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Diabetic Shoulder Mobility

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The Washington University

Status

Completed

Conditions

Diabetes Mellitus

Treatments

Other: Optimized Shoulder Movement Program
Other: ADA Guideline Instructed

Study type

Interventional

Funder types

Other

Identifiers

NCT02162212
2014_DM_LJM
US NIH Grant R21 DK100793-01A1 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

40 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

52 participants in 2 patient groups

ADA guideline Instructed
Active Comparator group
Description:
The control intervention will be instruction in basic wellness activities according to the American Diabetes Association guidelines
Treatment:
Other: ADA Guideline Instructed
Optimized Shoulder Movement Program
Experimental group
Description:
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" .
Treatment:
Other: Optimized Shoulder Movement Program

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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