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

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

• Registration Number: NCT03842098
• Lead Sponsor: Gachon University Gil Oriental Medical Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-02-13
• Study First Posted: 2019-02-15
• Study Start: 2019-06-01
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-14
• Last Update Posted: 2021-10-15
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 musculoskeletal pain intensity	At baseline, enrollment after 3/6/9/12 months	Assessment of musculoskeletal pain intensity by Numeric Rating Scale (NRS)
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)

Trial Locations

Locations (1)

Gachon universiry affiliated Gil oriental medicine hospital; 🇰🇷 Incheon, Korea, Republic of