NCT04755049

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2020

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

Study Start

First participant enrolled

March 1, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

September 29, 2022

Status Verified

September 1, 2022

Enrollment Period

7 months

First QC Date

February 6, 2021

Last Update Submit

September 28, 2022

Conditions

Outcome Measures

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.

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

Interventions

The Chinese version of the American Shoulder and Elbow Surgeons standardized shoulder assessment form questionnaire

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with any shoulder disorders

You may qualify if:

  • \[1\] 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.

You may not qualify if:

  • \[1\] 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 70428, Taiwan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

February 6, 2021

First Posted

February 15, 2021

Study Start

March 1, 2020

Primary Completion

September 30, 2020

Study Completion

December 1, 2021

Last Updated

September 29, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations