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Rehabilitation by Multifactorial Approach After a Latarjet Procedure (MATASI-L)

C

Clinique Générale dAnnecy

Status

Enrolling

Conditions

Dislocation Shoulder

Treatments

Other: consultations with a psychologist
Other: Conventional reeducation

Study type

Interventional

Funder types

Other

Identifiers

NCT06154889
2023-A02057-38

Details and patient eligibility

About

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.

Enrollment

52 estimated patients

Sex

All

Ages

18 to 67 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

52 participants in 2 patient groups

Convention readaptation protocol
Active Comparator group
Description:
Patients have a conventional re-education after surgery for anterior shoulder dislocation (Latarjet procedure)
Treatment:
Other: Conventional reeducation
Readaptation protocol with psychologic intervention
Experimental group
Description:
Patient have a conventional re-education after surgery for anterior shoulder dislocation (Latarjet procedure) with addition of 4 consultations with a sports psychologist
Treatment:
Other: consultations with a psychologist

Trial contacts and locations

1

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Central trial contact

Geert Alexander Buijze, MD

Data sourced from clinicaltrials.gov

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