Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Shoulder Pain

Rotator Cuff Tendinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05770908
• Other study ID #: CI18/16
• Status: Recruiting
• Phase: N/A
• Start date: April 7, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Hospital Universitario Fundación Alcorcón
• Contact: Irene Perez Porta, MD
• Phone: 608873066
• Email: irenezerep1980[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 perform better the trained exercises? - 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Rotator Cuff Impingement Syndrome
• Rotator Cuff Injuries
• Rotator Cuff Tendinitis
• Shoulder Impingement Syndrome
• Shoulder Pain
• Tendinopathy

Intervention

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.
• Multimedia animation information
Multimedia animation videos (including audio) showing the performance of the prescribed exercises.
• Paper-based information
Paper-based information showing the performance of the prescribed exercises, based on figures and a brief description of the exercise performance.

Locations

Country	Name	City	State
Spain	Hospital Universitario Fundacion Alcorcon	Alcorcón	Madrid

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Universitario Fundación Alcorcón	European Union, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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)	12-week
Secondary	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
Secondary	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).	12-week
Secondary	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).	24-week
Secondary	Patient's ability to adequately perform the prescribed exercises	Patient's ability to adequately perform the prescribed exercises will be evaluated only in 20 subjects (ten from each group). It will be measured recording videotapes of the patient's performing the exercises, that will be rated by two independent investigators as good/bad performance, five times per exercise (three exercises overall).	6-week
Secondary	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
Secondary	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.	6-week
Secondary	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.	12-week
Secondary	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.	24-week
Secondary	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
Secondary	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
Secondary	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