Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Shoulder Pain

May 25, 2025 updated by: Irene Pérez Porta, Hospital Universitario Fundación Alcorcón

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.

Study Overview

Status

Status

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

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 (Actual)

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.
154

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Hospital Universitario Fundación Alcorcón

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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 Assignment
  • 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: Multimedia animation videos plus paper-based therapeutic exercise program
Other: Therapeutic exercise program

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.
Other: Multimedia animation information
Multimedia animation videos (including audio) showing the performance of the prescribed exercises.
Other: Paper-based information
Paper-based information showing the performance of the prescribed exercises, based on figures and a brief description of the exercise performance.
Active Comparator: Paper-based therapeutic exercise program
Other: Therapeutic exercise program

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.
Other: Paper-based information
Paper-based information showing the performance of the prescribed exercises, based on figures and a brief description of the exercise performance.

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 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)
Change from baseline to 6-week, change from baseline to 12-week, and change from baseline to 24-week

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 Pain intensity
Time Frame: Change from baseline to 6-week, change from baseline to 12-week, and change from baseline to 24-week
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).
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 expectations of improvement measured with a numeric rating scale, which ranges from 0 (no expectation of improvement) to 10 (full recovery expectation).
Change from baseline to 3-week, and change from baseline to 6-week
Patient's satisfaction with the multimedia animations
Time Frame: 12-week
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).
12-week
Patient's perceived usability of multimedia animations
Time Frame: 12-week
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.
12-week
Patient's perceived usefulness of multimedia animations
Time Frame: 12-week
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).
12-week
Patient's satisfaction
Time Frame: 6-week, and 12-week
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)
6-week, and 12-week
Patient's impression of improvement
Time Frame: 6-week, 12-week, and 24-week
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).
6-week, 12-week, and 24-week
Patient's adherence
Time Frame: 3-week, 6-week, 12-week, and 24-week
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.
3-week, 6-week, 12-week, and 24-week

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.
Hospital Universitario Fundación Alcorcón

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Instituto de Salud Carlos III
European Union

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.
April 7, 2023

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.
December 1, 2024

Study Completion (Actual)

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, 2024

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).
March 3, 2023

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.
March 14, 2023

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.
March 16, 2023

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.
May 30, 2025

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.
May 25, 2025

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.
May 1, 2025

More Information

Terms related to this study

Keywords

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.
  • CI18/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

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