NCT03320356

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
144

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2014

Shorter than P25 for all trials

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

November 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 17, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
Last Updated

November 17, 2017

Status Verified

November 1, 2017

Enrollment Period

4 months

First QC Date

October 17, 2017

Last Update Submit

November 16, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (3)

  • Convergent validity of the French version of the Oxford Shoulder Score

    Day 0

  • test/retest reliability of the French version of the Oxford Shoulder Score

    Day 0

  • Internal coherence of the French version of the Oxford Shoulder Score

    Day 0

Study Arms (1)

shoulder pain

Patients presenting inflammatory, degenerative, or post-traumatic shoulder pain and consulting at Orthopaedic Department, Reims Teaching Hospital.

Other: the French version of the Oxford Shoulder Score

Interventions

Eligibility Criteria

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

All patients presenting inflammatory, degenerative, or post-traumatic shoulder pain and consulting at Orthopaedic Department, Reims Teaching Hospital (France) between November, 2014 and March, 2015.

You may qualify if:

  • 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

You may not qualify if:

  • Patients who presented shoulder's instability problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Tuton D, Barbe C, Salmon JH, Drame M, Nerot 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.

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
SPONSOR

Study Record Dates

First Submitted

October 17, 2017

First Posted

October 25, 2017

Study Start

November 1, 2014

Primary Completion

March 1, 2015

Study Completion

July 1, 2015

Last Updated

November 17, 2017

Record last verified: 2017-11