Prevalence of Unknown and Known Diabetes in Patients With Frozen Shoulder

Completed

• Conditions: Frozen Shoulder; Diabetes Mellitus

• Registration Number: NCT01978886
• Lead Sponsor: Sygehus Lillebaelt

Brief Summary

The purpose of the study is to investigate how high the prevalence of diabetes (known and unknown) is among patients with a frozen shoulder. Our hypothesis is that it is around 30-40 %.

Another purpose is to investigate whether patients with diabetes have a worse and more painful frozen shoulder than patients without diabetes, and whether the diabetes have an influence on the prognosis.

Detailed Description

Patients who are not diagnosed with diabetes would be ask to give a blood sample to investigate if they have an unknown diabetes.

All patients with frozen shoulder will be asked to fill out a questionnaire (Oxford Shoulder Score) to clarify how bad their frozen shoulder is. All patients will receive the questionnaire 6 and 24 month following the date on inclusion.

Study Timeline

• Study First Submitted: 2013-10-26
• Study First Submitted QC: 2013-11-01
• Study First Posted: 2013-11-08
• Study Start: 2013-12
• Status Verified: 2016-02
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-02-10
• Last Update Posted: 2016-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

All newly referred patients who is being diagnosed with frozen shoulder -

Exclusion Criteria

age below 25 or above 75, pt. who don't read or understand danish, not danish citizen, patients with mental illness, pt. with a abuse of alcohol or substances, pregnancy, pt. who within 4 months have been injected with adrenocortical hormone, arthrosis in the glenohumeral joint, avascular necrosis of caput humeri, rotator cuff lesion.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
prevalence of known and unknown diabetes diabetes	1 year

Secondary Outcome Measures

Name	Time	Method
diabetes influence on the prognosis of frozen shoulder	24 months	how the status of diabetes influence the prognosis of frozen shoulder. The patient will be asked to fill out oxford shoulder score at the time of inclusion and at 6 and 24 months follow-up. The two groups (patients with and without diabetes) will be compared using the oxford shoulder score.

Trial Locations

Locations (3)

Amager Hospital; 🇩🇰 Amager, Copenhagen, Denmark

Sygehus Lillebaelt; 🇩🇰 Kolding, Denmark

Vejle Sygehus; 🇩🇰 Vejle, Denmark