Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Shoulder Pain

Hospital Universitario Fundación Alcorcón154 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

154

Conditions

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

Therapeutic exercise programOTHER

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 informationOTHER

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

Paper-based informationOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in Shoulder Pain and Disability Index (SPADI)

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 Outcomes

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).

Time frame: 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

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

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)

Time frame: 6-week, and 12-week

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).

Time frame: 6-week, 12-week, and 24-week

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.

Time frame: 12-week

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).

Time frame: 12-week

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).

Time frame: 12-week

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.

Time frame: 3-week, 6-week, 12-week, and 24-week

Multimedia Animations to Support Therapeutic Exercise for Rotator Cuff Shoulder Pain

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes