Back to resultsMultimedia Animations to Support Therapeutic Exercise for Rotator Cuff Shoulder Pain
Primary Purpose
Rotator Cuff Impingement Syndrome, Rotator Cuff Tendinitis, Rotator Cuff Related Shoulder Pain
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Therapeutic exercise program
Multimedia animation information
Paper-based information
Sponsored by
About this trial
This is an interventional treatment trial for Rotator Cuff Impingement Syndrome focused on measuring Rotator Cuff Related Shoulder Pain, Therapeutic Exercise, Web-based video
Eligibility Criteria
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.
Sites / Locations
- Hospital Universitario Fundacion AlcorconRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Multimedia animation videos plus paper-based therapeutic exercise program
Paper-based therapeutic exercise program
Arm Description
Outcomes
Primary Outcome Measures
Change in Shoulder Pain and Disability Index (SPADI)
The SPADI ranges from 0% (no disability) to 100% (maximum degree of disability)
Secondary Outcome Measures
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 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).
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)
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)
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).
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).
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).
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).
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.
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.
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.
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.
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).
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.
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).
Full Information
NCT ID
NCT05770908
First Posted
March 3, 2023
Last Updated
March 14, 2023
Sponsor
Hospital Universitario Fundación Alcorcón
Collaborators
Instituto de Salud Carlos III, European Union
1. Study Identification
Unique Protocol Identification Number
NCT05770908
Brief Title
Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Shoulder Pain
Official Title
Web Application Based on Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Related Shoulder Pain: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2022 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Universitario Fundación Alcorcón
Collaborators
Instituto de Salud Carlos III, European Union
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rotator Cuff Impingement Syndrome, Rotator Cuff Tendinitis, Rotator Cuff Related Shoulder Pain
Keywords
Rotator Cuff Related Shoulder Pain, Therapeutic Exercise, Web-based video
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
The investigators involved in the recruitment, and data analysis will be masked of participant's allocation group.
Allocation
Randomized
Enrollment
132 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Multimedia animation videos plus paper-based therapeutic exercise program
Arm Type
Experimental
Arm Title
Paper-based therapeutic exercise program
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Therapeutic exercise program
Intervention Description
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
Intervention Name(s)
Multimedia animation information
Intervention Description
Multimedia animation videos (including audio) showing the performance of the prescribed exercises.
Intervention Type
Other
Intervention Name(s)
Paper-based information
Intervention Description
Paper-based information showing the performance of the prescribed exercises, based on figures and a brief description of the exercise performance.
Primary Outcome Measure Information:
Title
Change in Shoulder Pain and Disability Index (SPADI)
Description
The SPADI ranges from 0% (no disability) to 100% (maximum degree of disability)
Time Frame
Change from baseline to 6-week, change from baseline to 12-week, and change from baseline to 24-week
Secondary Outcome Measure Information:
Title
Change in Pain intensity
Description
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).
Time Frame
Change from baseline to 6-week, change from baseline to 12-week, and change from baseline to 24-week
Title
Change in Patient's expectations of improvement
Description
Patient's expectations of improvement measured with a numeric rating scale, which ranges from 0 (no expectation of improvement) to 10 (full recovery expectation).
Time Frame
Change from baseline to 3-week, and change from baseline to 6-week
Title
Patient's satisfaction
Description
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)
Time Frame
6-week
Title
Patient's satisfaction
Description
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)
Time Frame
12-week
Title
Patient's impression of improvement
Description
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).
Time Frame
6-week
Title
Patient's impression of improvement
Description
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).
Time Frame
12-week
Title
Patient's impression of improvement
Description
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).
Time Frame
24-week
Title
Patient's ability to adequately perform the prescribed exercises
Description
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).
Time Frame
6-week
Title
Patient's adherence
Description
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.
Time Frame
3-week
Title
Patient's adherence
Description
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.
Time Frame
6-week
Title
Patient's adherence
Description
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.
Time Frame
12-week
Title
Patient's adherence
Description
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.
Time Frame
24-week
Title
Patient's satisfaction with the multimedia animations
Description
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).
Time Frame
12-week
Title
Patient's perceived usability of multimedia animations
Description
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.
Time Frame
12-week
Title
Patient's perceived usefulness of multimedia animations
Description
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).
Time Frame
12-week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irene Perez Porta, MD
Phone
608873066
Ext
+34
Email
irenezerep1980@gmail.com
Facility Information:
Facility Name
Hospital Universitario Fundacion Alcorcon
City
Alcorcón
State/Province
Madrid
ZIP/Postal Code
28922
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irene Perez Porta, MD
Phone
608873066
Ext
+34
Email
irenezerep1980@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Shoulder Pain
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