Clinical trial NCT05767957: Contribution Of Cognitivo-Behavorial Therapy In Shoulder Apprehension
Official title: The Contribution Of Cognitivo-Behavorial Therapy In Treatment Of Shoulder Apprehension: A Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Shoulder Dislocation
Shoulder Instability
Lead sponsor: Centre Epaule Coude CEPCO
Sponsor class: OTHER
Collaborators: name: Gregory Cunningham
name: Alexandre Laedermann
name: Benoît Borner
name: Yannick Thilby
name: Suzanne Gard
First posted: 2023-03-14
Enrollment: 144
Sex: ALL
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Rowe score
timeFrame: enrolment
measure: Rowe score
timeFrame: 6 weeks
measure: Rowe score
timeFrame: 3 months
measure: Rowe score
timeFrame: 6 months
measure: Rowe score
timeFrame: 12 months
Secondary outcomes:
measure: Shoulder Range Of Motion: flexion
timeFrame: enrolment
measure: Shoulder Range Of Motion: flexion
timeFrame: 3 months
measure: Shoulder Range Of Motion: flexion
timeFrame: 6 months
measure: Shoulder Range Of Motion: flexion
timeFrame: 12 months
measure: Shoulder Range Of Motion: abduction
timeFrame: enrolment
measure: Shoulder Range Of Motion: abduction
timeFrame: 3 months
measure: Shoulder Range Of Motion: abduction
timeFrame: 6 months
measure: Shoulder Range Of Motion: abduction
timeFrame: 12 months
measure: Shoulder Range Of Motion: external rotation
timeFrame: enrolment
measure: Shoulder Range Of Motion: external rotation
timeFrame: 3 months
measure: Shoulder Range Of Motion: external rotation
timeFrame: 6 months
measure: Shoulder Range Of Motion: external rotation
timeFrame: 12 months
measure: Shoulder Range Of Motion: internal rotation
timeFrame: enrolment
measure: Shoulder Range Of Motion: internal rotation
timeFrame: 3 months
measure: Shoulder Range Of Motion: internal rotation
timeFrame: 6 months
measure: Shoulder Range Of Motion: internal rotation
timeFrame: 12 months
measure: Rotator cuff strength: anterior cuff
timeFrame: enrolment
measure: Rotator cuff strength: anterior cuff
timeFrame: 3 months
measure: Rotator cuff strength: anterior cuff
timeFrame: 6 months
measure: Rotator cuff strength: anterior cuff
timeFrame: 12 months
measure: Rotator cuff strength: superior cuff
timeFrame: enrolment
measure: Rotator cuff strength: superior cuff
timeFrame: 3 months
measure: Rotator cuff strength: superior cuff
timeFrame: 6 months
measure: Rotator cuff strength: superior cuff
timeFrame: 12 months
measure: Rotator cuff strength: posterior cuff
timeFrame: enrolment
measure: Rotator cuff strength: posterior cuff
timeFrame: 3 months
measure: Rotator cuff strength: posterior cuff
timeFrame: 6 months
measure: Rotator cuff strength: posterior cuff
timeFrame: 12 months
measure: Apprehension test
timeFrame: enrolment
measure: Apprehension test
timeFrame: 3 months
measure: Apprehension test
timeFrame: 6 months
measure: Apprehension test
timeFrame: 12 months
measure: Subjective apprehension
timeFrame: enrolment
measure: Subjective apprehension
timeFrame: 3 months
measure: Subjective apprehension
timeFrame: 6 months
measure: Subjective apprehension
timeFrame: 12 months
measure: Relocation test
timeFrame: enrolment
measure: Relocation test
timeFrame: 3 months
measure: Relocation test
timeFrame: 6 months
measure: Relocation test
timeFrame: 12 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Centre Epaule Coude CEPCO
city: Meyrin
country: Switzerland
facility: Hôpital La Tour
Study officials:
References: