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

Shoulder Impingement Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03554538
• Other study ID #: CI 18/16
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2019
• Est. completion date: June 2021

Study information

• Verified date: September 2019
• Source: Universidad Complutense de Madrid
• Contact: Maria A Urraca, PT
• Phone: +34916219721
• Email: aurraca[@]fhalcorcon.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 2021
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Shoulder Pain

Intervention

Behavioral:
• Web app exercises program
Exercise on an evidence based program for shoulder pain with web app animations to improve performance and adherence
• Exercise program
Exercise on an evidence based program for shoulder pain

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Hospital Universitario Fundación Alcorcón

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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