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

Primary Purpose

Shoulder Impingement Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Web app exercises program
Exercise program
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Impingement Syndrome focused on measuring Shoulder impingement syndrome, Exercise web app, Efficacy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Web app exercises

    Exercises

    Arm 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.

    An evidence based exercise program for the shoulder pain.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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?"

    Secondary Outcome Measures

    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.
    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.
    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.

    Full Information

    First Posted
    May 30, 2018
    Last Updated
    September 28, 2019
    Sponsor
    Universidad Complutense de Madrid
    Collaborators
    Hospital Universitario Fundación Alcorcón
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03554538
    Brief Title
    Efficacy of a Web App With Multimedia Animations to Teach Therapeutic Exercise in Shoulder Pain
    Official Title
    Development and Evaluation of Efficacy of a Web App With Multimedia Animations to Teach Therapeutic Exercise in Shoulder Pain Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2019 (Anticipated)
    Primary Completion Date
    March 2020 (Anticipated)
    Study Completion Date
    June 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universidad Complutense de Madrid
    Collaborators
    Hospital Universitario Fundación Alcorcón

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Impingement Syndrome
    Keywords
    Shoulder impingement syndrome, Exercise web app, Efficacy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    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.
    Masking
    Outcomes Assessor
    Masking Description
    The trial will be simple blinded because of the impossibility to blind patients nor physiotherapists to treatment.
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Web app exercises
    Arm Type
    Experimental
    Arm 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.
    Arm Title
    Exercises
    Arm Type
    Active Comparator
    Arm Description
    An evidence based exercise program for the shoulder pain.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Web app exercises program
    Intervention Description
    Exercise on an evidence based program for shoulder pain with web app animations to improve performance and adherence
    Intervention Type
    Behavioral
    Intervention Name(s)
    Exercise program
    Intervention Description
    Exercise on an evidence based program for shoulder pain
    Primary Outcome Measure Information:
    Title
    Correctness in exercise performance
    Description
    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.
    Time Frame
    6 weeks
    Title
    Compliance degree
    Description
    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.
    Time Frame
    6 months
    Title
    Treatment satisfaction: numerical visual scale
    Description
    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.
    Time Frame
    6 months
    Title
    Expectancy of improvement with treatment
    Description
    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?"
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    Pain intensity: numerical scale
    Description
    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.
    Time Frame
    6 months
    Title
    Functional limitation
    Description
    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.
    Time Frame
    6 months
    Title
    Evaluation of the app and videos
    Description
    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.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Maria A Urraca, PT
    Phone
    +34916219721
    Email
    aurraca@fhalcorcon.es
    First Name & Middle Initial & Last Name or Official Title & Degree
    Gustavo Plaza, PhD
    Email
    gusplaza@ucm.es
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mariano T Flórez, PhD
    Organizational Affiliation
    Hospital Universitario Fundación Alcorcón
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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