Contribution Of Cognitivo-Behavorial Therapy In Shoulder Apprehension

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

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.

Study Overview

• Status: Recruiting
• Conditions: Shoulder Instability; Shoulder Dislocation
• Intervention / Treatment: Other: Rehabilitation physiotherapy; Other: Cognitive-behavioral therapies in addition to rehabilitation physiotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1206
    • Recruiting
    • Centre Epaule Coude CEPCO
    • Contact: Benoît Borner; Phone Number: +41 79 430 17 26; Email: benoit.borner@bluewin.ch
    • Sub-Investigator: Benoît Borner
    • Principal Investigator: Gregory Cunningham
  • Meyrin, Switzerland, 1217
    • Recruiting
    • Hôpital La Tour
    • Contact: Benoît Borner; Phone Number: +41 79 430 17 26; Email: benoit.borner@bluewin.ch
    • Principal Investigator: Alexandre Laedermann
    • Sub-Investigator: Yannick Thilby

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group	Other: 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.
Active Comparator: Control group	Other: Rehabilitation physiotherapy; Rehabilitation physiotherapy by physiotherapist using conventional technique alone.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre Epaule Coude CEPCO
• Collaborators: Gregory Cunningham; Alexandre Laedermann; Benoît Borner; Yannick Thilby; Suzanne Gard

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): January 31, 2022
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: July 25, 2022
• First Submitted That Met QC Criteria: March 12, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 14, 2023
• Last Update Submitted That Met QC Criteria: March 12, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: 2021-01912

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No