Shoulder PainFrench-OSSNCT03320356
Transcultural Validation of the Oxford Shoulder Score for the French-speaking Population
An observational study of Shoulder Pain, run by CHU de Reims.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- the French version of the Oxford Shoulder Score
- How many people
- 144 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients who presented shoulder's instability problems
About this study
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.
Read the detailed 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.
- Conditions
- Shoulder Pain
- Being tested
- the French version of the Oxford Shoulder Score
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the French version of the Oxford Shoulder ScoreOther
| Study group | Role | What they receive |
|---|---|---|
| shoulder pain | Patients presenting inflammatory, degenerative, or post-traumatic shoulder pain and consulting at Orthopaedic Department, Reims Teaching Hospital. Receives: Other: the French version of the Oxford Shoulder Score |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Day 0
Secondary outcomes (3)
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.
Measured: Day 0
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.
Measured: Day 0
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
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study startNov 2014
- Primary completionMar 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320356
- Sponsor's protocol ID
- 2016Ao001
- Acronym
- French-OSS
- Status last verified
- Nov 2017
- First submitted
- 17 Oct 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 27460650
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcultural Validation of the Oxford Shoulder Score for the French-speaking Population
- ClinicalTrials.gov ID
- NCT03320356
- Acronym / sponsor ID
- French-OSS / 2016Ao001
- Conditions
- Shoulder Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- Mar 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 25 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| shoulder pain | – | Other: the French version of the Oxford Shoulder ScorePatients presenting inflammatory, degenerative, or post-traumatic shoulder pain and consulting at Orthopaedic Department, Reims Teaching Hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Patients who presented shoulder's instability problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the French version of the Oxford Shoulder Score | Other | shoulder pain |
Primary outcome
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).
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).
3 secondary outcomes
Convergent validity of the French version of the Oxford Shoulder Score
Time frame: Day 0
test/retest reliability of the French version of the Oxford Shoulder Score
Time frame: Day 0
Internal coherence of the French version of the Oxford Shoulder Score
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Results publication: PubMed 27460650Tuton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Pain, run by CHU de Reims.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the French version of the Oxford Shoulder Score (time frame: Day 0). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03320356, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.