- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03320356
Transcultural Validation of the Oxford Shoulder Score for the French-speaking Population (French-OSS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients receiving chemotherapy for solid tumors in Ambulatory Medicine Unit of the Reims University Hospital (France) between May 14, 2012 and July 31, 2013
- native French speakers
Exclusion Criteria:
- Patients who presented shoulder's instability problems
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
shoulder pain
Patients presenting inflammatory, degenerative, or post-traumatic shoulder pain and consulting at Orthopaedic Department, Reims Teaching Hospital.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptability of the French version of the Oxford Shoulder Score
Time Frame: Day 0
|
Acceptability was analysed using the rate of refusal to participate. It is a 12-item self-administered questionnaire developed for patients with inflammatory or degenerative shoulder disease. Each question presents five possible responses corresponding to a score of 0 (worst situation) to 4 (best situation). Questionnaire produces a single score with a range from 0 (least difficulties) to 48 (most difficulties). |
Day 0
|
Feasibility of the French version of the Oxford Shoulder Score
Time Frame: Day 0
|
Feasibility was analysed using the nonresponse rate. It is a 12-item self-administered questionnaire developed for patients with inflammatory or degenerative shoulder disease. Each question presents five possible responses corresponding to a score of 0 (worst situation) to 4 (best situation). Questionnaire produces a single score with a range from 0 (least difficulties) to 48 (most difficulties). |
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Convergent validity of the French version of the Oxford Shoulder Score
Time Frame: Day 0
|
The convergent validity was studied using correlation between the Oxford Shoulder Score and the Constant score and between the Oxford Shoulder Score and the Subjective Shoulder Score score.
|
Day 0
|
test/retest reliability of the French version of the Oxford Shoulder Score
Time Frame: Day 0
|
Test/retest reliability was analysed using calculation of the intraclass correlation coefficient.
An ICC > 0.8 indicates good test/retest reliability.
|
Day 0
|
Internal coherence of the French version of the Oxford Shoulder Score
Time Frame: Day 0
|
The internal coherence was tested using the Cronbach coefficient.
The acceptable threshold for internal coherence was a Cronbach coefficient equal or more than 0.7
|
Day 0
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016Ao001
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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