Prevalence of Unknown and Known Diabetes in Patients With Frozen Shoulder

February 10, 2016 updated by: per hviid gundtoft, Sygehus Lillebaelt

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Kolding, Denmark, 6000
        • Sygehus Lillebaelt
      • Vejle, Denmark, 7100
        • Vejle Sygehus
    • Copenhagen
      • Amager, Copenhagen, Denmark, 2300
        • Amager Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All newly referred patients to one of the involved hospitals who is diagnosed with frozen shoulder.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patient with diabetes
Patients who have been diagnoses with diabetes.
Patients without diabetes
Patients who have not previous been diagnosed with diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
prevalence of known and unknown diabetes diabetes
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diabetes influence on the prognosis of frozen shoulder
Time Frame: 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.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sygehus Lillebaelt

Collaborators

Amager Hospital

Investigators

  • Principal Investigator: per h gundtoft, md, Sygehus Lillebaelt

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

October 26, 2013

First Submitted That Met QC Criteria

November 1, 2013

First Posted (Estimate)

November 8, 2013

Study Record Updates

Last Update Posted (Estimate)

February 11, 2016

Last Update Submitted That Met QC Criteria

February 10, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gundtoft-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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