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CompletedNCT04755049Updated Sep 29, 2022

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

An observational study in Shoulder Pain, sponsored by National Cheng-Kung University Hospital. Completed at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-29.

Sponsored by National Cheng-Kung University Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
120
Ages
18 Years and older
Sex
All
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Study 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).

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Conditions studied

  • Shoulder Pain

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In context

Shoulder Pain

707 studies on the registry are indexed under Shoulder Pain; 152 are open to participants now.

This study's enrollment of 120 is above the median of 82 across 130 observational studies indexed under Shoulder Pain.

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Lead sponsor

National Cheng-Kung University Hospital is the lead sponsor of 268 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients with any shoulder disorders

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

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
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
120 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testThe 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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: The questionaire was completed at 7 days before the index surgery.

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Study locations

1 site
  • National Cheng Kung University Hospital
    Tainan, 70428, Taiwan
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References and documents

Publications

  • 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. PubMed 33894753 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04755049
Lead sponsor
National Cheng-Kung University Hospital
Responsible party
Kai-Lan Hsu (Attending physician, National Cheng-Kung University Hospital) — Principal investigator
First posted
Feb 15, 2021
Start date
Mar 1, 2020
Primary completion
Sep 30, 2020
Completion
Dec 1, 2021
Last update
Sep 29, 2022

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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