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

Development and Evaluation of Efficacy of a Web App With Multimedia Animations to Teach Therapeutic Exercise in Shoulder Pain Patients

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.

Study Overview

• Status: Unknown
• Conditions: Shoulder Impingement Syndrome
• Intervention / Treatment: Behavioral: Web app exercises program; Behavioral: Exercise program

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Web app exercises program; Exercise on an evidence based program for shoulder pain with web app animations to improve performance and adherence
Active Comparator: Exercises; An evidence based exercise program for the shoulder pain.	Behavioral: Exercise program; Exercise on an evidence based program for shoulder pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correctness in exercise performance	25% of patients enrolled will be checked by video recording of 3 exercise performance, and the videos will be graded by two blinded assessors with a 6 points scale, 4 evaluating motor memory and 2 evaluating declaratory memory. Every exercise recording will be form 0 to 6, so the total score will range from 0 to 18.	6 weeks
Compliance degree	It will be measured by a simple monthly diary where the patient will have to register everyday if has done or not the exercises and the degree of pain every week. Total score will correspond to the percentage of days exercising over the total expected.	6 months
Treatment satisfaction: numerical visual scale	This outcome will be measured with a numerical visual scale of 11 points, where on the right will be "10" as completely satisfied, and on the left "0" absolutely unsatisfied.	6 months
Expectancy of improvement with treatment	This outcome will be measured using a modified question from the "Credibility/expectancy Questionnaire", that will be pointed on a numerical visual scale of 11 points having on the right "10" as complete recovery, and on the left "0" as "no improvement". The question that will be made is "how much improvement do you think you will reach in your limitations because of the shoulder pain?"	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity: numerical scale	Measured with a numerical scale with 11 points. 0 means "without pain" and 10 "worst pain". A 2 points change will be the minimum relevant clinical change.	6 months
Functional limitation	Measured with the SPADI questionnaire adapted to spanish. Consists of 13 items, 5 evaluating pain and 8 disability. The total score ranges between 0 and 130, and the final score is a percentage. Higher scores mean a higher pain and disability degree. The minimal clinical change is 8 points. A 20 points change is needed for the patient to perceive an important change.	6 months
Evaluation of the app and videos	A 12 points questionnaire, referred to usability, perceived usefulness and satisfaction. It´s a Likert type scale to express agreement on each question over 5 points, from complete disagreement to complete agreement. The total score is over 0- 100.	3 months

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Collaborators: Hospital Universitario Fundación Alcorcón
• Investigators: Principal Investigator: Mariano T Flórez, PhD, Hospital Universitario Fundacion Alcorcon

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2019
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: May 30, 2018
• First Submitted That Met QC Criteria: June 12, 2018
• First Posted (Actual): June 13, 2018

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 28, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Efficacy; Shoulder impingement syndrome; Exercise web app
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Arthralgia; Shoulder Impingement Syndrome; Shoulder Pain
• Other Study ID Numbers: CI 18/16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No