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
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
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
NCT ID
NCT03554538
First Posted
May 30, 2018
Last Updated
September 28, 2019
Sponsor
Universidad Complutense de Madrid
Collaborators
Hospital Universitario Fundación Alcorcón
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
Learn more about this trial
Efficacy of a Web App With Multimedia Animations to Teach Therapeutic Exercise in Shoulder Pain
We'll reach out to this number within 24 hrs