Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06157229
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-05
First Post:
2023-06-20
Brief Title:
Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair
Sponsor:
Spaarne Gasthuis
Organization:
Spaarne Gasthuis
Study Overview
Official Title:
Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
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:
MATASI
Brief Summary:
This study will compare functional outcomes after an arthroscopic Bankart repair between patients that underwent conventional arthroscopic Bankart repair rehabilitation following the American Society of Shoulder and Elbow Therapists guideline and patients that underwent multifactorial approach training which focusses on decreasing kinesiophobia and fear of recurrent dislocations
The study population comprises patients who will undergo Arthroscopic Bankart Repair ABR after a traumatic anterior shoulder dislocation at Spaarne Gasthuis HaarlemHoofddorp OLVG Amsterdam Amstelland Ziekenhuis Amstelveen Gelre Ziekenhuizen Medisch Spectrum Twente or Flevoziekenhuis Almere
The study population comprises patients who will undergo Arthroscopic Bankart Repair ABR after a traumatic anterior shoulder dislocation at Spaarne Gasthuis HaarlemHoofddorp OLVG Amsterdam Amstelland Ziekenhuis Amstelveen Gelre Ziekenhuizen Medisch Spectrum Twente or Flevoziekenhuis Almere
Detailed Description:
Background Fear for recurrent dislocation is a frequently reported patient perception regarding the treatment of anterior shoulder instability and is associated with poor outcomes like decrease in quality of life and unsuccesful return to sport There is lack of standard multifactorial aftercare of shoulder instability surgery incorporating the psychological component of the experiences trauma of patients with shoulder instability Therefore a newly developed Rehabilitation Protocol REPRO aims to reduce fear for dislocation in order to increase psychological readiness to return to sport The aim of this study is to compare the effect on the psychological readiness to return to sport between our new Multifactorial Approach Training MAT and Conventional Arthroscopic Bankart Repair Rehabilitation CABRR in a single-blinded multi-center randomized controlled trial
Methods Patients aged 18-67 years with traumatic anterior shoulder instability undergoing ABR will be included Rehabilitation is started within 4 weeks following surgical treatment Patients will be randomized to either the control group A or the MAT group B Group A will receive CABRR according to the American Society of Shoulder and Elbow Therapists ASSET guidelines Group B will receive MAT following the REPRO A total of 92 patients will be included with 46 patients per study arm Patients will be followed-up for 52 weeks The primary outcome is change from baseline surgical intervention ABR in Shoulder Instability Return to Sport Index SIRSI at 26 weeks postoperatively Secondary outcomes include Oxford Shoulder Instability Score OSIS Subjective Shoulder Value SSV fear for dislocation measured with a Numeric Rating Scale NRS Tampa Scale of Kinesiophobia in patients with Shoulder Instability TSK-SI World Health Organization Quality of Life Questionnaire - BREF WHOQoL-BREF Return To Work RTW Return To Sports RTS shoulder pain measured with a NRS number of physiotherapy and outpatient clinic visits and patient satisfaction VAS At baseline and at 26 weeks postoperatively patients will undergo a task-based brain activity analysis using functional Magnetic Resonance Imaging fMRI to determine functional cerebral changes after treatment The MATASI trial is to be conducted between 2024 and 2026
Methods Patients aged 18-67 years with traumatic anterior shoulder instability undergoing ABR will be included Rehabilitation is started within 4 weeks following surgical treatment Patients will be randomized to either the control group A or the MAT group B Group A will receive CABRR according to the American Society of Shoulder and Elbow Therapists ASSET guidelines Group B will receive MAT following the REPRO A total of 92 patients will be included with 46 patients per study arm Patients will be followed-up for 52 weeks The primary outcome is change from baseline surgical intervention ABR in Shoulder Instability Return to Sport Index SIRSI at 26 weeks postoperatively Secondary outcomes include Oxford Shoulder Instability Score OSIS Subjective Shoulder Value SSV fear for dislocation measured with a Numeric Rating Scale NRS Tampa Scale of Kinesiophobia in patients with Shoulder Instability TSK-SI World Health Organization Quality of Life Questionnaire - BREF WHOQoL-BREF Return To Work RTW Return To Sports RTS shoulder pain measured with a NRS number of physiotherapy and outpatient clinic visits and patient satisfaction VAS At baseline and at 26 weeks postoperatively patients will undergo a task-based brain activity analysis using functional Magnetic Resonance Imaging fMRI to determine functional cerebral changes after treatment The MATASI trial is to be conducted between 2024 and 2026
Study Oversight
Has Oversight DMC:
None
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?:
None