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临床试验/NCT03842098
NCT03842098Unknown不适用

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

Gachon University Gil Oriental Medical Hospital1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年6月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
150
试验地点
1
主要终点
Change in Disability and estimating quality of life

研究概览

简要总结

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in Disability and estimating quality of life

时间窗: At baseline, enrollment after 3/6/9/12 months

Disability and estimating quality of life by Oswestry Disability Index

Change in musculoskeletal pain intensity

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: At baseline, enrollment after 3/6/9/12 months

Severity assessment of any symptoms other than pain by Numeric Rating Scale (NRS)

次要结局

未报告次要终点

研究者

发起方
Gachon University Gil Oriental Medical Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yun-Kyung Song

Principal Investigator

Gachon University Gil Oriental Medical Hospital

研究点 (1)

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