First Posted:
    Feb 15, 2019
    Last Update Posted:
    Oct 15, 2021
    Last Verified:
    Oct 1, 2021
    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
    Keywords provided by Yun-Kyung Song, Principal Investigator, Gachon University Gil Oriental Medical Hospital
    Korean Medicine Patient Registry
    Post-operative Therapy
    Musculoskeletal Disorders
    Additional relevant MeSH terms:
    Musculoskeletal Diseases
    Disease

    Study Results

    No Results Posted as of Oct 15, 2021