Rehabilitation by Multifactorial Approach After a Latarjet Procedure (MATASI-L)

Rehabilitation by Multifactorial Approach After a Latarjet Procedure : Prospective Single-center Randomized Study (MATASI-L)

Kinesiophobia (fear of physical movement) is common after a previous shoulder dislocation and persists after one year, regardless of the occurrence of a recurrence. This kinesiophobia is associated with a lower level of physical activity and a lower return to sport. Increased kinesiophobia, combined with other psychological factors such as depression and fear of re-injury in patients with shoulder instability, results in poor outcomes after treatment. Given that there is currently no postoperative protocol that takes this psychological component into account, a new rehabilitation protocol focused on reducing kinesiophobia was recently designed as part of an international consensus study based on the method Delphi. This protocol includes a core set of evidence-based interventions aimed at regaining functional stability of the shoulder and reducing fear of recurrent dislocation and kinesiophobia. The goal of this study is to determine if we can reduce kinesiophobia in patients who have undergone stabilization surgery for anterior shoulder instability using this new rehabilitation protocol.

Study Overview

• Status: Recruiting
• Conditions: Dislocation Shoulder
• Intervention / Treatment: Other: Conventional reeducation; Other: consultations with a psychologist

• Study Type: Interventional
• Enrollment (Estimated): 52
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Geert Alexander Buijze, MD; Phone Number: +33450330950; Email: gabuijze@hotmail.com

Study Locations

• France
  • Annecy, France, 74000
    • Recruiting
    • Clinique Générale d'Annecy
    • Contact: Alexandre Coste; Phone Number: +336 40 98 05 51; Email: acoste@vivalto-sante.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Primary or recurrent traumatic anterior dislocation of the shoulder
2. Indication of abutment according to Latarjet (arthroscopic or open sky)
3. Age: 18-67 years
4. Understanding of the French language spoken and written
5. Written informed consent (in accordance with to ICH-GCP guidelines)

Exclusion Criteria:

1. Posterior or multidirectional instability of the shoulder (Beighton score >5)
2. Age <18 or >67 years.
3. Patients with additional rotator cuff tear.
4. Patients with a history of surgery on either shoulder.
5. Patients with connective tissue disorders (eg Ehler-Danlos).
6. Patients with (current) anxiety disorders or using anxiolytic medications (eg, antipsychotics) (criterion based on patient record/indications).
7. Patients with neurological disorders or systemic disease.
8. Patients with inflammatory disease, rheumatoid arthritis or active malignancy.
9. Patients previously hospitalized for shoulder pain
10. Patients with upper tubercle fracture
11. Patients with motor neurological deficit
12. Pregnant or breastfeeding patient
13. Patient protected under protective measure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Convention readaptation protocol; Patients have a conventional re-education after surgery for anterior shoulder dislocation (Latarjet procedure)	Other: Conventional reeducation; Conventional reeducation
Experimental: Readaptation protocol with psychologic intervention; Patient have a conventional re-education after surgery for anterior shoulder dislocation (Latarjet procedure) with addition of 4 consultations with a sports psychologist	Other: consultations with a psychologist; Consultations with a sports psychologist to decrease kinesiophobia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Western Ontario Shoulder Instability Index (WOSI)	self-evaluating shoulder instability quality of life score : 21 items. The patient is asked to grade the function of a specific item on a horizontal visual analog scale from 0 to 100 mm. Each question results in a number between 0 and 100 and the total score may be presented as a number between 0 and 2,100 points (where 0 represents no deficit and 2,100 the worst)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder subjective value	subjective evaluation by the patient of shoulder function, expressed as a percentage of a normal shoulder. This score ranges from 0 to 100%.	6 months
ability to return to work	time indication	6 months
ability to return to sport	time indication	6 months
Patient's pain	visual analogic scale between 0 and 10	6 months
Patient's kinesiophobia	Tampa's scale : 17 questions with scored results between 1 and 4	6 months
S-starts test (including psychologic evaluation)	Composite score : Shoulder Instability-Return to Sport after Injury questionnaire (12 items each assessed on a scale from 0 to 10) quantifying the psychological readiness of athletes to return to sport following shoulder instability through evaluating emotions, confidence in performance, and perceived risk; 4 physical performance tests; Maximal Isometric Strength of Glenohumeral Rotator Muscles; Y Balance Test for Upper Extremity; Modified Closed Kinetic Chain Upper Extremity Stability Test; Unilateral Seated Shot Put Test	6 months

Collaborators and Investigators

• Sponsor: Clinique Générale dAnnecy
• Investigators: Principal Investigator: Geert Alexander Buijze, MD, Clinique Générale d'Annecy

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2023
• Primary Completion (Estimated): November 30, 2024
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: November 21, 2023
• First Submitted That Met QC Criteria: November 30, 2023
• First Posted (Actual): December 4, 2023

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: kinesiophobia; shoulder instability; Latarjet; apprehension
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: 2023-A02057-38

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