Shoulder PainNCT05088668
Augmented Reality for Shoulder Pain and Scapular Dyskinesis
A study testing Augmented reality and Scapular repositioning exercise in people with Shoulder Pain, run by Ruben Fernandez Matias at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Augmented reality and Scapular repositioning exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSpain
- Study dates
- 27 Oct 2021to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Augmented reality, Scapular repositioning exercise
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Augmented realityOther
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 exerciseOther
Subjects will perform scapular repositioning exercises for improving scapular movement.
| Study group | Role | What they receive |
|---|---|---|
| Agumented Reality combined with scapular exercises | Experimental | Scapular exercises performed with glasses of augmented reality during sessions at clinic, and without glasses at home. Receives: Other: Augmented reality; Other: Scapular repositioning exercise |
| Scapular exercises | Active comparator | Scapular exercises performed all the time without glasses. Receives: Other: Scapular repositioning exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity
Pain intensity measured with a visual analogue scale which ranges from 0 (no pain) to 10 (worst imaginable pain).
Measured: 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
Shoulder disability measured with Shoulder Pain and Disability Index (SPADI), which ranges from 0 (no disability) to 100 (maximum degree of disability).
Measured: 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
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).
Measured: 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
Kinesiophobia measured with Tampa Scale of Kinesiophobia (TSK-11), which ranges from 0 (no kinesiophobia) to 100 (maximum degree of kinesiophobia)
Measured: 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
Pain catastrophism measured with Pain Catastrophism Scale (PCS), which ranges from 0 (no catastrophism) to 100 (severe catastrophism).
Measured: 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
Shoulder range of motion in abduction, flexion, internal and external rotation, measured with a goniometer
Measured: Baseline, 1-month, 2-months, 3-months, and 6-months
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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start27 Oct 2021
- Primary completion1 May 2022
- Study completion1 Dec 2028 (estimated)
Why it stopped: Logistic issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruben Fernandez Matias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruben Fernandez Matias, University of Alcala
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088668
- Sponsor's protocol ID
- 25072021
- Status last verified
- Nov 2022
- First submitted
- 19 Sep 2021
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05088668
- Acronym / sponsor ID
- 25072021
- Conditions
- Shoulder Pain
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Logistic issues
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Ruben Fernandez MatiasUniversity, hospital or other
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Agumented Reality combined with scapular exercises | Experimental | Other: Augmented reality, Other: Scapular repositioning exerciseScapular exercises performed with glasses of augmented reality during sessions at clinic, and without glasses at home. |
| Scapular exercises | Active comparator | Other: Scapular repositioning exerciseScapular exercises performed all the time without glasses. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Augmented realityThe 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 | Agumented Reality combined with scapular exercises |
| Scapular repositioning exerciseSubjects will perform scapular repositioning exercises for improving scapular movement. | Other | Agumented Reality combined with scapular exercises, Scapular exercises |
Primary outcome
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).
6 secondary outcomes
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
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
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
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
Change in shoulder range of motion
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented reality and Scapular repositioning exercise in people with Shoulder Pain, run by Ruben Fernandez Matias at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.