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Completed

NCT Number: NCT03320356

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

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.

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Key information

Conditions

Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

the French version of the Oxford Shoulder Score

Other

Primary outcomes

  1. 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).

  2. 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).

Secondary outcomes

  1. 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.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

CHU de Reims

Other

Registry information

Acronym: French-OSS

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Oct 25, 2017
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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