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

September 28, 2019 updated by: Universidad Complutense de Madrid

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Correctness in exercise performance
Time Frame: 6 weeks
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
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 2 weeks
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pain intensity: numerical scale
Time Frame: 6 months
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
Time Frame: 6 months
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
Time Frame: 3 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad Complutense de Madrid

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Hospital Universitario Fundación Alcorcón

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mariano T Flórez, PhD, Hospital Universitario Fundación Alcorcón

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 30, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 1, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 28, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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