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Clinical Trials/NCT05767957
NCT05767957
Recruiting
Not Applicable

The Contribution Of Cognitivo-Behavorial Therapy In Treatment Of Shoulder Apprehension: A Randomized Clinical Study

Centre Epaule Coude CEPCO2 sites in 1 country144 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Shoulder Dislocation
Sponsor
Centre Epaule Coude CEPCO
Enrollment
144
Locations
2
Primary Endpoint
Rowe score
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Randomized controlled double-blind study aimed at studying the contribution of cognitive-behavioral therapy in the treatment of shoulder apprehension. Comparison of 2 physiotherapy techniques in the context of shoulder instability.

Control group: rehabilitation physiotherapy by physiotherapist using conventional technique alone.

Intervention group: rehabilitation physiotherapy by physiotherapist according to conventional technique, with the addition of techniques from cognitive-behavioral therapies.

Detailed Description

Traumatic anterior instability of the shoulder is one of the most frequent lesions of the shoulder, the majority of cases of which occur in adolescents, with a risk of recurrence close to 90% if it occurs before the age of 20 years. It can be treated conservatively or surgically. Stabilizing surgery of the glenohumeral joint offers satisfactory results for people suffering from shoulder instability. Like subjects treated conservatively, patients undergoing stabilizing surgery remain apprehensive after the operation in 2 to 51% of cases. Currently, no rehabilitation program has demonstrated superior effectiveness, during instability treated conservatively or during postoperative rehabilitation. Recent studies have shown that cortical reorganization takes place, especially in areas of fear and anxiety. Faced with the need to develop physiotherapeutic management in post-traumatic unstable shoulder, this study aims to evaluate the contribution of cognitive-behavioral therapy, by including a neuropsychological axis in the rehabilitation of patients. This study is randomized and controlled, multicenter, including 144 patients suffering from apprehension of the shoulder, divided into two treatment groups. Both groups will receive a conventional physiotherapy protocol including individual sessions and home exercises. The physiotherapists in the intervention group will also have received training in the use of techniques from Cognitive-Behavioral Therapies. Data will be collected before the introduction of physiotherapy, after 6, 12, 24 and 52 weeks of treatment. In the event of surgery, the data will also be collected preoperatively. The primary outcome is apprehension measured by the Rowe score. The secondary outcomes are apprehension measured by the apprehension and relocation tests, and the Tampa Scale for Kinesiophobia, as well as shoulder function, measured by the Simple Shoulder Test and the Subjective Shoulder Value.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
December 31, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centre Epaule Coude CEPCO
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • positive apprehension test;
  • traumatic anterior dislocation of the glenohumeral joint requiring or not surgical stabilization according to Bankart or Latarjet;
  • good oral and written comprehension of French;
  • age between 15 and 45 years old.

Exclusion Criteria

  • associated tendon injury requiring surgical treatment;
  • fracture other than Bankart fracture;
  • multidirectional instability (MDI);
  • peripheral neurological lesion in the upper limb;
  • central neurological lesion;
  • diagnosed psychosis, depression or epilepsy.

Outcomes

Primary Outcomes

Rowe score

Time Frame: 12 months

Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: \<50 pts)

Secondary Outcomes

  • Shoulder Range Of Motion: flexion(12 months)
  • Shoulder Range Of Motion: abduction(12 months)
  • Shoulder Range Of Motion: external rotation(12 months)
  • Shoulder Range Of Motion: internal rotation(12 months)
  • Rotator cuff strength: anterior cuff(12 months)
  • Rotator cuff strength: superior cuff(12 months)
  • Rotator cuff strength: posterior cuff(12 months)
  • Apprehension test(12 months)
  • Subjective apprehension(12 months)
  • Relocation test(12 months)

Study Sites (2)

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