Augmented Reality for Shoulder Pain and Scapular Dyskinesis

NCT05088668 | Suspended

• 1 other identifier: 25072021
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

• 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

• 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

• 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

• Change in shoulder range of motion

  Baseline, 1-month, 2-months, 3-months, and 6-months

Study Arms (2)

Agumented Reality combined with scapular exercises

EXPERIMENTAL

Scapular exercises performed with glasses of augmented reality during sessions at clinic, and without glasses at home.

Other: Augmented reality; Other: Scapular repositioning exercise

Scapular exercises

ACTIVE COMPARATOR

Scapular exercises performed all the time without glasses.

Other: Scapular repositioning exercise

Interventions

Augmented reality OTHER

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.

Agumented Reality combined with scapular exercises

Scapular repositioning exercise OTHER

Subjects will perform scapular repositioning exercises for improving scapular movement.

Agumented Reality combined with scapular exercises; Scapular exercises

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ruben Fernandez Matias: lead

Study Sites (1)

Ruben Fernandez-Matias

Alcalá de Henares, 28805, Spain

Location

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researchers involved in measuring outcomes will not be aware of treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: October 22, 2021
• Study Start: October 27, 2021
• Primary Completion: May 1, 2022
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 22, 2022

Record last verified: 2022-11

Locations

ES (1)