Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Shoulder Pain

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: Completed
• Conditions: Rotator Cuff Tendinitis; Rotator Cuff Impingement Syndrome; Rotator Cuff Related Shoulder Pain
• Intervention / Treatment: Other: Therapeutic exercise program; Other: Multimedia animation information; Other: Paper-based information

• Study Type: Interventional
• Enrollment (Actual): 154
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in Shoulder Pain and Disability Index (SPADI)	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

Outcome Measure	Measure Description	Time Frame
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).	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).	Change from baseline to 3-week, and change from baseline to 6-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).	12-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.	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).	12-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)	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).	6-week, 12-week, and 24-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.	3-week, 6-week, 12-week, and 24-week

Collaborators and Investigators

• Sponsor: Hospital Universitario Fundación Alcorcón
• Collaborators: Instituto de Salud Carlos III; European Union

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2023
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 1, 2024

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 16, 2023

Study Record Updates

• Last Update Posted (Actual): May 30, 2025
• Last Update Submitted That Met QC Criteria: May 25, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Therapeutic Exercise; Rotator Cuff Related Shoulder Pain; Web-based video
• Additional Relevant MeSH Terms: Shoulder Injuries; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Wounds and Injuries; Joint Diseases; Rupture; Tendon Injuries; Arthralgia; Rotator Cuff Injuries; Shoulder Pain; Shoulder Impingement Syndrome; Tendinopathy
• Other Study ID 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