An interventional study of MAT and CABRR in Shoulder Instability, Shoulder Dislocation or Subluxation and Fear of Movement, sponsored by Spaarne Gasthuis. Not yet recruiting. Open to participants aged 18 Years to 67 Years. Per ClinicalTrials.gov, last updated 2023-12-05.
Sponsored by Spaarne Gasthuis · Not applicable, Interventional, and Treatment
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.
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.
105 studies on the registry are indexed under Shoulder Dislocation; 22 are open to participants now.
This study's planned enrollment of 100 is above the median of 60 across 71 interventional studies indexed under Shoulder Dislocation.
Browse Shoulder Dislocation studies →Spaarne Gasthuis is the lead sponsor of 11 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Other: MAT
The original guidelines which most physiotherapists use throughout the rehabilitation of their patients following ABR is the ASSET guideline \[2\].
Other: CABRR
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
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.
Shoulder Instability Return to Sport Index (SIRSI)
Patient reported outcome measure to assess psychological readiness to return to sport in patients with shoulder instability
Time frame: 26 weeks postoperative
Oxford Shoulder Instability Score (OSIS)
Patient reported shoulder function between MAT and CABRR
Time frame: 26 and 52 weeks postoperative
Shoulder function, measured by Subjective Shoulder value (SSV)
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)
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)
Patient reported outcome measure to assess the degree of kinesiophobia
Time frame: baseline, 26 and 52 weeks postoperative
World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF)
Patient reported outcome measure to assess the self reported quality of life
Time frame: baseline, 26 and 52 weeks postoperative
Level of shoulder pain measured by Visual Analogue Scale (VAS)
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
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
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
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
The number of physiotherapy and orthopedic surgeon visits
Time frame: From start to end of treatment
Task-based brain activity, measured in voxels
Analysis using functional Magnetic Resonance Imaging (fMRI) to determine functional cerebral changes after treatment
Time frame: baseline and 26 weeks postoperative
No study locations are listed for this record.
Plan to share: No
Start is estimated for Jan 2024; primary completion for Dec 2026, 35 months later.
Of 39 non-industry interventional studies with no phase under Shoulder Dislocation, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 39. This study's planned 35 months is above that.
Counting every sponsor, half of 39 studies reached it within 22 months; a quarter within 11 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Spaarne Gasthuis