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

NCT03554538 | Unknown DMC

• 1 other identifier: CI 18/16
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shoulder Impingement Syndrome

Keywords

Shoulder impingement syndrome; Exercise web app; Efficacy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Pain intensity: numerical scale

  6 months

• Functional limitation

  6 months

• Evaluation of the app and videos

  3 months

Study Arms (2)

Web app exercises

EXPERIMENTAL

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

Exercises

ACTIVE COMPARATOR

An evidence based exercise program for the shoulder pain.

Behavioral: Exercise program

Interventions

Web app exercises program BEHAVIORAL

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

Web app exercises

Exercise program BEHAVIORAL

Exercise on an evidence based program for shoulder pain

Exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Hospital Universitario Fundación Alcorcón: collaborator

MeSH Terms

Conditions

Shoulder Impingement Syndrome

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mariano T Flórez, PhD

  Hospital Universitario Fundación Alcorcón

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria A Urraca, PT

CONTACT

+34916219721; aurraca@fhalcorcon.es

Gustavo Plaza, PhD

CONTACT

gusplaza@ucm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The trial will be simple blinded because of the impossibility to blind patients nor physiotherapists to treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 30, 2018
• First Posted: June 13, 2018
• Study Start: November 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: June 1, 2021
• Last Updated: October 1, 2019

Record last verified: 2019-09