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NCT Number: NCT06357143

Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis

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.

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Key information

Conditions

Shoulder Fractures Fractures, Bone Prosthesis User Shoulder Injuries Wounds and Injuries

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antonio Cuesta Vargas

Málaga, Spain

Location status: Recruiting

Location contact

Antonio Ignacio, Cuesta Vargas, PhD

CONTACT

[email protected]

952137551 ext. +34

Cuesta Vargas A Antonio Ignacio, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

REMOVE

Other

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

Control

Other

Patients will undergo standard care which consists of an initial consultation with the physiotherapist to receive some recommendations about exercises, progression and health education

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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).

  7. 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.

  8. 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

  9. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio I Cuesta-Vargas, PhD

CONTACT

[email protected]

(+34) 667 45 55 44

Sponsors and collaborators

Lead sponsor

University of Malaga

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Apr 10, 2024
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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