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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05164562
Other study ID # 2021-013-TMS-DT1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 7, 2022
Est. completion date January 1, 2023

Study information

Verified date March 2022
Source Université de Reims Champagne-Ardenne
Contact Brigitte DELEMER, MD
Phone 0326788101
Email bdelemer@chu-reims.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Osteopenia and osteoporosis, particularly related to insulinopenia, are common in type 1 diabetes and increase the risk of fractures. Musculoskeletal disorders of the upper limb are a common complication of type 1 diabetes. However, there is no official recommendation for screening for musculoskeletal disorders in France.


Description:

The aim of the study is to describe prevalence of musculoskeletal disorders of upper limb in type 1 diabetes patients.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date January 1, 2023
Est. primary completion date July 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - male or female - aged of 18 and more - with type 1 diabetes - agreeing to participate in the study Exclusion Criteria: - none

Study Design


Intervention

Other:
Data collection
Description: musculoskeletal disorders of upper limb evaluation

Locations

Country Name City State
France Centre Hospitalier Universitaire de Reims Reims Grand-Est

Sponsors (1)

Lead Sponsor Collaborator
Université de Reims Champagne-Ardenne

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary musculoskeletal disorders of upper limb musculoskeletal disorders of upper limb evaluated using Quick Dash (Quick Disabilities of Arm, Shoulder and Hand).
Quick Dash is a 11 items questionnaire that measures an individual's ability to complete tasks, absorb forces, and severity of symptoms. The QuickDASH tool uses a 5-point Likert scale from which the patient can select an appropriate number corresponding to his/her severity/function level. The score ranges from 0 (no disability) to 100 (most severe disability), a higher score indicates a greater level of disability and severity, whereas, lower score indicates a lower level of disability.
Day 0
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