Diabetic Shoulder Mobility

NCT02162212 | Completed DMC

• 2 other identifiers: 2014_DM_LJMUS NIH Grant R21 DK100793-01A1
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Disability of the Arm, Shoulder, and Hand (DASH) questionnaire

  One year

Study Arms (2)

ADA guideline Instructed

ACTIVE COMPARATOR

The control intervention will be instruction in basic wellness activities according to the American Diabetes Association guidelines

Other: ADA Guideline Instructed

Optimized Shoulder Movement Program

EXPERIMENTAL

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

Interventions

Optimized Shoulder Movement Program OTHER

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.

Optimized Shoulder Movement Program

ADA Guideline Instructed OTHER

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.

ADA guideline Instructed

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Related Publications (1)

• 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.

  PMID: 29893977 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Michael J Mueller, PT, PHD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2014
• First Posted: June 12, 2014
• Study Start: September 1, 2014
• Primary Completion: October 12, 2016
• Study Completion: October 12, 2016
• Last Updated: November 7, 2017

Record last verified: 2017-11

Locations

US (1)