Contribution Of Cognitivo-Behavorial Therapy In Shoulder Apprehension

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Shoulder Dislocation, Shoulder Instability

Intervention / Treatment
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* Other: Rehabilitation physiotherapy
* Other: Cognitive-behavioral therapies in addition to rehabilitation physiotherapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control group<br> | Other: Rehabilitation physiotherapy<br>* Rehabilitation physiotherapy by physiotherapist using conventional technique alone.<br>|
| Experimental: Intervention group<br> | Other: Cognitive-behavioral therapies in addition to rehabilitation physiotherapy<br>* Rehabilitation physiotherapy by physiotherapist according to conventional technique, with the addition of techniques from cognitive-behavioral therapies.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rowe score | Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts) | enrolment | 
| Rowe score | Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts) | 6 weeks | 
| Rowe score | Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts) | 3 months | 
| Rowe score | Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts) | 6 months | 
| Rowe score | Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Range Of Motion: flexion | unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer | enrolment | 
| Shoulder Range Of Motion: flexion | unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer | 3 months | 
| Shoulder Range Of Motion: flexion | unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer | 6 months | 
| Shoulder Range Of Motion: flexion | unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer | 12 months | 
| Shoulder Range Of Motion: abduction | unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer | enrolment | 
| Shoulder Range Of Motion: abduction | unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer | 3 months | 
| Shoulder Range Of Motion: abduction | unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer | 6 months | 
| Shoulder Range Of Motion: abduction | unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer | 12 months | 
| Shoulder Range Of Motion: external rotation | unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer | enrolment | 
| Shoulder Range Of Motion: external rotation | unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer | 3 months | 
| Shoulder Range Of Motion: external rotation | unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer | 6 months | 
| Shoulder Range Of Motion: external rotation | unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer | 12 months | 
| Shoulder Range Of Motion: internal rotation | unit of measure: height of the position of the hand in the back according to anatomical landmarks; 1- lateral thigh, 2- buttock, 3- lumbosacral junction, 4- waist (L3 vertebra), 5- T12 vertebra, 6- interscapular (T7 vertebra) (worst: 1; best: 6) | enrolment | 
| Shoulder Range Of Motion: internal rotation | unit of measure: height of the position of the hand in the back according to anatomical landmarks; 1- lateral thigh, 2- buttock, 3- lumbosacral junction, 4- waist (L3 vertebra), 5- T12 vertebra, 6- interscapular (T7 vertebra) (worst: 1; best: 6) | 3 months | 
| Shoulder Range Of Motion: internal rotation | unit of measure: height of the position of the hand in the back according to anatomical landmarks; 1- lateral thigh, 2- buttock, 3- lumbosacral junction, 4- waist (L3 vertebra), 5- T12 vertebra, 6- interscapular (T7 vertebra) (worst: 1; best: 6) | 6 months | 
| Shoulder Range Of Motion: internal rotation | unit of measure: height of the position of the hand in the back according to anatomical landmarks; 1- lateral thigh, 2- buttock, 3- lumbosacral junction, 4- waist (L3 vertebra), 5- T12 vertebra, 6- interscapular (T7 vertebra) (worst: 1; best: 6) | 12 months | 
| Rotator cuff strength: anterior cuff | scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength) | enrolment | 
| Rotator cuff strength: anterior cuff | scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength) | 3 months | 
| Rotator cuff strength: anterior cuff | scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength) | 6 months | 
| Rotator cuff strength: anterior cuff | scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength) | 12 months | 
| Rotator cuff strength: superior cuff | scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength) | enrolment | 
| Rotator cuff strength: superior cuff | scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength) | 3 months | 
| Rotator cuff strength: superior cuff | scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength) | 6 months | 
| Rotator cuff strength: superior cuff | scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength) | 12 months | 
| Rotator cuff strength: posterior cuff | scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength) | enrolment | 
| Rotator cuff strength: posterior cuff | scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength) | 3 months | 
| Rotator cuff strength: posterior cuff | scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength) | 6 months | 
| Rotator cuff strength: posterior cuff | scale 0-5 (0/5: no contraction ; 1/5: muscle contraction visible, no motion; 2/5: motion with gravity eliminated; 3/5: motion against gravity; 4/5: motion against moderate resistance; 5/5: normal muscle strength) | 12 months | 
| Apprehension test | examiner flexes the patient's elbow to 90° and abducts shoulder to 90°, then slowly externally rotates the patient's shoulder; the patient demonstrates apprehension during shoulder external rotation at different positions as follow: 1- early, 2- cocked position, 3- forced external rotation, 4- forced external rotation with posterior-anterior pressure (worst: 1; best: 4) | enrolment | 
| Apprehension test | examiner flexes the patient's elbow to 90° and abducts shoulder to 90°, then slowly externally rotates the patient's shoulder; the patient demonstrates apprehension during shoulder external rotation at different positions as follow: 1- early, 2- cocked position, 3- forced external rotation, 4- forced external rotation with posterior-anterior pressure (worst: 1; best: 4) | 3 months | 
| Apprehension test | examiner flexes the patient's elbow to 90° and abducts shoulder to 90°, then slowly externally rotates the patient's shoulder; the patient demonstrates apprehension during shoulder external rotation at different positions as follow: 1- early, 2- cocked position, 3- forced external rotation, 4- forced external rotation with posterior-anterior pressure (worst: 1; best: 4) | 6 months | 
| Apprehension test | examiner flexes the patient's elbow to 90° and abducts shoulder to 90°, then slowly externally rotates the patient's shoulder; the patient demonstrates apprehension during shoulder external rotation at different positions as follow: 1- early, 2- cocked position, 3- forced external rotation, 4- forced external rotation with posterior-anterior pressure (worst: 1; best: 4) | 12 months | 
| Subjective apprehension | scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome)) | enrolment | 
| Subjective apprehension | scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome)) | 3 months | 
| Subjective apprehension | scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome)) | 6 months | 
| Subjective apprehension | scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome)) | 12 months | 
| Relocation test | positive/negative; patient's shoulder is brought into 90° of abduction and maximal external rotation until the patient feels apprehension; examiner gives an antero-posterior (AP) directed pressure at the humeral head; test positive if fear of luxation is reduced after the AP pressure is applied | enrolment | 
| Relocation test | positive/negative; patient's shoulder is brought into 90° of abduction and maximal external rotation until the patient feels apprehension; examiner gives an antero-posterior (AP) directed pressure at the humeral head; test positive if fear of luxation is reduced after the AP pressure is applied | 3 months | 
| Relocation test | positive/negative; patient's shoulder is brought into 90° of abduction and maximal external rotation until the patient feels apprehension; examiner gives an antero-posterior (AP) directed pressure at the humeral head; test positive if fear of luxation is reduced after the AP pressure is applied | 6 months | 
| Relocation test | positive/negative; patient's shoulder is brought into 90° of abduction and maximal external rotation until the patient feels apprehension; examiner gives an antero-posterior (AP) directed pressure at the humeral head; test positive if fear of luxation is reduced after the AP pressure is applied | 12 months |