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Completed

NCT Number: NCT05770908

Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Shoulder Pain

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.

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Key information

Conditions

Rotator Cuff Impingement Syndrome Joint Diseases Musculoskeletal Diseases Rotator Cuff Injuries Rotator Cuff Related Shoulder Pain Rotator Cuff Tendinitis Rupture Shoulder Impingement Syndrome Shoulder Injuries Tendon Injuries Wounds and Injuries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Fundacion Alcorcon

Alcorcón, Madrid, 28922, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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 information

Other

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

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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).

  2. 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).

  3. 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)

  4. 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).

  5. 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.

  6. 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).

  7. 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).

  8. 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.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Fundación Alcorcón

Other

Collaborators

  • European Union
  • Instituto de Salud Carlos III

Registry information

Official study title

Web Application Based on Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 16, 2023
Registry last updated
May 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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