Augmented Reality for Shoulder Pain and Scapular Dyskinesis

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

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.

Study Overview

• Status: Suspended
• Conditions: Shoulder Pain
• Intervention / Treatment: Other: Augmented reality; Other: Scapular repositioning exercise

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alcalá De Henares, Spain, 28805
    • Rubén Fernández-Matías

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Agumented Reality combined with scapular exercises; Scapular exercises performed with glasses of augmented reality during sessions at clinic, and without glasses at home.	Other: Augmented reality; 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.; Other: Scapular repositioning exercise; Subjects will perform scapular repositioning exercises for improving scapular movement.
ACTIVE_COMPARATOR: Scapular exercises; Scapular exercises performed all the time without glasses.	Other: Scapular repositioning exercise; Subjects will perform scapular repositioning exercises for improving scapular movement.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ruben Fernandez Matias

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 27, 2021
• Primary Completion (ACTUAL): May 1, 2022
• Study Completion (ANTICIPATED): December 1, 2028

Study Registration Dates

• First Submitted: September 19, 2021
• First Submitted That Met QC Criteria: October 9, 2021
• First Posted (ACTUAL): October 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthralgia; Shoulder Pain
• Other Study ID Numbers: 25072021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No