Augmented Reality for Shoulder Pain and Scapular Dyskinesis

Study Overview
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Brief Summary
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The aim of this study is to analyze whether an Augmented Reality based scapular stabilization exercise program is more effective than conventional programs in patients with chronic shoulder pain and Scapular Dyskinesis.

Official Title
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The Effectiveness of Augmented Reality Combined With Scapular Repositioning Exercises in Patients With Chronic Shoulder Pain and Scapular Dyskinesis: a Randomized Clinical Trial

Conditions
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Shoulder Pain

Intervention / Treatment
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* Other: Augmented reality
* Other: Scapular repositioning exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral mechanical shoulder pain of nonspecific origin (non-traumatic) lasting at least 3 months. Weakness in flexion, abduction and/or external rotation isometric strength testing. Presence of scapular dyskinesis according to Kibler, Scapular Assistance Test, and Scapular Reposition Test. Exclusion Criteria: Previous shoulder surgery. History of shoulder fracture or glenohumeral luxation. History of acromioclavicular joint injury. Presence of massive rotator cuff rears. Presence of frozen shoulder. Cervical hernias or radiculopathy. Fibromyalgia. Neuropathic pain. Cervical and/or vestibular problems with dizziness, unsteadiness, or vertigo. Medical contraindication for performing exercise (cardio-vascular or cardio-pulmonar diseases, systemic diseases, metabolic diseases in non-controlled acute state). Blindness. Actually being treated with physical therapy for shoulder pain.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Agumented Reality combined with scapular exercises<br>Scapular exercises performed with glasses of augmented reality during sessions at clinic, and without glasses at home. | Other: Augmented reality<br>* The subjects will perform scapular repositioning exercise using glasses of augmented reality to see their scapular movement simultaneously. Furthermore, they will also see at the same time a video record of an ideal scapular movement, and will me encouraged to simulate that ideal scapular movement.<br>Other: Scapular repositioning exercise<br>* Subjects will perform scapular repositioning exercises for improving scapular movement.<br>|
| Active Comparator: Scapular exercises<br>Scapular exercises performed all the time without glasses. | Other: Scapular repositioning exercise<br>* Subjects will perform scapular repositioning exercises for improving scapular movement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pain intensity | Pain intensity measured with a visual analogue scale which ranges from 0 (no pain) to 10 (worst imaginable pain). | Baseline, change from baseline at 1-month, change from baseline at 2-months, change from baseline at 3-months, and change from baseline at 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in shoulder disability | Shoulder disability measured with Shoulder Pain and Disability Index (SPADI), which ranges from 0 (no disability) to 100 (maximum degree of disability). | Baseline, change from baseline at 1-month, change from baseline at 2-months, change from baseline at 3-months, and change from baseline at 6-months | 
| Change in arm disability | Arm disability measured with Disabilities of the Arm, Shoulder, and Hand (Quick-DASH), which ranges from 0 (no disability) to 100 (maximum degree of disability). | Baseline, change from baseline at 1-month, change from baseline at 2-months, change from baseline at 3-months, and change from baseline at 6-months | 
| Change in kinesiophobia | Kinesiophobia measured with Tampa Scale of Kinesiophobia (TSK-11), which ranges from 0 (no kinesiophobia) to 100 (maximum degree of kinesiophobia) | Baseline, change from baseline at 1-month, change from baseline at 2-months, change from baseline at 3-months, and change from baseline at 6-months | 
| Change in catastrophism | Pain catastrophism measured with Pain Catastrophism Scale (PCS), which ranges from 0 (no catastrophism) to 100 (severe catastrophism). | Baseline, change from baseline at 1-month, change from baseline at 2-months, change from baseline at 3-months, and change from baseline at 6-months | 
| Change in shoulder range of motion | Shoulder range of motion in abduction, flexion, internal and external rotation, measured with a goniometer | Baseline, 1-month, 2-months, 3-months, and 6-months | 
| Change in surface electromiography | Electromiographic activity of serratus anterior, upper trapezius, lower trapezius, and deltoid medimum muscles. Percent of electromiographic activity as a function of maximum voluntary isometric contraction, as well as latency of muscle activation during scaption will be recorded. | Baseline, change from baseline at 1-month, change from baseline at 2-months, change from baseline at 3-months, and change from baseline at 6-months |