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Diabetic Shoulder Mobility

Diabetic Upper Extremity Pathophysiology, Limited Joint Mobility and Disability

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02162212
Enrollment
52
Registered
2014-06-12
Start date
2014-09-30
Completion date
2016-10-12
Last updated
2017-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Brief 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.

Interventions

OTHEROptimized 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.

OTHERADA 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.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Arm elevation.One yearArm 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.

Secondary

MeasureTime frameDescription
Disability of the Arm, Shoulder, and Hand (DASH) questionnaireOne yearThe DASH is an established, standardized measure used to characterize pain and disability in the upper extremity.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026