Diabetic Shoulder Mobility

Diabetes Mellitus Clinical Trial

Official title:

Diabetic Upper Extremity Pathophysiology, Limited Joint Mobility and Disability

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02162212
• Other study ID #: 2014_DM_LJM
• Secondary ID: US NIH Grant R21
• Status: Completed
• Phase: N/A
• First received: June 9, 2014
• Last updated: November 3, 2017
• Start date: September 2014
• Est. completion date: October 12, 2016

Study information

• Verified date: November 2017
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: October 12, 2016
• Est. primary completion date: October 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arm elevation.	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.	One year
Secondary	Disability of the Arm, Shoulder, and Hand (DASH) questionnaire	The DASH is an established, standardized measure used to characterize pain and disability in the upper extremity.	One year