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

NCT03842098 — Unknown, 150 participants, Gachon University Gil Oriental Medical Hospital

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Registry	NCT03842098
Status	Unknown
Study type	Observational
Enrollment	150 (Estimated)
Sponsor	Gachon University Gil Oriental Medical Hospital (Other); collaborators: Kyunghee University Medical Center, CHUNG YEON Korean Medicine Hospital, Korean medicine hospital of Daejeon University, Wonkwang University
Conditions	Musculoskeletal Disorders, Korean Medicine Patient Registry, Post-operative Therapy
Dates	start 2019-06-01, primary completion 2022-05-31 (estimated), completion 2022-05-31 (estimated), first posted 2019-02-15, last updated 2021-10-15
Locations	1 site in South Korea

-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

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+Arms and interventions

Arm	Type	Interventions	Description
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 outcomes

Change in musculoskeletal pain intensity [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 [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 [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 [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 [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 [At baseline, enrollment after 3/6/9/12 months]: Severity assessment of any symptoms other than pain by Numeric Rating Scale (NRS)

+Eligibility

Sex: All, ages: 19 Years to any

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

+Locations (1)

Facility	City	Country	Status
Gachon universiry affiliated Gil oriental medicine hospital	Incheon	South Korea	Recruiting

+Investigators

Yun-Kyung Song, PhD, Principal investigator, Gachon University Gil Oriental Medical Hospital