Efficacy of a Web App With Multimedia Animations to Teach Therapeutic Exercise in Shoulder Pain

NCT ID: NCT03554538

Last Updated: 2019-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-30

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Shoulder Impingement Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The trial will be simple blinded because of the impossibility to blind patients nor physiotherapists to treatment.

Study Groups

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Web app exercises

An evidence based exercise program for the shoulder pain. Web application with multimedia animations with the tailored exercise program for each patient in this group.

Group Type EXPERIMENTAL

Web app exercises program

Intervention Type BEHAVIORAL

Exercise on an evidence based program for shoulder pain with web app animations to improve performance and adherence

Exercises

An evidence based exercise program for the shoulder pain.

Group Type ACTIVE_COMPARATOR

Exercise program

Intervention Type BEHAVIORAL

Exercise on an evidence based program for shoulder pain

Interventions

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Web app exercises program

Exercise on an evidence based program for shoulder pain with web app animations to improve performance and adherence

Intervention Type BEHAVIORAL

Exercise program

Exercise on an evidence based program for shoulder pain

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitario Fundación Alcorcón

OTHER

Sponsor Role collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mariano T Flórez, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Fundación Alcorcón

Central Contacts

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Maria A Urraca, PT

Role: CONTACT

+34916219721

Gustavo Plaza, PhD

Role: CONTACT

Other Identifiers

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CI 18/16

Identifier Type: -

Identifier Source: org_study_id

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