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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05177302
Other study ID # YM110027E(3)
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 1, 2022
Est. completion date January 10, 2023

Study information

Verified date November 2023
Source National Yang Ming University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Hip and groin pain is a common injury in athletes participating multidirectional sports, and resulting in decreased sports participation and quality of life. The Copenhagen Hip And Groin Outcome Score (HAGOS) specifically targets young to middle-aged physically active individuals with long-standing hip and/ or groin pain, it consists of six separate subscales about symptoms, pain, physical function in daily living, physical function in sports and recreation, participation in physical activities and hip and/ or groin related quality of life (QoL), which all subscales have shown to have adequate validity, reliability and responsiveness in the original version of the questionnaire. Lacking of the specifical questionnaire for physically active people with hip and/or groin pain, the purpose of the study is to translate and cross-culturally adapt HAGOS into Chinese version (HAGOS-C) according to the guidelines from Beaton et al.


Description:

Hip and groin pain is a common injury in athletes participating multidirectional sports, and resulting in decreased sports participation and quality of life. The Copenhagen Hip And Groin Outcome Score (HAGOS) specifically targets young to middle-aged physically active individuals with long-standing hip and/ or groin pain, it consists of six separate subscales about symptoms, pain, physical function in daily living, physical function in sports and recreation, participation in physical activities and hip and/ or groin related quality of life (QoL), which all subscales have shown to have adequate validity, reliability and responsiveness in the original version of the questionnaire. Lacking of the specifical questionnaire for physically active people with hip and/or groin pain, the purpose of the study is to translate and cross-culturally adapt HAGOS into Chinese version (HAGOS-C) according to the guidelines from Beaton et al. We translated the questionnaire from the English version involved following steps: (1)initial translation with two bilingual translators (2) holding consensus meeting for the preliminary Chinese version (3) back translation with other two bilingual back translators (4) another consensus meeting for ensuring the consistency with original English version (5) pretesting for wording and understanding (6) Wording, rephrasing and format corrected to obtain final Chinese version of the HAGOS. The aim of the study is to determine the validity, reliability and responsiveness of HAGOS-C by recruiting young to middle-aged physically active individuals with long-standing hip and/ or groin pain.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date January 10, 2023
Est. primary completion date January 10, 2023
Accepts healthy volunteers No
Gender All
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria: - physically active at least 2.5 hrs/week - tenderness on iliopsoas, inguinal, hip adductors, pubic symphysis - hip and/ or groin pain during motion with restriction or giving way sensation, or clicking sound in hip joint. - pain lasting for 2 to 6 month and no obvious changes within 3 week recently. Exclusion Criteria: - other symptoms in lumbar, knee or ankle joint.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
HAGOS-C
The subjects will be instructed to complete HAGOS-C at the initial contact and again after 1 week and 4 month for reliability and responsiveness test, respectively
SF-36v2
The subjects will be instructed to complete SF-36v2 at the initial contact to determine the validity of HAGOS-C

Locations

Country Name City State
Taiwan National Yang Ming University Taipei

Sponsors (1)

Lead Sponsor Collaborator
National Yang Ming University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary HAGOS-C The individuals will be asked to complete 37 items of the HAGOS-C after instruction immediately after the intervention
Primary SF-36v2 The individuals will be asked to complete 36 items of the SF-36v2 after instruction for validation immediately after the intervention
Primary HAGOS-C The individuals will be asked to complete 37 items of the HAGOS-C after instruction for reliability. after 1 week
Primary HAGOS-C The individuals will be asked to complete 37 items of the HAGOS-C after instruction for responsiveness after 4 months
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