Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair
NCT ID: NCT06157229
Last Updated: 2023-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2024-01-01
2027-06-01
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Multifactorial Approach Training (MAT)
MAT involves an evidence-based core outcome-set of interventions aimed at both regaining functional stability of the shoulder and also diminishing fear of (recurrent) dislocation and kinesiophobia. The protocol is based on a recent international Delphi-based consensus study, initiated since no protocol yet existed focusing on this psychological component of traumatic anterior shoulder instability.
MAT
The protocol consists of four phases: 1) immobilization phase, 2) early protective phase, 3) intermediate phase and 4) late phase. The detailed guideline can be found in the following article:
Gaunt, B. W., Shaffer, M. A., Sauers, E. L., Michener, L. A., McCluskey, G. M., \& Thigpen, C. A. (2010). The American Society of Shoulder and Elbow Therapists' Consensus Rehabilitation Guideline for Arthroscopic Anterior Capsulolabral Repair of the Shoulder. Journal of Orthopaedic \& Sports Physical Therapy, 40(3), 155-168. https://doi.org/10.2519/jospt.2010.3186
Conventional Arthroscopic Bankart Repair Rehabilitation (CABRR)
The original guidelines which most physiotherapists use throughout the rehabilitation of their patients following ABR is the ASSET guideline \[2\].
CABRR
The protocol consists of four phases: 1) immobilization phase, 2) early phase, 3) intermediate phase and 4) advanced phase.
The protocol comprises education, modified cognitive behavioral therapy, neuromuscular control exercises, kinetic chain exercises, range of motion enhancing exercises, strength and conditioning exercises, and sport-specific exercises. The protocol is currently unpublished.
Interventions
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MAT
The protocol consists of four phases: 1) immobilization phase, 2) early protective phase, 3) intermediate phase and 4) late phase. The detailed guideline can be found in the following article:
Gaunt, B. W., Shaffer, M. A., Sauers, E. L., Michener, L. A., McCluskey, G. M., \& Thigpen, C. A. (2010). The American Society of Shoulder and Elbow Therapists' Consensus Rehabilitation Guideline for Arthroscopic Anterior Capsulolabral Repair of the Shoulder. Journal of Orthopaedic \& Sports Physical Therapy, 40(3), 155-168. https://doi.org/10.2519/jospt.2010.3186
CABRR
The protocol consists of four phases: 1) immobilization phase, 2) early phase, 3) intermediate phase and 4) advanced phase.
The protocol comprises education, modified cognitive behavioral therapy, neuromuscular control exercises, kinetic chain exercises, range of motion enhancing exercises, strength and conditioning exercises, and sport-specific exercises. The protocol is currently unpublished.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
67 Years
ALL
No
Sponsors
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OLVG
NETWORK
Ziekenhuis Amstelland
OTHER
Gelre Hospitals
OTHER
Medisch Spectrum Twente
OTHER
Flevoziekenhuis
OTHER
Spaarne Gasthuis
OTHER
Responsible Party
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Principal Investigators
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Arthur van Noort, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Orthopedic Surgeon and Head of Residency Program, Spaarne Gasthuis
Central Contacts
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References
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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.
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.
Other Identifiers
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reudctionapprehension
Identifier Type: -
Identifier Source: org_study_id