Shoulder Impingement SyndromeNCT03554538
Efficacy of a Web App With Multimedia Animations to Teach Therapeutic Exercise in Shoulder Pain
A study testing Web app exercises program and Exercise program in people with Shoulder Impingement Syndrome, run by Universidad Complutense de Madrid.
Trial summary
The aim of this trial is to develop and evaluate a web app to teach patients about how to correctly perform a tailored program of shoulder exercises. The exercise program will be evidence based, and there will be two groups in the study, both exercising. The follow up will be of 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- Web app exercises program and Exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2019to Jun 2021
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 18 with uni or bilateral shoulder region pain
- Being able to read and write in Spanish
- Pain for at least 3 months
- Pain intensity (in rest, activity and/or at night) of at least 3/10
- Two positive clinical sings at least from: Neer sign, Hawkins-Kennedy sign, empty can or pain arc
- Must have and use at least 3 times/week email of their own and a device with internet connection
Who cannot join
- Polyarticular or generalized pain
- Cognitive impairment
- Cancer
- Serious neurological disease
- Other shoulder pain causes
- History of main trauma
Show all 11Show fewer
- Sings or symptoms of cervical pain (excluding upper trapezius) or cervical radiculopathy
- Apprehension sing, sulcus sing
- Passive movement limitation (but final degree in horizontal abduction or extension)
- Tendon rupture in ultrasound
- Glenohumeral arthritis in plain radiographs or calcium bigger than 5mm
Trial locations and contacts
No sites are listed yet.
Gustavo Plaza, PhD contact
About this study
Official title: Development and Evaluation of Efficacy of a Web App With Multimedia Animations to Teach Therapeutic Exercise in Shoulder Pain Patients
The aim of this trial is to develop and evaluate a web app to teach patients about how to correctly perform a tailored program of shoulder exercises.
The exercise program will be evidence based, and there will be two groups in the study, both exercising. The follow up will be of 6 months.
Read the detailed description
The web app will consist of 3D multimedia animations (video and audio) which the patient will be able to access from any device with internet connection (cell phone included).
The trial will include patients with shoulder pain because of rotator cuff tendinopathy.
The investigators will carry on a pilot study with 100 patients randomly distributed into two groups, with 6 months follow up. Both groups will perform the same treatment, but the control group won´t use the exercise app. There will be four dependent variables: correct exercise performance, compliance degree, satisfaction with the treatment and expectations to improve with treatment. As secondary dependent variables will be analyzed pain (at rest, with movement and at night), functional disability (SPADI questionnaire), and patient´s assessment of app video characteristics (usability, utility and satisfaction) and co-interventions.
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- Web app exercises program, Exercise program
- Keywords
- Shoulder impingement syndrome, Exercise web app, Efficacy
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Web app exercises programBehavioural
Exercise on an evidence based program for shoulder pain with web app animations to improve performance and adherence
Exercise programBehavioural
Exercise on an evidence based program for shoulder pain
| Study group | Role | What they receive |
|---|---|---|
| Web app exercises | Experimental | An evidence based exercise program for the shoulder pain. Web application with multimedia animations with the tailored exercise program for each patient in this group. Receives: Behavioral: Web app exercises program |
| Exercises | Active comparator | An evidence based exercise program for the shoulder pain. Receives: Behavioral: Exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correctness in exercise performance
25% of patients enrolled will be checked by video recording of 3 exercise performance, and the videos will be graded by two blinded assessors with a 6 points scale, 4 evaluating motor memory and 2 evaluating declaratory memory. Every exercise recording will be form 0 to 6, so the total score will range from 0 to 18.
Measured: 6 weeks
Compliance degree
It will be measured by a simple monthly diary where the patient will have to register everyday if has done or not the exercises and the degree of pain every week. Total score will correspond to the percentage of days exercising over the total expected.
Measured: 6 months
Treatment satisfaction: numerical visual scale
This outcome will be measured with a numerical visual scale of 11 points, where on the right will be "10" as completely satisfied, and on the left "0" absolutely unsatisfied.
Measured: 6 months
Expectancy of improvement with treatment
This outcome will be measured using a modified question from the "Credibility/expectancy Questionnaire", that will be pointed on a numerical visual scale of 11 points having on the right "10" as complete recovery, and on the left "0" as "no improvement". The question that will be made is "how much improvement do you think you will reach in your limitations because of the shoulder pain?"
Measured: 2 weeks
Secondary outcomes (3)
Pain intensity: numerical scale
Measured with a numerical scale with 11 points. 0 means "without pain" and 10 "worst pain". A 2 points change will be the minimum relevant clinical change.
Measured: 6 months
Functional limitation
Measured with the SPADI questionnaire adapted to spanish. Consists of 13 items, 5 evaluating pain and 8 disability. The total score ranges between 0 and 130, and the final score is a percentage. Higher scores mean a higher pain and disability degree. The minimal clinical change is 8 points. A 20 points change is needed for the patient to perceive an important change.
Measured: 6 months
Evaluation of the app and videos
A 12 points questionnaire, referred to usability, perceived usefulness and satisfaction. It´s a Likert type scale to express agreement on each question over 5 points, from complete disagreement to complete agreement. The total score is over 0- 100.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2018
- Study startNov 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Universidad Complutense de MadridThe sponsor's other registered studies.
- 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
- Model description
- There will be two randomized groups in a controlled clinical trial. The two groups will receive the same treatment based on an evidence-based exercise program taught by a physiotherapist, and one group will use the app multimedia to improve the performance and adherence. The other group won't use the app but a pamphlet, to follow exercises at home.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad Complutense de Madrid
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Fundación Alcorcón
- Responsible party
- Sponsor
- Investigators
- Mariano T Flórez, PhD, Principal investigator, Hospital Universitario Fundación Alcorcón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03554538
- Sponsor's protocol ID
- CI 18/16
- Status last verified
- Sep 2019
- First submitted
- 30 May 2018
- Last updated
- 1 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Evaluation of Efficacy of a Web App With Multimedia Animations to Teach Therapeutic Exercise in Shoulder Pain Patients
- ClinicalTrials.gov ID
- NCT03554538
- Acronym / sponsor ID
- CI 18/16
- Conditions
- Shoulder Impingement Syndrome
- Keywords
- Shoulder impingement syndrome, Exercise web app, Efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Universidad Complutense de MadridUniversity, hospital or other
- Collaborators
- Hospital Universitario Fundación Alcorcón
- Study start
- Nov 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 13 Jun 2018 (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 trial is to develop and evaluate a web app to teach patients about how to correctly perform a tailored program of shoulder exercises.
The exercise program will be evidence based, and there will be two groups in the study, both exercising. The follow up will be of 6 months.
Detailed description
The web app will consist of 3D multimedia animations (video and audio) which the patient will be able to access from any device with internet connection (cell phone included).
The trial will include patients with shoulder pain because of rotator cuff tendinopathy.
The investigators will carry on a pilot study with 100 patients randomly distributed into two groups, with 6 months follow up. Both groups will perform the same treatment, but the control group won´t use the exercise app. There will be four dependent variables: correct exercise performance, compliance degree, satisfaction with the treatment and expectations to improve with treatment. As secondary dependent variables will be analyzed pain (at rest, with movement and at night), functional disability (SPADI questionnaire), and patient´s assessment of app video characteristics (usability, utility and satisfaction) and co-interventions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There will be two randomized groups in a controlled clinical trial. The two groups will receive the same treatment based on an evidence-based exercise program taught by a physiotherapist, and one group will use the app multimedia to improve the performance and adherence. The other group won't use the app but a pamphlet, to follow exercises at home.
| Arm | Type | Receives |
|---|---|---|
| Web app exercises | Experimental | Behavioral: Web app exercises programAn evidence based exercise program for the shoulder pain. Web application with multimedia animations with the tailored exercise program for each patient in this group. |
| Exercises | Active comparator | Behavioral: Exercise programAn evidence based exercise program for the shoulder pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Older than 18 with uni or bilateral shoulder region pain
- Being able to read and write in Spanish
- Pain for at least 3 months
- Pain intensity (in rest, activity and/or at night) of at least 3/10
- Two positive clinical sings at least from: Neer sign, Hawkins-Kennedy sign, empty can or pain arc
Key exclusion criteria (11 listed)
- Polyarticular or generalized pain
- Cognitive impairment
- Cancer
- Serious neurological disease
- Other shoulder pain causes
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 |
|---|---|---|
| Web app exercises programExercise on an evidence based program for shoulder pain with web app animations to improve performance and adherence | Behavioural | Web app exercises |
| Exercise programExercise on an evidence based program for shoulder pain | Behavioural | Exercises |
Primary outcome
Correctness in exercise performance
Time frame: 6 weeks
25% of patients enrolled will be checked by video recording of 3 exercise performance, and the videos will be graded by two blinded assessors with a 6 points scale, 4 evaluating motor memory and 2 evaluating declaratory memory. Every exercise recording will be form 0 to 6, so the total score will range from 0 to 18.
Compliance degree
Time frame: 6 months
It will be measured by a simple monthly diary where the patient will have to register everyday if has done or not the exercises and the degree of pain every week. Total score will correspond to the percentage of days exercising over the total expected.
Treatment satisfaction: numerical visual scale
Time frame: 6 months
This outcome will be measured with a numerical visual scale of 11 points, where on the right will be "10" as completely satisfied, and on the left "0" absolutely unsatisfied.
Expectancy of improvement with treatment
Time frame: 2 weeks
This outcome will be measured using a modified question from the "Credibility/expectancy Questionnaire", that will be pointed on a numerical visual scale of 11 points having on the right "10" as complete recovery, and on the left "0" as "no improvement". The question that will be made is "how much improvement do you think you will reach in your limitations because of the shoulder pain?"
3 secondary outcomes
Pain intensity: numerical scale
Time frame: 6 months
Functional limitation
Time frame: 6 months
Evaluation of the app and videos
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
- Individual participant dataSharing planned: Undecided
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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.
Gustavo Plaza, PhD contact
Mariano T Flórez, PhD principal investigator
Hospital Universitario Fundación Alcorcón
Questions about this trial
What is this clinical trial studying?
A study testing Web app exercises program and Exercise program in people with Shoulder Impingement Syndrome, run by Universidad Complutense de Madrid.
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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Maria A Urraca, PT (+34916219721, aurraca@fhalcorcon.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correctness in exercise performance (time frame: 6 weeks). The study lists 4 primary outcomes in all. 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 1 Oct 2019.