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

• ClinicalTrials.gov Identifier: NCT04755049
• Recruitment Status: Enrolling by invitation
• First Posted: February 15, 2021
• Last Update Posted: February 15, 2021
• Sponsor: National Cheng-Kung University Hospital
• Information provided by (Responsible Party): Kai-Lan Hsu, National Cheng-Kung University Hospital

Study Description

Brief 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).

Condition or disease	Intervention/treatment
Shoulder Pain	Diagnostic Test: The Chinese version of the American Shoulder and Elbow Surgeons standardized shoulder assessment form questionnaire

Study Design

• Study Type: Observational
• Actual Enrollment: 86 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• 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
• Actual Study Start Date: March 1, 2020
• Actual Primary Completion Date: September 30, 2020
• Estimated Study Completion Date: December 1, 2021

Groups and Cohorts

Intervention Details:

• 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

Outcome Measures

Primary Outcome Measures :

1. The Chinese version of the American Shoulder and Elbow Surgeons standardized shoulder assessment form questionnaire [ Time Frame: The questionaire was completed at 7 days before the index surgery. ]
   American Shoulder and Elbow Surgeons (ASES) Assessment Form, ranging from 0-100. The higher score indicates better shoulder function.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

patients with any shoulder disorders

Criteria

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

Contacts and Locations

Locations

Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan, 70428

Sponsors and Collaborators

National Cheng-Kung University Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Tie TA, Hong CK, Chua I, Kuan FC, Su WR, Hsu KL. 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. BMC Musculoskelet Disord. 2021 Apr 24;22(1):382. doi: 10.1186/s12891-021-04255-z.

• Responsible Party: Kai-Lan Hsu, Attending physician, National Cheng-Kung University Hospital
• ClinicalTrials.gov Identifier: NCT04755049
• Other Study ID Numbers: A-ER-109-163
• First Posted: February 15, 2021
• Last Update Posted: February 15, 2021
• Last Verified: February 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Shoulder Pain; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations