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Recruiting Not applicable

Rehabilitation by Multifactorial Approach After a Latarjet Procedure

NCT06154889 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-11-29
Last updated
2026-04-06

Condition(s) studied

Dislocation Shoulder

Investigational drug(s) / intervention(s)

consultations with a psychologistConventional reeducation

consultations with a psychologist: Consultations with a sports psychologist to decrease kinesiophobia

Conventional reeducation: Conventional reeducation

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
67 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • 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)

Trial sites (1)

FacilityCityRegionStatus
Clinique Générale d'Annecy Annecy France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06154889 on ClinicalTrials.gov ↗ ← All trials in France