Contribution Of Cognitivo-Behavorial Therapy In Shoulder Apprehension

Shoulder Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05767957
• Other study ID #: 2021-01912
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2023
• Source: Centre Epaule Coude CEPCO
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: December 31, 2024
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Dislocation
• Shoulder Instability

Intervention

Other:
• Rehabilitation physiotherapy
Rehabilitation physiotherapy by physiotherapist using conventional technique alone.
• Cognitive-behavioral therapies in addition to rehabilitation physiotherapy
Rehabilitation physiotherapy by physiotherapist according to conventional technique, with the addition of techniques from cognitive-behavioral therapies.

Locations

Country	Name	City	State
Switzerland	Centre Epaule Coude CEPCO	Geneva
Switzerland	Hôpital La Tour	Meyrin

Sponsors (6)

Lead Sponsor	Collaborator
Centre Epaule Coude CEPCO	Alexandre Laedermann, Benoît Borner, Gregory Cunningham, Suzanne Gard, Yannick Thilby

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Shoulder Range Of Motion: flexion	unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer	enrolment
Secondary	Shoulder Range Of Motion: flexion	unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer	3 months
Secondary	Shoulder Range Of Motion: flexion	unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer	6 months
Secondary	Shoulder Range Of Motion: flexion	unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer	12 months
Secondary	Shoulder Range Of Motion: abduction	unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer	enrolment
Secondary	Shoulder Range Of Motion: abduction	unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer	3 months
Secondary	Shoulder Range Of Motion: abduction	unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer	6 months
Secondary	Shoulder Range Of Motion: abduction	unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer	12 months
Secondary	Shoulder Range Of Motion: external rotation	unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer	enrolment
Secondary	Shoulder Range Of Motion: external rotation	unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer	3 months
Secondary	Shoulder Range Of Motion: external rotation	unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer	6 months
Secondary	Shoulder Range Of Motion: external rotation	unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Subjective apprehension	scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome))	enrolment
Secondary	Subjective apprehension	scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome))	3 months
Secondary	Subjective apprehension	scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome))	6 months
Secondary	Subjective apprehension	scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome))	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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