Rehabilitation by Multifactorial Approach After a Latarjet Procedure

Study Overview
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Brief Summary
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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.

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

Conditions
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Dislocation Shoulder

Intervention / Treatment
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* Other: consultations with a psychologist
* Other: Conventional reeducation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary or recurrent traumatic anterior dislocation of the shoulder Indication of abutment according to Latarjet (arthroscopic or open sky) Age: 18-67 years Understanding of the French language spoken and written Written informed consent (in accordance with to ICH-GCP guidelines) Exclusion Criteria: Posterior or multidirectional instability of the shoulder (Beighton score >5) Age <18 or >67 years. Patients with additional rotator cuff tear. Patients with a history of surgery on either shoulder. Patients with connective tissue disorders (eg Ehler-Danlos). Patients with (current) anxiety disorders or using anxiolytic medications (eg, antipsychotics) (criterion based on patient record/indications). Patients with neurological disorders or systemic disease. Patients with inflammatory disease, rheumatoid arthritis or active malignancy. Patients previously hospitalized for shoulder pain Patients with upper tubercle fracture Patients with motor neurological deficit Pregnant or breastfeeding patient Patient protected under protective measure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Convention readaptation protocol<br>Patients have a conventional re-education after surgery for anterior shoulder dislocation (Latarjet procedure) | Other: Conventional reeducation<br>* Conventional reeducation<br>|
| Experimental: Readaptation protocol with psychologic intervention<br>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<br>* Consultations with a sports psychologist to decrease kinesiophobia<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder instability, kinesiophobia, Latarjet, apprehension