Diabetic Shoulder Mobility

Study Overview
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Brief Summary
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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.

Official Title
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Diabetic Upper Extremity Pathophysiology, Limited Joint Mobility and Disability

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Other: Optimized Shoulder Movement Program
* Other: ADA Guideline Instructed


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ADA guideline Instructed<br>The control intervention will be instruction in basic wellness activities according to the American Diabetes Association guidelines | Other: ADA Guideline Instructed<br>* The ADA guideline instructions are to include: blood sugar control (goal is A1c < 7.0%), physical activity (150 minutes/week of moderate intensity aerobic activity), foot care (examine feet daily, monofilament testing), and blood pressure control (goal is <130/80). Participants will receive a logbook to record daily outcomes. The goal of this intervention is to control for personal interactions with investigators and provide useful information for disease management but not provide intervention that likely would improve shoulder joint motion. The control group will be given instruction in the exercise program at the end of the 1 year study period.<br>|
| Experimental: Optimized Shoulder Movement Program<br>The experimental intervention is the Optimized Shoulder Movement Program. Participants will be trained in a progressive home exercise program that includes passive stretching of end range shoulder flexion and external rotation, and active shoulder motion based on the participant's baseline activity count . | Other: Optimized Shoulder Movement Program<br>* A trained physical therapist will see the participant for a max of 6 visits over the 3 month intervention; for baseline instruction, and at 2, 4, 6, and 8 weeks to progress and check subject adherence before a final check-out and testing visit at 3 months. Participants will perform 3 assigned stretching motions a min of 2 sets of 10 reps each and will be instructed in active shoulder movements with a dose based on the subject's measured activity count at baseline and with enough duration to increase it by 10%. Exercise: 10-15 minutes 2x/day for 3 month duration. Participants will log their activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arm elevation. | Arm elevation is a composite of shoulder (glenohumeral) and scapular motion and will be measured using goniometry and computer assisted kinematics. Glenohumeral elevation and external rotation motions are the main focus. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability of the Arm, Shoulder, and Hand (DASH) questionnaire | The DASH is an established, standardized measure used to characterize pain and disability in the upper extremity. | One year |