Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-25 @ 4:16 PM
Study NCT ID:
NCT05767957
Status:
UNKNOWN
Last Update Posted:
2023-03-14
First Post:
2022-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Contribution Of Cognitivo-Behavorial Therapy In Shoulder Apprehension
Sponsor:
Centre Epaule Coude CEPCO
Organization:
Study Overview
Official Title:
The Contribution Of Cognitivo-Behavorial Therapy In Treatment Of Shoulder Apprehension: A Randomized Clinical Study
Status:
UNKNOWN
Status Verified Date:
2023-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: