Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis

April 2, 2026 updated by: Dr. Antonio I Cuesta-Vargas, University of Malaga

Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis: a Randomized Controlled Trial.

The present study try to evaluate the effectivenness of an early intervention program based on multimodal physiotherapy and focused on therapeutic exercise to improve the results of patients with a reverse shoulder phrostesis. This trial will be a randomized controlled trial with parallel groups, and outcomes variables will include psychometric properties through the use of specific questionnaries, and laboratory variables such as strength with a dynamometer, range of movement with a goniometer, muscle mass with an ultrasound, and kinematic parameters with inertial sensors. This study aims to develop an original intervention program in order to try to establish new protocols in the management of these patients.

Study Overview

Status

Status

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

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

Background: Shoulder fractures, shoulder osteoarthritis and rheumatoid arthritis have a high prevalence and many times they require a surgery, in which a reverse shoulder phrostesis is colocated. Nonetheless, nowadays there is no a clear consensus protocol in order to manage the prehabilitation and rehabilitation of this patient, so each physiotherapist use different techniques to treat this pathology.

Objective: This study aims to evaluate the effectiveness of an original intervention program (REMOVE program) focused on an early intervention based on therapeutic exercise, manual therapy and education to improve the functionality of these patients after surgery.

Methods: This study is a randomized controlled trial with parallel groups. The control group receive standard care, and the experimental group is subjected to the REMOVE program. Both groups are evaluated five times, pre-surgery, at baseline, at 6 weeks, at 12 weeks and at 24 weeks to assess psychometric and laboratory outcomes.

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 (Estimated)

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.
40

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.
  • Name: Antonio I Cuesta-Vargas, PhD
  • Phone Number: (+34) 667 45 55 44
  • Email: acuesta@uma.es

Study Locations

  • Spain
      • Málaga, Spain
        • Recruiting
        • Antonio Cuesta Vargas
        • Principal Investigator:
          • Cuesta Vargas A Antonio Ignacio, PhD
        • Contact:
          • Antonio Ignacio, Cuesta Vargas, PhD
          • Phone Number: +34 952137551
          • Email: acuesta@uma.es

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults with a reverse shoulder prosthesis.
  • Age between 18 and 90 years.
  • Signed informed consent.

Exclusion Criteria:

  • Language or cultural barriers.
  • Other upper limb injury.
  • Treatment that affect physical activity capacity.

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: Double

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.
Active Comparator: CONTROL GROUP - STANDARD PHYSIOTHERAPY
Patients will undergo standard care which consists of an initial consultation with the physiotherapist to receive some recommendations about exercises, progression and health education
Other: CONTROL
Patients will undergo standard care which consists of an initial consultation with the physiotherapist to receive some recommendations about exercises, progression and health education
Experimental: EXPERIMENTAL GROUP - REMOVE PROGRAM

INITIAL STAGE:

  • Aim: Recover mobility
  • Exercises: Passive therapy, isometric exercises focused on middle deltoid.
  • Goal: 80º passive flexion, 45º abduction, 5 N of abduction force STRENGTHENING STAGE
  • Aim: Enhance scapulohumeral rhythm and strength rotator cura
  • Exercises: Active-assisted therapy, isotonic exercises between 45-90º of forward flexión and abduction with dumbbells and isometric exercises focused on internal and external rotation.
  • Goal: 100º passive flexion, 90º lateral abduction, 10 N of abduction force INTENSIVE STAGE
  • Aim: Improve motor control and increase cross-sectional muscular área
  • Exercises: Rowe with resistance band, wall push ups, lateral elevation with dumbbles, active external and internal rotation.
  • Goal: 15 N of abduction force FUNCTIONAL STAGE
  • Aim: Develope daily life activities
  • Exercises: Overhead tasks, rowe with Kettlebell, internal and external rotations with resistance bands
  • Goal: 20 N of abduction force
Other: REMOVE

INITIAL STAGE:

  • Aim: Recover mobility
  • Exercises: Passive therapy, isometric exercises focused on middle deltoid.
  • Goal: 80º passive flexion, 45º abduction, 5 N of abduction force STRENGTHENING STAGE
  • Aim: Enhance scapulohumeral rhythm and strength rotator cura
  • Exercises: Active-assisted therapy, isotonic exercises between 45-90º of forward flexión and abduction with dumbbells and isometric exercises focused on internal and external rotation.
  • Goal: 100º passive flexion, 90º lateral abduction, 10 N of abduction force INTENSIVE STAGE
  • Aim: Improve motor control and increase cross-sectional muscular área
  • Exercises: Rowe with resistance band, wall push ups, lateral elevation with dumbbles, active external and internal rotation.
  • Goal: 15 N of abduction force FUNCTIONAL STAGE
  • Aim: Develope daily life activities
  • Exercises: Overhead tasks, rowe with Kettlebell, internal and external rotations with resistance bands
  • Goal: 20 N of abduction force

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
American Shoulder and Elbow Surgeons Scale (ASES) - Functionality.
Time Frame: BASELINE, 12 WEEKS, 24 WEEKS

This tool is used to evaluate functionality and shoulder-related problems. This scale contains demographic data, medical evaluation, and self-reported outcomes, with a visual analog scale (VAS) to report pain, and 10 items regarding daily life activities.

The score is calculated: [(10 - score obtained in VAS) x 5] + (5/3 x score obtained in daily life activities)]. The worst result is 0 points and the best one is 100 points.
BASELINE, 12 WEEKS, 24 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
Ultrasound image - Muscle thickness in centimeters.
Time Frame: BASELINE, 12 WEEKS, 24 WEEKS
To measure the thickness of lateral deltoid muscle at rest, at maximum contraction, and fatigued, being able to compare the muscle mass variation between presurgical and postsurgical situation, and the effect of the intervention in this variable.
BASELINE, 12 WEEKS, 24 WEEKS
Inertial sensors - Linear acceleration and angular velocity
Time Frame: BASELINE, 12 WEEKS, 24 WEEKS
To assess kinematics variables such as angular velocity and linear acceleration during flexion, abduction and scaption, to evaluate the scapulohumeral rhythm and the tridimensional scapula motion.
BASELINE, 12 WEEKS, 24 WEEKS
Dynamometer - Strength in Newtons.
Time Frame: BASELINE, 12 WEEKS, 24 WEEKS
To measure strength, time to peak, rate of force development, and muscle power of the lateral deltoid.
BASELINE, 12 WEEKS, 24 WEEKS
Goniometer - Range of motion in degrees.
Time Frame: BASELINE, 12 WEEKS, 24 WEEKS
To measure the range of motion, both passive and active, in flexion, abduction, external rotation and internal rotation.
BASELINE, 12 WEEKS, 24 WEEKS
Constant-Murley Score (CS) - Functionality
Time Frame: BASELINE, 12 WEEKS, 24 WEEKS

To evaluate functional status of the shoulder. The scale is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion (40 points).

The total score is between 0 points (worst result) and 100 points (best result).
BASELINE, 12 WEEKS, 24 WEEKS
University of California - Los Angeles Shoulder Scale (UCLA) - Functionality.
Time Frame: BASELINE, 12 WEEKS, 24 WEEKS

To assess functional outcomes after shoulder interventions. The scale include five categories: active forward flexion (5 points), strength of forward flexion (5 points), pain (10 points), satisfaction (5 points), and function (10 points).

The total score range from 0 points (worst result) and 35 points (best result).
BASELINE, 12 WEEKS, 24 WEEKS
Simple Shoulder Test (SST) - Functionality.
Time Frame: BASELINE, 12 WEEKS, 24 WEEKS

To evaluate the ability of the affected shoulder to perform daily live activities.

The tool is based on 12 "yes" (1 point) or "no" (0 points) questions. Overall score is calculated by: [number of "yes" / number of completex items] x 100, were 0 % is the worst result, and 100% is the best result.
BASELINE, 12 WEEKS, 24 WEEKS
Physiological fatigue - high density electromyography
Time Frame: Baseline, 6 Weeks, 12 weeks, 24 weeks.
We are going to use a matrix of 64 electrodes located on middle deltoid muscle. The variables extracted will be: impulse train, motor neuron recruitment,, neural drive speed
Baseline, 6 Weeks, 12 weeks, 24 weeks.
Kinematics - Motion capture system
Time Frame: Baseline, 6 weeks, 12 weeks, 24 weeks.
We are going to record analytical movements (forward flexion, lateral abduction, scaption) and functional movements with a mobile phone camera, to analyze position, linear acceleration and angular velocity
Baseline, 6 weeks, 12 weeks, 24 weeks.

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.
University of Malaga

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 (Actual)

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.
September 1, 2025

Primary Completion (Estimated)

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.
June 1, 2026

Study Completion (Estimated)

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.
December 1, 2027

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).
April 4, 2024

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.
April 4, 2024

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.
April 10, 2024

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.
April 8, 2026

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.
April 2, 2026

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.
April 1, 2026

More Information

Terms related to this study

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.
  • REMOVE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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