Rehabilitation by Multifactorial Approach After a Latarjet Procedure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-29

Study Completion Date

2026-05-30

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.

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Detailed Description

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Conditions

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Dislocation Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Convention readaptation protocol

Patients have a conventional re-education after surgery for anterior shoulder dislocation (Latarjet procedure)

Group Type ACTIVE_COMPARATOR

Conventional reeducation

Intervention Type OTHER

Conventional reeducation

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

Group Type EXPERIMENTAL

consultations with a psychologist

Intervention Type OTHER

Consultations with a sports psychologist to decrease kinesiophobia

Interventions

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consultations with a psychologist

Consultations with a sports psychologist to decrease kinesiophobia

Intervention Type OTHER

Conventional reeducation

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

67 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No