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

NCT03842098 | Unknown

• 1 other identifier: ISEE_2018_KPOP-MD
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Musculoskeletal Disorders; Korean Medicine Patient Registry; Post-operative Therapy

Keywords

Korean Medicine Patient Registry; Post-operative Therapy; Musculoskeletal Disorders

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (1)

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who suffers from various symptoms after musculoskeletal surgeries

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Gachon universiry affiliated Gil oriental medicine hospital

Incheon, South Korea

RECRUITING

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

• Yun-Kyung Song, PhD

  Gachon University Gil Oriental Medical Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Youme Ko, MA

CONTACT

8229619278; meyougo@khu.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: February 15, 2019
• Study Start: June 1, 2019
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: October 15, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)