NCT05177302

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2022

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2023

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

11 months

First QC Date

December 2, 2021

Last Update Submit

November 12, 2023

Conditions

Keywords

hip and/ or groin painreliabilityvalidityresponsivenessHAGOS

Outcome Measures

Primary Outcomes (4)

  • HAGOS-C

    The individuals will be asked to complete 37 items of the HAGOS-C after instruction

    immediately after the intervention

  • SF-36v2

    The individuals will be asked to complete 36 items of the SF-36v2 after instruction for validation

    immediately after the intervention

  • HAGOS-C

    The individuals will be asked to complete 37 items of the HAGOS-C after instruction for reliability.

    after 1 week

  • HAGOS-C

    The individuals will be asked to complete 37 items of the HAGOS-C after instruction for responsiveness

    after 4 months

Study Arms (1)

Individuals with hip and/ or groin pain

The young to middle-aged physically active individuals with hip and/ or groin pain, which symptoms lasting for 2 to 6 month.

Other: HAGOS-COther: SF-36v2

Interventions

HAGOS-COTHER

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

Individuals with hip and/ or groin pain
SF-36v2OTHER

The subjects will be instructed to complete SF-36v2 at the initial contact to determine the validity of HAGOS-C

Individuals with hip and/ or groin pain

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The individuals with long-standing hip and/ or groin pain lasting 2 to 6 month, which hip and/ or groin pain during motion with restriction or giving way sensation, or clicking sound in hip joint, and tenderness on iliopsoas, inguinal, hip adductors, pubic symphysis will be included . The individuals with other symptoms in lumbar, knee or ankle joint will be excluded.

You may qualify if:

  • 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.

You may not qualify if:

  • other symptoms in lumbar, knee or ankle joint.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Yang Ming University

Taipei, 11221, Taiwan

Location

Study Officials

  • Yi-Fen Shih, Ph.D

    Department of Physical Therapy and Assistive Technology, National Yang-Ming Chiao-Tung University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 2, 2021

First Posted

January 4, 2022

Study Start

March 1, 2022

Primary Completion

January 10, 2023

Study Completion

January 10, 2023

Last Updated

November 14, 2023

Record last verified: 2023-11

Locations