Rotator Cuff Impingement SyndromeNCT05770908
Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Shoulder Pain
A study testing Therapeutic exercise program, Multimedia animation information and Paper-based information in people with Rotator Cuff Impingement Syndrome and Rotator Cuff Tendinitis, run by Hospital Universitario Fundación Alcorcón at 1 site in Spain.
Trial summary
The goal of this randomized controlled trial is to evaluate the benefits from adding multimedia animations to a paper-based therapeutic exercise program in subjects with rotator cuff related shoulder pain. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rotator Cuff Impingement Syndrome, Rotator Cuff Tendinitis, Rotator Cuff Related Shoulder Pain
- What is being tested?
- Therapeutic exercise program, Multimedia animation information and Paper-based information
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 1 siteSpain
- Study dates
- 7 Apr 2023to 1 Dec 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presence of rotator cuff related shoulder pain, diagnosed as unilateral shoulder pain, located in the anterior and/or lateral deltoid region, which is reproduced by active elevation and/or lying on ipsilateral side, and with at least one the following orthopaedic tests: Neer, Hawkins-Kennedy and/or empty can.
- Pain lasting from at least 3-months.
- Pain intensity at rest, during movement, and sleeping ≥ 3/10 points on a numeric pain rating scale.
- To have a mobile phone, tablet or computer with internet connection.
- To understand written and spoken Spanish language.
Who cannot join
- History of major trauma or surgery on the shoulder, elbow, or cervical spine.
- Signs of other shoulder pathologies such as instability, frozen shoulder, calcific tendonitis, severe arthrosis, or neuralgic amyotrophy.
- Presence of full-thickness rotator cuff tears on ultrasound imaging.
- Signs and/or symptoms of neck-related shoulder pain and/or radiculopathy or radicular pain.
- Systemic diseases such as cancer, rheumatic disorders, sclerosis multiple, neurological disorders, etc.
- Severe psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Web Application Based on Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial
The goal of this randomized controlled trial is to evaluate the benefits from adding multimedia animations to a paper-based therapeutic exercise program in subjects with rotator cuff related shoulder pain. The main question[s] it aims to answer are:
- Does subjects improve more regarding shoulder disability and pain?
- Are the subjects more satisfied with the treatment received?
- Do the subjects adhere more to the exercise program?
- Do the subjects have greater expectations with the treatment received? Participants will perform a therapeutic exercise program within 6 months. Researchers will compare the addition of web-app animations to the classical paper-based information.
- Conditions
- Rotator Cuff Impingement Syndrome, Rotator Cuff Tendinitis, Rotator Cuff Related Shoulder Pain
- Being tested
- Therapeutic exercise program, Multimedia animation information, Paper-based information
- Keywords
- Rotator Cuff Related Shoulder Pain, Therapeutic Exercise, Web-based video
- Medical subject headings
- Shoulder Impingement Syndrome, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic exercise programOther
Therapeutic exercise program based on increasing resistance with elastic bands or weights. The programmes are composed of combinations of the following exercises:
- Scaption with elastic band.
- External rotation at 0º of abduction with elastic band.
- Internal rotation at 0º of abduction with elastic band.
- Shoulder protraction in supine position with weights.
- Low row with elastic band.
- Horizontal adduction stretching.
Multimedia animation informationOther
Multimedia animation videos (including audio) showing the performance of the prescribed exercises.
Paper-based informationOther
Paper-based information showing the performance of the prescribed exercises, based on figures and a brief description of the exercise performance.
| Study group | Role | What they receive |
|---|---|---|
| Multimedia animation videos plus paper-based therapeutic exercise program | Experimental | Not described Receives: Other: Therapeutic exercise program; Other: Multimedia animation information; Other: Paper-based information |
| Paper-based therapeutic exercise program | Active comparator | Not described Receives: Other: Therapeutic exercise program; Other: Paper-based information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Shoulder Pain and Disability Index (SPADI)
The SPADI ranges from 0% (no disability) to 100% (maximum degree of disability)
Measured: Change from baseline to 6-week, change from baseline to 12-week, and change from baseline to 24-week
Secondary outcomes (8)
Change in Pain intensity
Mean pain intensity during last week (at rest, with movement, and at night) measured with a numeric pain rating scale, which ranges from zero (no pain) to 10 (worst pain imaginable).
Measured: Change from baseline to 6-week, change from baseline to 12-week, and change from baseline to 24-week
Change in Patient's expectations of improvement
Patient's expectations of improvement measured with a numeric rating scale, which ranges from 0 (no expectation of improvement) to 10 (full recovery expectation).
Measured: Change from baseline to 3-week, and change from baseline to 6-week
Patient's satisfaction
Patient's satisfaction with received treatment measured with a numeric rating scale, which ranges from zero (not at all satisfied with the treatment received) to 10 (fully satisfied with the treatment received)
Measured: 6-week, and 12-week
Patient's impression of improvement
Patient's impression of improvement measured with the Patient Global Impression of Improvement (PGI-I) scale. The PGI-I is an seven-point ordinal scale ranging from 1 (much worse), through 3 (no change), to 6 (very much better).
Measured: 6-week, 12-week, and 24-week
Patient's perceived usability of multimedia animations
Patient's perceptions on the usability of the multimedia animations measured with the System Usability Scale (SUS), which is composed of 10 items that are rated in a 5-point Likert-type scale from 1 (strongly disagree) to 5 (strongly agree), with an overall rating ranging from 0% of perceived usability to 100% of perceived usability.
Measured: 12-week
Patient's perceived usefulness of multimedia animations
Patient's perceived usefulness of multimedia animations measured with a 5-point Likert-type scale, which ranges from 1 (strongly disagree) to 5 (strongly agree).
Measured: 12-week
Patient's satisfaction with the multimedia animations
Patient's satisfaction with the multimedia animations measured with a 5-point Likert-type scale, which ranges from 1 (strongly disagree) to 5 (strongly agree).
Measured: 12-week
Patient's adherence
Patient's home adherence to the prescribed exercises measured with self-registered calendars, as the percentage of days performing the exercise at home over the maximum days available between the first physical therapy session and the last follow-up.
Measured: 3-week, 6-week, 12-week, and 24-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start7 Apr 2023
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rotator Cuff Impingement SyndromeStudies 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
- Investigator
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario Fundación Alcorcón
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, European Union
- Responsible party
- Principal investigator, Irene Pérez Porta, Hospital Universitario Fundación Alcorcón
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05770908
- Sponsor's protocol ID
- CI18/16
- Status last verified
- May 2025
- First submitted
- 3 Mar 2023
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Perez-Porta I, Florez-Garcia MT, Garcia-Perez F, Fernandez-Matias R, Perez-Manzanero MA, Araujo-Narvaez AM, Urraca-Gesto MA, Fernandez-Lagarejos C, Plaza-Manzano G, Perez-Fernandez E, Velasco-Arribas M. Effects of a web application based on multimedia animations to support therapeutic exercise for rotator cuff-related shoulder pain: protocol for an open-label randomised controlled trial. BMJ Open. 2024 Jul 22;14(7):e085381. doi: 10.1136/bmjopen-2024-085381.
PubMed 39038866
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web Application Based on Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05770908
- Acronym / sponsor ID
- CI18/16
- Conditions
- Rotator Cuff Impingement Syndrome, Rotator Cuff Tendinitis, Rotator Cuff Related Shoulder Pain
- Keywords
- Rotator Cuff Related Shoulder Pain, Therapeutic Exercise, Web-based video
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Hospital Universitario Fundación AlcorcónUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, European Union
- Study start
- 7 Apr 2023 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 16 Mar 2023 (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 goal of this randomized controlled trial is to evaluate the benefits from adding multimedia animations to a paper-based therapeutic exercise program in subjects with rotator cuff related shoulder pain. The main question[s] it aims to answer are:
- Does subjects improve more regarding shoulder disability and pain?
- Are the subjects more satisfied with the treatment received?
- Do the subjects adhere more to the exercise program?
- Do the subjects have greater expectations with the treatment received? Participants will perform a therapeutic exercise program within 6 months. Researchers will compare the addition of web-app animations to the classical paper-based information.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multimedia animation videos plus paper-based therapeutic exercise program | Experimental | Other: Therapeutic exercise program, Other: Multimedia animation information, Other: Paper-based information |
| Paper-based therapeutic exercise program | Active comparator | Other: Therapeutic exercise program, Other: Paper-based information |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presence of rotator cuff related shoulder pain, diagnosed as unilateral shoulder pain, located in the anterior and/or lateral deltoid region, which is reproduced by active elevation and/or lying on ipsilateral side, and with at least one the following orthopaedic tests: Neer, Hawkins-Kennedy and/or empty can.
- Pain lasting from at least 3-months.
- Pain intensity at rest, during movement, and sleeping ≥ 3/10 points on a numeric pain rating scale.
- To have a mobile phone, tablet or computer with internet connection.
- To understand written and spoken Spanish language.
Key exclusion criteria (6 listed)
- History of major trauma or surgery on the shoulder, elbow, or cervical spine.
- Signs of other shoulder pathologies such as instability, frozen shoulder, calcific tendonitis, severe arthrosis, or neuralgic amyotrophy.
- Presence of full-thickness rotator cuff tears on ultrasound imaging.
- Signs and/or symptoms of neck-related shoulder pain and/or radiculopathy or radicular pain.
- Systemic diseases such as cancer, rheumatic disorders, sclerosis multiple, neurological disorders, etc.
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 |
|---|---|---|
| Therapeutic exercise programTherapeutic exercise program based on increasing resistance with elastic bands or weights. The programmes are composed of combinations of the following exercises: * Scaption with elastic band. * External rotation at 0º of abduction with elastic band. * Internal rotation at 0º of abduction with elastic band. * Shoulder protraction in supine position with weights. * Low row with elastic band. * Horizontal adduction stretching. | Other | Multimedia animation videos plus paper-based therapeutic exercise program, Paper-based therapeutic exercise program |
| Multimedia animation informationMultimedia animation videos (including audio) showing the performance of the prescribed exercises. | Other | Multimedia animation videos plus paper-based therapeutic exercise program |
| Paper-based informationPaper-based information showing the performance of the prescribed exercises, based on figures and a brief description of the exercise performance. | Other | Multimedia animation videos plus paper-based therapeutic exercise program, Paper-based therapeutic exercise program |
Primary outcome
Change in Shoulder Pain and Disability Index (SPADI)
Time frame: Change from baseline to 6-week, change from baseline to 12-week, and change from baseline to 24-week
The SPADI ranges from 0% (no disability) to 100% (maximum degree of disability)
8 secondary outcomes
Change in Pain intensity
Time frame: Change from baseline to 6-week, change from baseline to 12-week, and change from baseline to 24-week
Change in Patient's expectations of improvement
Time frame: Change from baseline to 3-week, and change from baseline to 6-week
Patient's satisfaction
Time frame: 6-week, and 12-week
Patient's impression of improvement
Time frame: 6-week, 12-week, and 24-week
Patient's perceived usability of multimedia animations
Time frame: 12-week
Patient's perceived usefulness of multimedia animations
Time frame: 12-week
Patient's satisfaction with the multimedia animations
Time frame: 12-week
Patient's adherence
Time frame: 3-week, 6-week, 12-week, and 24-week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 39038866Perez-Porta I, Florez-Garcia MT, Garcia-Perez F, Fernandez-Matias R, Perez-Manzanero MA, Araujo-Narvaez AM, Urraca-Gesto MA, Fernandez-Lagarejos C, Plaza-Manzano G, Perez-Fernandez E, Velasco-Arribas M. Effects of a web application based on multimedia animations to support therapeutic exercise for rotator cuff-related shoulder pain: protocol for an open-label randomised controlled trial. BMJ Open. 2024 Jul 22;14(7):e085381. doi: 10.1136/bmjopen-2024-085381.
- Individual participant dataSharing planned: No
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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 Therapeutic exercise program, Multimedia animation information and Paper-based information in people with Rotator Cuff Impingement Syndrome and Rotator Cuff Tendinitis, run by Hospital Universitario Fundación Alcorcón 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 30 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Shoulder Pain and Disability Index (SPADI) (time frame: Change from baseline to 6-week, change from baseline to 12-week, and change from baseline to 24-week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05770908, which also lists 1 linked publication.
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 30 May 2025.