Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis

Prosthesis User Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06357143
• Other study ID #: REMOVE
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2025
• Est. completion date: December 2027

Study information

• Verified date: May 2024
• Source: University of Malaga
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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 three times, at baseline, at 12 weeks and at 24 weeks to assess psychometric and laboratory outcomes.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prosthesis User
• Shoulder Fractures

Intervention

Other:
• REMOVE
Early multimodal physiotherapy program focused on therapeutic exercise
• CONTROL
Standard care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaga

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	American Shoulder and Elbow Surgeons Scale (ASES) - Functionality.	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	Ultrasound image - Muscle thickness in centimeters.	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
Secondary	Inertial sensors - Linear acceleration and angular velocity	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
Secondary	Dynamometer - Strength in Newtons.	To measure strength, time to peak, rate of force development, and muscle power of the lateral deltoid.	BASELINE, 12 WEEKS, 24 WEEKS
Secondary	Goniometer - Range of motion in degrees.	To measure the range of motion, both passive and active, in flexion, abduction, external rotation and internal rotation.	BASELINE, 12 WEEKS, 24 WEEKS
Secondary	Constant-Murley Score (CS) - Functionality	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
Secondary	University of California - Los Angeles Shoulder Scale (UCLA) - Functionality.	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
Secondary	Simple Shoulder Test (SST) - Functionality.	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