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Not yet recruiting NCT06157229

Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair

No phase Interventional Shoulder Instability Shoulder Dislocation or Subluxation Fear of Movement Kinesiophobia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MAT, CABRR.
Who it may be relevant to
Registry conditions: Shoulder Instability, Shoulder Dislocation or Subluxation, Fear of Movement, Kinesiophobia. Basic parameters: 18 years — 67 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair, a Randomized Controlled Trial

Overview

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.

Interventions

  • Other 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 Ther
  • Other 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.

Primary outcome measures

  • Shoulder Instability Return to Sport Index (SIRSI) [Time frame: 26 weeks postoperative]
Secondary outcome measures (11)
  • Oxford Shoulder Instability Score (OSIS) [Time frame: 26 and 52 weeks postoperative]
  • Shoulder function, measured by Subjective Shoulder value (SSV) [Time frame: baseline, 26 and 52 weeks postoperative]
  • Fear of recurrent dislocation, measured by Numeric Rating Scale (NRS) [Time frame: baseline, 26 and 52 weeks postoperative]
  • Tampa Scale for Kinesiophobia in patients with Shoulder Instability (TSK-SI) [Time frame: baseline, 26 and 52 weeks postoperative]
  • World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF) [Time frame: baseline, 26 and 52 weeks postoperative]
  • Level of shoulder pain measured by Visual Analogue Scale (VAS) [Time frame: baseline, 26 and 52 weeks postoperative]
  • Number of patients that return to work (RTW) following the surgery [Time frame: 26 and 52 weeks postoperative]
  • Number of patients tha return to sport (RTS) following the surgery [Time frame: 26 and 52 weeks postoperative]
  • Patient satisfaction regarding the surgical treatment and rehabilitation, measured by VAS [Time frame: baseline, 26 weeks and 52 weeks postoperative]
  • The number of physiotherapy and orthopedic surgeon visits [Time frame: From start to end of treatment]
  • Task-based brain activity, measured in voxels [Time frame: baseline and 26 weeks postoperative]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • 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. PMID 20195022
  • 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. PMID 37811392

Identifiers

NCT: NCT06157229 · reudctionapprehension

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗