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NCT Number: NCT06154889

Rehabilitation by Multifactorial Approach After a Latarjet Procedure

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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Key information

Conditions

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

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

consultations with a psychologist

Other

Consultations with a sports psychologist to decrease kinesiophobia

Conventional reeducation

Other

Conventional reeducation

Primary outcomes

  1. Western Ontario Shoulder Instability Index (WOSI)

    Time frame: 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 outcomes

  1. Shoulder subjective value

    Time frame: 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%.

  2. ability to return to work

    Time frame: 6 months

    time indication

  3. ability to return to sport

    Time frame: 6 months

    time indication

  4. Patient's pain

    Time frame: 6 months

    visual analogic scale between 0 and 10

  5. Patient's kinesiophobia

    Time frame: 6 months

    Tampa's scale : 17 questions with scored results between 1 and 4

  6. S-starts test (including psychologic evaluation)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Geert Alexander Buijze, MD

CONTACT

[email protected]

+33450330950

Sponsors and collaborators

Lead sponsor

Clinique Générale dAnnecy

Other

Registry information

Official study title

Rehabilitation by Multifactorial Approach After a Latarjet Procedure : Prospective Single-center Randomized Study (MATASI-L)

Acronym: MATASI-L

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Dec 4, 2023
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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