Contribution Of Cognitivo-Behavorial Therapy In Shoulder Apprehension

Sponsor
Centre Epaule Coude CEPCO (Other)
Overall Status
Recruiting
CT.gov ID
NCT05767957
Collaborator
Gregory Cunningham (Other), Alexandre Laedermann (Other), Benoît Borner (Other), Yannick Thilby (Other), Suzanne Gard (Other)
144
2
2
36
72
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Rehabilitation physiotherapy
  • Other: Cognitive-behavioral therapies in addition to rehabilitation physiotherapy
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
144 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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 (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Contribution Of Cognitivo-Behavorial Therapy In Treatment Of Shoulder Apprehension: A Randomized Clinical Study
Actual Study Start Date :
Jan 1, 2022
Actual Primary Completion Date :
Jan 31, 2022
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Control group

Other: Rehabilitation physiotherapy
Rehabilitation physiotherapy by physiotherapist using conventional technique alone.

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.

Outcome Measures

Primary Outcome Measures

  1. Rowe score [enrolment]

    Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts)

  2. Rowe score [6 weeks]

    Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts)

  3. Rowe score [3 months]

    Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts)

  4. Rowe score [6 months]

    Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts)

  5. Rowe score [12 months]

    Score for Shoulder Stability; 0-100 points (excellent: 90-100 pts; good: 75-89 pts; average: 51-74 pts; bad: <50 pts)

Secondary Outcome Measures

  1. Shoulder Range Of Motion: flexion [enrolment]

    unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer

  2. Shoulder Range Of Motion: flexion [3 months]

    unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer

  3. Shoulder Range Of Motion: flexion [6 months]

    unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer

  4. Shoulder Range Of Motion: flexion [12 months]

    unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer

  5. Shoulder Range Of Motion: abduction [enrolment]

    unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer

  6. Shoulder Range Of Motion: abduction [3 months]

    unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer

  7. Shoulder Range Of Motion: abduction [6 months]

    unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer

  8. Shoulder Range Of Motion: abduction [12 months]

    unit of measure: angle 0-180° degrees (worst: 0°; best: 180°); measurement tool: goniometer

  9. Shoulder Range Of Motion: external rotation [enrolment]

    unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer

  10. Shoulder Range Of Motion: external rotation [3 months]

    unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer

  11. Shoulder Range Of Motion: external rotation [6 months]

    unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer

  12. Shoulder Range Of Motion: external rotation [12 months]

    unit of measure: angle 0-90° degrees (worst: 0°; best: 90°); measurement tool: goniometer

  13. Shoulder Range Of Motion: internal rotation [enrolment]

    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)

  14. Shoulder Range Of Motion: internal rotation [3 months]

    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)

  15. Shoulder Range Of Motion: internal rotation [6 months]

    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)

  16. Shoulder Range Of Motion: internal rotation [12 months]

    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)

  17. Rotator cuff strength: anterior cuff [enrolment]

    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)

  18. Rotator cuff strength: anterior cuff [3 months]

    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)

  19. Rotator cuff strength: anterior cuff [6 months]

    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)

  20. Rotator cuff strength: anterior cuff [12 months]

    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)

  21. Rotator cuff strength: superior cuff [enrolment]

    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)

  22. Rotator cuff strength: superior cuff [3 months]

    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)

  23. Rotator cuff strength: superior cuff [6 months]

    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)

  24. Rotator cuff strength: superior cuff [12 months]

    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)

  25. Rotator cuff strength: posterior cuff [enrolment]

    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)

  26. Rotator cuff strength: posterior cuff [3 months]

    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)

  27. Rotator cuff strength: posterior cuff [6 months]

    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)

  28. Rotator cuff strength: posterior cuff [12 months]

    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)

  29. Apprehension test [enrolment]

    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)

  30. Apprehension test [3 months]

    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)

  31. Apprehension test [6 months]

    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)

  32. Apprehension test [12 months]

    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)

  33. Subjective apprehension [enrolment]

    scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome))

  34. Subjective apprehension [3 months]

    scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome))

  35. Subjective apprehension [6 months]

    scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome))

  36. Subjective apprehension [12 months]

    scale 0-10 (0: no apprehension at all (= best outcome); 10: maximal apprehension (= worst outcome))

  37. Relocation test [enrolment]

    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

  38. Relocation test [3 months]

    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

  39. Relocation test [6 months]

    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

  40. Relocation test [12 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
15 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Epaule Coude CEPCO Geneva Switzerland 1206
2 Hôpital La Tour Meyrin Switzerland 1217

Sponsors and Collaborators

  • Centre Epaule Coude CEPCO
  • Gregory Cunningham
  • Alexandre Laedermann
  • Benoît Borner
  • Yannick Thilby
  • Suzanne Gard

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Epaule Coude CEPCO
ClinicalTrials.gov Identifier:
NCT05767957
Other Study ID Numbers:
  • 2021-01912
First Posted:
Mar 14, 2023
Last Update Posted:
Mar 14, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 14, 2023