Diabetic Shoulder Mobility
This trial is active, not recruiting.
|Treatments||optimized shoulder movement program, ada guideline instructed|
|Sponsor||Washington University School of Medicine|
|Start date||September 2014|
|End date||December 2016|
|Trial size||52 participants|
|Trial identifier||NCT02162212, 2014_DM_LJM, US NIH Grant R21 DK100793-01A1|
The primary goal of this project is to determine how advanced glycation end-product (AGEs) accumulation and shoulder movement (humeral thoracic range of motion and "activity count") interact to contribute to shoulder limited joint mobility (LJM), pain and disability, and if an intervention consisting of a tailored dose of stretching and active shoulder movement can reduce these problems in people with diabetes mellitus (DM). The investigators will focus on the following measures that span health domains; Skin intrinsic fluorescence to measure AGEs; Ultrasound to measure supraspinatus tendon thickness; 3 dimensional joint range of motion and "activity counts" to measure shoulder movements; and the Disability of the Arm, Shoulder and Hand (DASH) questionnaire to measure patient reported pain and disability. The investigators will test the innovative hypothesis that metabolic and movement factors interact to cause severe shoulder problems in people with DM and that an optimized shoulder movement intervention can have an important impact on reducing the development of limited joint mobility, pain and disability in this population.
|Intervention model||parallel assignment|
|Masking||single blind (outcomes assessor)|
time frame: One year
Disability of the Arm, Shoulder, and Hand (DASH) questionnaire
time frame: One year
Male or female participants from 40 years up to 70 years old.
Inclusion Criteria: - individuals with type 2 DM and duration of diagnosed diabetes more than 10 years OR type 2 DM and presence of a 'positive prayer sign' OR shoulder flexion < 150 degrees; disability of arm, shoulder and hand (DASH) scores in the range of <70%; between the age of 40-70 will be recruited. Exclusion Criteria: - currently diagnosed adhesive capsulitis - diagnosed rotator cuff tear - recent (6 months) upper extremity injury and/or fractures - surgery in the upper extremity or thorax - cervical radiculopathy - thoracic outlet syndrome - stroke with residual upper extremity involvement - severe skin allergies in area to be tested - rheumatic conditions - known connective tissue diseases - carpal tunnel syndrome - use of a cane - individuals who engage in heavy upper extremity/ overhead use (ie, painters, tennis players) because they likely have a different mechanism of injury than those with low shoulder activity.
|Official title||Diabetic Upper Extremity Pathophysiology, Limited Joint Mobility and Disability|
|Principal investigator||Michael J Mueller, PT, PHD|
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