Augmented Reality for Shoulder Pain and Scapular Dyskinesis

Shoulder Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05088668
• Other study ID #: 25072021
• Status: Suspended
• Phase: N/A
• Start date: October 27, 2021
• Est. completion date: December 1, 2028

Study information

• Verified date: November 2022
• Source: University of Alcala
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 52
• Est. completion date: December 1, 2028
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

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.
• Scapular repositioning exercise
Subjects will perform scapular repositioning exercises for improving scapular movement.

Locations

Country	Name	City	State
Spain	Ruben Fernandez-Matias	Alcalá De Henares

Sponsors (1)

Lead Sponsor	Collaborator
Ruben Fernandez Matias

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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