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

Musculoskeletal Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03842098
• Other study ID #: ISEE_2018_KPOP-MD
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Disease
• Korean Medicine Patient Registry
• Musculoskeletal Diseases
• Musculoskeletal Disorders
• Post-operative Therapy

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