Augmented Reality for Shoulder Pain and Scapular Dyskinesis

Not Applicable

Suspended

• Conditions: Shoulder Pain
• Interventions: Other: Scapular repositioning exercise; Other: Augmented reality

• Registration Number: NCT05088668
• Lead Sponsor: Ruben Fernandez Matias

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-09-19
• Study First Submitted QC: 2021-10-09
• Study First Posted: 2021-10-22
• Study Start: 2021-10-27
• Primary Completion: 2022-05-01
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-17
• Last Update Posted: 2022-11-22
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scapular exercises	Scapular repositioning exercise	Scapular exercises performed all the time without glasses.
Agumented Reality combined with scapular exercises	Scapular repositioning exercise	Scapular exercises performed with glasses of augmented reality during sessions at clinic, and without glasses at home.
Agumented Reality combined with scapular exercises	Augmented reality	Scapular exercises performed with glasses of augmented reality during sessions at clinic, and without glasses at home.

Primary Outcome Measures

Name	Time	Method
Change in pain intensity	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	Pain intensity measured with a visual analogue scale which ranges from 0 (no pain) to 10 (worst imaginable pain).

Secondary Outcome Measures

Name	Time	Method
Change in arm 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	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).
Change in shoulder 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	Shoulder disability measured with Shoulder Pain and Disability Index (SPADI), which ranges from 0 (no disability) to 100 (maximum degree of disability).
Change in 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	Kinesiophobia measured with Tampa Scale of Kinesiophobia (TSK-11), which ranges from 0 (no kinesiophobia) to 100 (maximum degree of kinesiophobia)
Change in shoulder range of motion	Baseline, 1-month, 2-months, 3-months, and 6-months	Shoulder range of motion in abduction, flexion, internal and external rotation, measured with a goniometer
Change in 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	Pain catastrophism measured with Pain Catastrophism Scale (PCS), which ranges from 0 (no catastrophism) to 100 (severe catastrophism).
Change in surface electromiography	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	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.

Trial Locations

Locations (1)

Ruben Fernandez-Matias; 🇪🇸 Alcalá De Henares, Spain