Rehabilitation by Multifactorial Approach After a Latarjet Procedure

Not Applicable

Recruiting

• Conditions: Dislocation Shoulder
• Interventions: Other: consultations with a psychologist; Other: Conventional reeducation

• Registration Number: NCT06154889
• Lead Sponsor: Clinique Générale dAnnecy

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-11-21
• Study Start: 2023-11-29
• Study First Submitted QC: 2023-11-30
• Study First Posted: 2023-12-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2025-11-30
• Study Completion: 2026-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 52

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Readaptation protocol with psychologic intervention	consultations with a psychologist	Patient have a conventional re-education after surgery for anterior shoulder dislocation (Latarjet procedure) with addition of 4 consultations with a sports psychologist
Convention readaptation protocol	Conventional reeducation	Patients have a conventional re-education after surgery for anterior shoulder dislocation (Latarjet procedure)

Primary Outcome Measures

Name	Time	Method
Western Ontario Shoulder Instability Index (WOSI)	6 months	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)

Secondary Outcome Measures

Name	Time	Method
Patient's kinesiophobia	6 months	Tampa's scale : 17 questions with scored results between 1 and 4
Patient's pain	6 months	visual analogic scale between 0 and 10
ability to return to work	6 months	time indication
S-starts test (including psychologic evaluation)	6 months	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
Shoulder subjective value	6 months	subjective evaluation by the patient of shoulder function, expressed as a percentage of a normal shoulder. This score ranges from 0 to 100%.
ability to return to sport	6 months	time indication

Trial Locations

Locations (1)

Clinique Générale d'Annecy; 🇫🇷 Annecy, France