Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Shoulder Pain

NCT ID: NCT05770908

Last Updated: 2025-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-07

Study Completion Date

2024-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Rotator Cuff Impingement Syndrome Rotator Cuff Tendinitis Rotator Cuff Related Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
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Study Groups

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Multimedia animation videos plus paper-based therapeutic exercise program

Group Type EXPERIMENTAL

Therapeutic exercise program

Intervention Type 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 information

Intervention Type OTHER

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

Paper-based information

Intervention Type OTHER

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

Paper-based therapeutic exercise program

Group Type ACTIVE_COMPARATOR

Therapeutic exercise program

Intervention Type 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.

Paper-based information

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Multimedia animation information

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role collaborator

European Union

OTHER

Sponsor Role collaborator

Hospital Universitario Fundación Alcorcón

OTHER

Sponsor Role lead

Responsible Party

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Irene Pérez Porta

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Universitario Fundacion Alcorcon

Alcorcón, Madrid, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 39038866 (View on PubMed)

Other Identifiers

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CI18/16

Identifier Type: -

Identifier Source: org_study_id

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