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

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 Overview

• Status: Recruiting
• Conditions: Musculoskeletal Disorders; Korean Medicine Patient Registry; Post-operative Therapy

• Study Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

• Study Contact: Name: Youme Ko, MA; Phone Number: 8229619278; Email: meyougo@khu.ac.kr

Study Locations

• Korea, Republic of
  • Incheon, Korea, Republic of
    • Recruiting
    • Gachon universiry affiliated Gil oriental medicine hospital
    • Contact: Gangmin Lee, MA

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients who suffers from various symptoms after musculoskeletal surgeries

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in musculoskeletal pain intensity	Assessment of musculoskeletal pain intensity by Numeric Rating Scale (NRS)	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	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	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	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.	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)	At baseline, enrollment after 3/6/9/12 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ANTICIPATED): May 31, 2022
• Study Completion (ANTICIPATED): May 31, 2022

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: February 13, 2019
• First Posted (ACTUAL): February 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): October 15, 2021
• Last Update Submitted That Met QC Criteria: October 14, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Musculoskeletal Disorders; Korean Medicine Patient Registry; Post-operative Therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Musculoskeletal Diseases
• Other Study ID Numbers: ISEE_2018_KPOP-MD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: denial from study associates

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No