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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03842098
Other study ID # ISEE_2018_KPOP-MD
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2019
Est. completion date May 31, 2022

Study information

Verified date October 2021
Source Gachon University Gil Oriental Medical Hospital
Contact Youme Ko, MA
Phone 8229619278
Email meyougo@khu.ac.kr
Is FDA regulated No
Health authority
Study type Observational

Clinical 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


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date May 31, 2022
Est. primary completion date May 31, 2022
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility 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 Design


Locations

Country Name City State
Korea, Republic of Gachon universiry affiliated Gil oriental medicine hospital Incheon

Sponsors (5)

Lead Sponsor Collaborator
Gachon University Gil Oriental Medical Hospital CHUNG YEON Korean Medicine Hospital, Korean medicine hospital of Daejeon University, Kyunghee University Medical Center, Wonkwang University Iksan Korean Medicine Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in musculoskeletal pain intensity Assessment of musculoskeletal pain intensity by Numeric Rating Scale (NRS) At baseline, enrollment after 3/6/9/12 months
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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