Transcultural Validation of the Oxford Shoulder Score for the French-speaking Population

Shoulder Pain Clinical Trial

— French-OSS  

Official title:

Transcultural Validation of the Oxford Shoulder Score for the French-speaking Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03320356
• Other study ID #: 2016Ao001
• Status: Completed
• Phase: N/A
• First received: October 17, 2017
• Last updated: November 16, 2017
• Start date: November 2014
• Est. completion date: July 2015

Study information

• Verified date: November 2017
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Degenerative lesions of the shoulder occur very frequently and their incidence increases with age. The Constant-Murley score is currently considered the gold standard in Europe to assess the shoulder and is widely used by the orthopaedic community to follow up on shoulder pathologies. However, healthcare professionals are taking an increasing interest in self-administered patient-reported out-come measures. Several self-administered questionnaires are available to assess the shoulder. Among these questionnaires, the OSS (Oxford Shoulder Score) is considered to be quick, simple, and reliable for the English-speaking population. This score was initially developed at the University of Oxford in 1996. It is a self-administered questionnaire designed to evaluate pain and shoulder function through 12 questions. This score has since been adapted in different languages but not in French.

Description:

The aim was to develop a translation and a transcultural adaptation of the OSS and to assess its validity in native French-speaker patients with shoulder pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: July 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Other:
• the French version of the Oxford Shoulder Score

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

References & Publications (1)

Tuton D, Barbe C, Salmon JH, Dramé M, Nérot C, Ohl X. Transcultural validation of the Oxford Shoulder Score for the French-speaking population. Orthop Traumatol Surg Res. 2016 Sep;102(5):555-8. doi: 10.1016/j.otsr.2016.05.010. Epub 2016 Jul 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acceptability of the French version of the Oxford Shoulder Score	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
Primary	Feasibility of the French version of the Oxford Shoulder Score	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	Convergent validity of the French version of the Oxford Shoulder Score	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
Secondary	test/retest reliability of the French version of the Oxford Shoulder Score	Test/retest reliability was analysed using calculation of the intraclass correlation coefficient. An ICC > 0.8 indicates good test/retest reliability.	Day 0
Secondary	Internal coherence of the French version of the Oxford Shoulder Score	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