Prevalence of Unknown and Known Diabetes in Patients With Frozen Shoulder

Diabetes Mellitus Clinical Trial

Official title:

Prevalence of Unknown and Known Diabetes in Patients With Frozen Shoulder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01978886
• Other study ID #: Gundtoft-01
• Status: Completed
• Phase: N/A
• First received: October 26, 2013
• Last updated: February 10, 2016
• Start date: December 2013
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Sygehus Lillebaelt
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 75 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bursitis
• Diabetes Mellitus
• Frozen Shoulder

Locations

Country	Name	City	State
Denmark	Amager Hospital	Amager	Copenhagen
Denmark	Sygehus Lillebaelt	Kolding
Denmark	Vejle Sygehus	Vejle

Sponsors (2)

Lead Sponsor	Collaborator
Sygehus Lillebaelt	Amager Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	prevalence of known and unknown diabetes diabetes		1 year	No
Secondary	diabetes influence on the prognosis of frozen shoulder	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.	24 months	No