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

U

Universidad Complutense de Madrid

Status

Unknown

Conditions

Shoulder Impingement Syndrome

Treatments

Behavioral: Exercise program
Behavioral: Web app exercises program

Study type

Interventional

Funder types

Other

Identifiers

NCT03554538
CI 18/16

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

100 participants in 2 patient groups

Web app exercises
Experimental group
Description:
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.
Treatment:
Behavioral: Web app exercises program
Exercises
Active Comparator group
Description:
An evidence based exercise program for the shoulder pain.
Treatment:
Behavioral: Exercise program

Trial contacts and locations

0

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Central trial contact

Maria A Urraca, PT; Gustavo Plaza, PhD

Data sourced from clinicaltrials.gov

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