Clinical trial NCT02162212: Diabetic Shoulder Mobility
Official title: Diabetic Upper Extremity Pathophysiology, Limited Joint Mobility and Disability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2014-06-12
Enrollment: 52
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Arm elevation.
timeFrame: One year
Secondary outcomes:
measure: Disability of the Arm, Shoulder, and Hand (DASH) questionnaire
timeFrame: One year
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Michael J Mueller, PT, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mueller MJ, Sorensen CJ, McGill JB, Clark BR, Lang CE, Chen L, Bohnert KL, Hastings MK. Effect of a Shoulder Movement Intervention on Joint Mobility, Pain, and Disability in People With Diabetes: A Randomized Controlled Trial. Phys Ther. 2018 Sep 1;98(9):745-753. doi: 10.1093/ptj/pzy070.