Rehabilitation by Multifactorial Approach After a Latarjet Procedure

NCT06154889 | Recruiting

• 1 other identifier: 2023-A02057-38
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Dislocation Shoulder

Keywords

shoulder instability; kinesiophobia; Latarjet; apprehension

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Shoulder subjective value

  6 months

• ability to return to work

  6 months

• ability to return to sport

  6 months

• Patient's pain

  6 months

• Patient's kinesiophobia

  6 months

Study Arms (2)

Convention readaptation protocol

ACTIVE COMPARATOR

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

Other: Conventional reeducation

Readaptation protocol with psychologic intervention

EXPERIMENTAL

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

Interventions

consultations with a psychologist OTHER

Consultations with a sports psychologist to decrease kinesiophobia

Readaptation protocol with psychologic intervention

Conventional reeducation OTHER

Conventional reeducation

Convention readaptation protocol

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Générale dAnnecy: lead

Study Sites (1)

Clinique Générale d'Annecy

Annecy, 74000, France

RECRUITING

Related Publications (1)

• Soares MN, Shirinskiy IJ, Schachner J, Matasi Collaborator Group MCG, Macken AA, Kling A, Lafosse T, van den Bekerom MPJ, Buijze GA. Multifactorial approach training for anterior shoulder instability after a Latarjet procedure: protocol for a randomised controlled trial. BMJ Open. 2026 Jan 21;16(1):e109378. doi: 10.1136/bmjopen-2025-109378.

  PMID: 41565337 DERIVED

MeSH Terms

Conditions

Shoulder Dislocation; Kinesiophobia

Interventions

Referral and Consultation

Condition Hierarchy (Ancestors)

Joint Dislocations; Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries; Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Professional Practice; Organization and Administration; Health Services Administration

Study Officials

• Geert Alexander Buijze, MD

  Clinique Générale d'Annecy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Geert Alexander Buijze, MD

CONTACT

+33450330950; gabuijze@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2023
• First Posted: December 4, 2023
• Study Start: November 29, 2023
• Primary Completion: November 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)