Augmented Reality for Shoulder Pain and Scapular Dyskinesis

November 17, 2022 updated by: Ruben Fernandez Matias

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

Status

Indicates the current recruitment status or the expanded access status.
Suspended

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in pain intensity
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
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in shoulder 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
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
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
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
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
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
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
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
Time Frame: 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
Baseline, 1-month, 2-months, 3-months, and 6-months
Change in surface electromiography
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ruben Fernandez Matias

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2021

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings