Clinical trial NCT03554538: Efficacy of a Web App With Multimedia Animations to Teach Therapeutic Exercise in Shoulder Pain
Official title: Development and Evaluation of Efficacy of a Web App With Multimedia Animations to Teach Therapeutic Exercise in Shoulder Pain Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Impingement Syndrome
Keywords: Shoulder impingement syndrome
Exercise web app
Efficacy
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: Hospital Universitario Fundación Alcorcón
First posted: 2018-06-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two randomized groups in a controlled clinical trial. The two groups will receive the same treatment based on an evidence-based exercise program taught by a physiotherapist, and one group will use the app multimedia to improve the performance and adherence. The other group won't use the app but a pamphlet, to follow exercises at home.
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to develop and evaluate a web app to teach patients about how to correctly perform a tailored program of shoulder exercises.

The exercise program will be evidence based, and there will be two groups in the study, both exercising. The follow up will be of 6 months.

Detailed description: The web app will consist of 3D multimedia animations (video and audio) which the patient will be able to access from any device with internet connection (cell phone included).

The trial will include patients with shoulder pain because of rotator cuff tendinopathy.

The investigators will carry on a pilot study with 100 patients randomly distributed into two groups, with 6 months follow up. Both groups will perform the same treatment, but the control group won´t use the exercise app. There will be four dependent variables: correct exercise performance, compliance degree, satisfaction with the treatment and expectations to improve with treatment. As secondary dependent variables will be analyzed pain (at rest, with movement and at night), functional disability (SPADI questionnaire), and patient´s assessment of app video characteristics (usability, utility and satisfaction) and co-interventions.

Eligibility criteria: Inclusion Criteria:

* Older than 18 with uni or bilateral shoulder region pain
* Being able to read and write in Spanish
* Pain for at least 3 months
* Pain intensity (in rest, activity and/or at night) of at least 3/10
* Two positive clinical sings at least from: Neer sign, Hawkins-Kennedy sign, empty can or pain arc
* Must have and use at least 3 times/week email of their own and a device with internet connection

Exclusion Criteria:

* Polyarticular or generalized pain
* Cognitive impairment
* Cancer
* Serious neurological disease
* Other shoulder pain causes
* History of main trauma
* Sings or symptoms of cervical pain (excluding upper trapezius) or cervical radiculopathy
* Apprehension sing, sulcus sing
* Passive movement limitation (but final degree in horizontal abduction or extension)
* Tendon rupture in ultrasound
* Glenohumeral arthritis in plain radiographs or calcium bigger than 5mm

Primary outcomes:
measure: Correctness in exercise performance
timeFrame: 6 weeks
measure: Compliance degree
timeFrame: 6 months
measure: Treatment satisfaction: numerical visual scale
timeFrame: 6 months
measure: Expectancy of improvement with treatment
timeFrame: 2 weeks
Secondary outcomes:
measure: Pain intensity: numerical scale
timeFrame: 6 months
measure: Functional limitation
timeFrame: 6 months
measure: Evaluation of the app and videos
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Universitario Fundación Alcorcón
name: Mariano T Flórez, PhD
role: PRINCIPAL_INVESTIGATOR
References: