An interventional study of Rehabilitation physiotherapy and Cognitive-behavioral therapies in addition to rehabilitation physiotherapy in Shoulder Dislocation and Shoulder Instability, sponsored by Centre Epaule Coude CEPCO. Status unknown at 2 sites in Switzerland. Open to participants aged 15 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-03-14.
Sponsored by Centre Epaule Coude CEPCO · Not applicable, Interventional, and Treatment
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.
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.
103 studies on the registry are indexed under Shoulder Dislocation; 23 are open to participants now.
This study's planned enrollment of 144 is above the median of 60 across 70 interventional studies indexed under Shoulder Dislocation.
Browse Shoulder Dislocation studies →This is the only study on the registry with Centre Epaule Coude CEPCO as lead sponsor.
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Exclusion Criteria:
Other: Rehabilitation physiotherapy
Other: Cognitive-behavioral therapies in addition to rehabilitation physiotherapy
Rehabilitation physiotherapy by physiotherapist using conventional technique alone.
Rehabilitation physiotherapy by physiotherapist according to conventional technique, with the addition of techniques from cognitive-behavioral therapies.
Rowe score
Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: \<50 pts)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 12 months
Shoulder Range Of Motion: flexion
unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer
Time frame: enrolment
Shoulder Range Of Motion: flexion
unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer
Time frame: 3 months
Shoulder Range Of Motion: flexion
unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer
Time frame: 6 months
Shoulder Range Of Motion: flexion
unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer
Time frame: 12 months
Shoulder Range Of Motion: abduction
unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer
Time frame: enrolment
Shoulder Range Of Motion: abduction
unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer
Time frame: 3 months
Shoulder Range Of Motion: abduction
unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer
Time frame: 6 months
Shoulder Range Of Motion: abduction
unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer
Time frame: 12 months
Shoulder Range Of Motion: external rotation
unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer
Time frame: enrolment
Shoulder Range Of Motion: external rotation
unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer
Time frame: 3 months
Shoulder Range Of Motion: external rotation
unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer
Time frame: 6 months
Shoulder Range Of Motion: external rotation
unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 12 months
Subjective apprehension
scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome))
Time frame: enrolment
Subjective apprehension
scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome))
Time frame: 3 months
Subjective apprehension
scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome))
Time frame: 6 months
Subjective apprehension
scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome))
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months
Plan to share: No
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