Overview

This trial is active, not recruiting.

Condition diabetes mellitus
Treatments optimized shoulder movement program, ada guideline instructed
Phase phase 1
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

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
The control intervention will be instruction in basic wellness activities according to the American Diabetes Association guidelines
ada guideline instructed
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.
(Experimental)
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" .
optimized shoulder movement program
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.

Primary Outcomes

Measure
Arm elevation.
time frame: One year

Secondary Outcomes

Measure
Disability of the Arm, Shoulder, and Hand (DASH) questionnaire
time frame: One year

Eligibility Criteria

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.

Additional Information

Official title Diabetic Upper Extremity Pathophysiology, Limited Joint Mobility and Disability
Principal investigator Michael J Mueller, PT, PHD
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Washington University School of Medicine.