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Trial record 11 of 51 for:    "Frozen Shoulder"

Prevalence of Unknown and Known Diabetes in Patients With Frozen Shoulder

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ClinicalTrials.gov Identifier: NCT01978886
Recruitment Status : Completed
First Posted : November 8, 2013
Last Update Posted : February 11, 2016
Sponsor:
Collaborator:
Amager Hospital
Information provided by (Responsible Party):
per hviid gundtoft, 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.


Condition or disease
Diabetes Mellitus Frozen Shoulder

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.


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Study Type : Observational [Patient Registry]
Actual Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 2 Years
Official Title: Prevalence of Unknown and Known Diabetes in Patients With Frozen Shoulder
Study Start Date : December 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

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



Primary Outcome Measures :
  1. prevalence of known and unknown diabetes diabetes [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
whole blood for patients not diagnosed with diabetes.


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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All newly referred patients to one of the involved hospitals who is diagnosed with frozen shoulder.
Criteria

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.

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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01978886


Locations
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Denmark
Amager Hospital
Amager, Copenhagen, Denmark, 2300
Sygehus Lillebaelt
Kolding, Denmark, 6000
Vejle Sygehus
Vejle, Denmark, 7100
Sponsors and Collaborators
Sygehus Lillebaelt
Amager Hospital
Investigators
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Principal Investigator: per h gundtoft, md Sygehus Lillebaelt

Additional Information:

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Responsible Party: per hviid gundtoft, MD, Ph.D.-student, Sygehus Lillebaelt
ClinicalTrials.gov Identifier: NCT01978886     History of Changes
Other Study ID Numbers: Gundtoft-01
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: February 11, 2016
Last Verified: February 2016

Keywords provided by per hviid gundtoft, Sygehus Lillebaelt:
Diabetes Mellitus
frozen shoulder
adhesive capsulitis

Additional relevant MeSH terms:
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Diabetes Mellitus
Bursitis
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Joint Diseases
Musculoskeletal Diseases