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Diabetic Shoulder Mobility

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162212
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : November 7, 2017
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Other: Optimized Shoulder Movement Program Other: ADA Guideline Instructed Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Diabetic Upper Extremity Pathophysiology, Limited Joint Mobility and Disability
Actual Study Start Date : September 2014
Actual Primary Completion Date : October 12, 2016
Actual Study Completion Date : October 12, 2016

Arm Intervention/treatment
Active Comparator: ADA guideline Instructed
The control intervention will be instruction in basic wellness activities according to the American Diabetes Association guidelines
Other: 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: Optimized Shoulder Movement Program
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
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 Outcome Measures :
  1. Arm elevation. [ Time Frame: One year ]
    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.


Secondary Outcome Measures :
  1. Disability of the Arm, Shoulder, and Hand (DASH) questionnaire [ Time Frame: One year ]
    The DASH is an established, standardized measure used to characterize pain and disability in the upper extremity.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162212


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63108
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Michael J Mueller, PT, PHD Washington University School of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02162212    
Other Study ID Numbers: 2014_DM_LJM
US NIH Grant R21 DK100793-01A1 ( Other Grant/Funding Number: US NIH Grant )
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017