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Augmented Reality for Shoulder Pain and Scapular Dyskinesis

Primary Purpose

Shoulder Pain

Status
Suspended
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Augmented reality
Scapular repositioning exercise
Sponsored by
Ruben Fernandez Matias
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ruben Fernandez-Matias

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Agumented Reality combined with scapular exercises

Scapular exercises

Arm Description

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

Scapular exercises performed all the time without glasses.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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).
Change in kinesiophobia
Kinesiophobia measured with Tampa Scale of Kinesiophobia (TSK-11), which ranges from 0 (no kinesiophobia) to 100 (maximum degree of kinesiophobia)
Change in catastrophism
Pain catastrophism measured with Pain Catastrophism Scale (PCS), which ranges from 0 (no catastrophism) to 100 (severe catastrophism).
Change in shoulder range of motion
Shoulder range of motion in abduction, flexion, internal and external rotation, measured with a goniometer
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.

Full Information

First Posted
September 19, 2021
Last Updated
November 17, 2022
Sponsor
Ruben Fernandez Matias
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1. Study Identification

Unique Protocol Identification Number
NCT05088668
Brief Title
Augmented Reality for Shoulder Pain and Scapular Dyskinesis
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Suspended
Why Stopped
Logistic issues
Study Start Date
October 27, 2021 (Actual)
Primary Completion Date
May 1, 2022 (Actual)
Study Completion Date
December 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ruben Fernandez Matias

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The researchers involved in measuring outcomes will not be aware of treatment allocation.
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Agumented Reality combined with scapular exercises
Arm Type
Experimental
Arm Description
Scapular exercises performed with glasses of augmented reality during sessions at clinic, and without glasses at home.
Arm Title
Scapular exercises
Arm Type
Active Comparator
Arm Description
Scapular exercises performed all the time without glasses.
Intervention Type
Other
Intervention Name(s)
Augmented reality
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Scapular repositioning exercise
Intervention Description
Subjects will perform scapular repositioning exercises for improving scapular movement.
Primary Outcome Measure Information:
Title
Change in pain intensity
Description
Pain intensity measured with a visual analogue scale which ranges from 0 (no pain) to 10 (worst imaginable pain).
Time Frame
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 Measure Information:
Title
Change in shoulder disability
Description
Shoulder disability measured with Shoulder Pain and Disability Index (SPADI), which ranges from 0 (no disability) to 100 (maximum degree of disability).
Time Frame
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
Title
Change in arm disability
Description
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).
Time Frame
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
Title
Change in kinesiophobia
Description
Kinesiophobia measured with Tampa Scale of Kinesiophobia (TSK-11), which ranges from 0 (no kinesiophobia) to 100 (maximum degree of kinesiophobia)
Time Frame
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
Title
Change in catastrophism
Description
Pain catastrophism measured with Pain Catastrophism Scale (PCS), which ranges from 0 (no catastrophism) to 100 (severe catastrophism).
Time Frame
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
Title
Change in shoulder range of motion
Description
Shoulder range of motion in abduction, flexion, internal and external rotation, measured with a goniometer
Time Frame
Baseline, 1-month, 2-months, 3-months, and 6-months
Title
Change in surface electromiography
Description
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.
Time Frame
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Ruben Fernandez-Matias
City
Alcalá De Henares
ZIP/Postal Code
28805
Country
Spain

12. IPD Sharing Statement

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Augmented Reality for Shoulder Pain and Scapular Dyskinesis

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