Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Shoulder Pain

NCT05770908 | Completed

• 1 other identifier: CI18/16
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Rotator Cuff Related Shoulder Pain; Therapeutic Exercise; Web-based video

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change in Pain intensity

  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

  Change from baseline to 3-week, and change from baseline to 6-week

• Patient's satisfaction

  6-week, and 12-week

• Patient's impression of improvement

  6-week, 12-week, and 24-week

• Patient's perceived usability of multimedia animations

  12-week

Study Arms (2)

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

Interventions

Therapeutic exercise program OTHER

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 videos plus paper-based therapeutic exercise program; Paper-based therapeutic exercise program

Multimedia animation information OTHER

Multimedia animation videos (including audio) showing the performance of the prescribed exercises.

Multimedia animation videos plus paper-based therapeutic exercise program

Paper-based information OTHER

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

Multimedia animation videos plus paper-based therapeutic exercise program; Paper-based therapeutic exercise program

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Fundación Alcorcón: lead
• Instituto de Salud Carlos III: collaborator
• European Union: collaborator

Study Sites (1)

Hospital Universitario Fundacion Alcorcon

Alcorcón, Madrid, 28922, Spain

Location

Related Publications (1)

• 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.

  PMID: 39038866 DERIVED

MeSH Terms

Conditions

Shoulder Impingement Syndrome; Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigators involved in the recruitment, and data analysis will be masked of participant's allocation group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: March 16, 2023
• Study Start: April 7, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)