The Chinese Version of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form Questionnaire, Patient Self-report Section: A Cross-cultural Adaptation and Validation Study

Shoulder Pain Clinical Trial

Official title:

The Chinese Version of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form Questionnaire, Patient Self-report Section: A Cross-cultural Adaptation and Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04755049
• Other study ID #: A-ER-109-163
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: December 1, 2021

Study information

• Verified date: September 2022
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background: The patient self-report section of the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASESp) is one of the most validated and reliable assessment tools. This study aimed to establish a validated Chinese version of ASESp (ASESp-CH).

Methods: A clinical prospective study was performed. Following the guidelines of forward-backward translation and cross-cultural adaptation, a Chinese version of ASESp was established. Patients older than 18 years with shoulder disorders were included. Patients who could not complete test-retest questionnaires within the interval of 7-30 days and patients who received interventions were excluded. Intraclass correlation (ICC) was calculated for test- retest reliability, whereas internal consistency was determined by Cronbach value. Construct validity was evaluated by comparing the corresponding domains between the ASESp-CH and a validated Chinese version of 36-Item Short Form Health Survey (SF-36).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 1, 2021
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• [1] patients' age = 18 years

• [2] patients with clear insights

• [3] patients with any shoulder disorders

• [4] patients who are able to speak and write in Chinese

• [5] patients who completed the questionnaires twice at an interval of 7 days to 30 days.

Exclusion Criteria:

• [1] the patient could not complete all of ASESp-CH and SF-36 questionnaires

• [2] the test-retest interval was less than 7 days or more than 30 days

• [3] the patient received interventional procedures, such as shoulder injections or surgery, during the test-retest interval

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Diagnostic Test:
• The Chinese version of the American Shoulder and Elbow Surgeons standardized shoulder assessment form questionnaire
The Chinese version of the American Shoulder and Elbow Surgeons standardized shoulder assessment form questionnaire

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Chinese version of the American Shoulder and Elbow Surgeons standardized shoulder assessment form questionnaire	American Shoulder and Elbow Surgeons (ASES) Assessment Form, ranging from 0-100. The higher score indicates better shoulder function.	The questionaire was completed at 7 days before the index surgery.