Clinical trial NCT06157229: Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair
Official title: Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Shoulder Instability
Shoulder Dislocation or Subluxation
Fear of Movement
Kinesiophobia
Lead sponsor: Spaarne Gasthuis
Sponsor class: OTHER
Collaborators: name: OLVG
name: Ziekenhuis Amstelland
name: Gelre Hospitals
name: Medisch Spectrum Twente
name: Flevoziekenhuis
First posted: 2023-12-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 Haarlem/Hoofddorp, 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.

Eligibility criteria: Inclusion Criteria:

* Primary or recurrent traumatic anterior shoulder dislocation (MRI-confirmed labral tear)
* Aged between 18-67 years
* Planned arthroscopic Bankart repair (ABR) surgery
* Understanding of spoken and written Dutch language
* Written informed consent (according to the ICH-GCP guidelines)
* Positive apprehension sign at physical examination

Exclusion Criteria:

* Posterior or multidirectional shoulder instability
* Presence of hyperlaxity of the upper extremity and absence of sulcus sign and \>85 degrees of external rotation with the arm at the side at physical examination
* Connective tissue disorders (e.g. Ehlers-Danlos)
* Aged \<18 or \>67 years
* Assymetry in rotator cuff strength, bilateral component ((sub)luxations on contralateral side)
* History of soft tissue repair or bone block procedure on one of both shoulders
* Current or past anxiety disorders or use of anxiety supressing drugs (e.g. anti-psychotics)
* Implantable cardioverter defibrillator (ICD) (unable to be included for functional MRI)
* Neurological disorders or systemic disease
* Loss of anteroinferior sclerotic contour of the glenoid on AP view of the shoulder
* Hill-Sachs lesion visible on external rotation radiographs
* Greater tubercle fracture

Primary outcomes:
measure: Shoulder Instability Return to Sport Index (SIRSI)
timeFrame: 26 weeks postoperative
Secondary outcomes:
measure: Oxford Shoulder Instability Score (OSIS)
timeFrame: 26 and 52 weeks postoperative
measure: Shoulder function, measured by Subjective Shoulder value (SSV)
timeFrame: baseline, 26 and 52 weeks postoperative
measure: Fear of recurrent dislocation, measured by Numeric Rating Scale (NRS)
timeFrame: baseline, 26 and 52 weeks postoperative
measure: Tampa Scale for Kinesiophobia in patients with Shoulder Instability (TSK-SI)
timeFrame: baseline, 26 and 52 weeks postoperative
measure: World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF)
timeFrame: baseline, 26 and 52 weeks postoperative
measure: Level of shoulder pain measured by Visual Analogue Scale (VAS)
timeFrame: baseline, 26 and 52 weeks postoperative
measure: Number of patients that return to work (RTW) following the surgery
timeFrame: 26 and 52 weeks postoperative
measure: Number of patients tha return to sport (RTS) following the surgery
timeFrame: 26 and 52 weeks postoperative
measure: Patient satisfaction regarding the surgical treatment and rehabilitation, measured by VAS
timeFrame: baseline, 26 weeks and 52 weeks postoperative
measure: The number of physiotherapy and orthopedic surgeon visits
timeFrame: From start to end of treatment
measure: Task-based brain activity, measured in voxels
timeFrame: baseline and 26 weeks postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Orthopedic Surgeon and Head of Residency Program, Spaarne Gasthuis
name: Arthur van Noort, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gaunt BW, Shaffer MA, Sauers EL, Michener LA, McCluskey GM, Thigpen C; American Society of Shoulder and Elbow Therapists. The American Society of Shoulder and Elbow Therapists' consensus rehabilitation guideline for arthroscopic anterior capsulolabral repair of the shoulder. J Orthop Sports Phys Ther. 2010 Mar;40(3):155-68. doi: 10.2519/jospt.2010.3186.
citation: van Iersel TP, Tutuhatunewa ED, Kaman I, Twigt BA, Vorrink SN, van den Bekerom MP, van Deurzen DF. Patient perceptions after the operative and nonoperative treatment of shoulder instability: A qualitative focus group study. Shoulder Elbow. 2023 Oct;15(5):497-504. doi: 10.1177/17585732221122363. Epub 2022 Aug 24.