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

Kinesiophobia Clinical Trial

— MATASI  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06157229
• Other study ID #: reudctionapprehension
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: June 1, 2027

Study information

• Verified date: November 2023
• Source: Spaarne Gasthuis
• Contact: Madu N Soares, BSc.
• Phone: +31648164073
• Email: msoaresfilho[@]spaarnegasthuis.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: June 1, 2027
• Est. primary completion date: December 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 67 Years

Eligibility

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

Related Conditions & MeSH terms

• Fear of Movement
• Kinesiophobia
• Shoulder Dislocation
• Shoulder Instability

Intervention

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 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.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Spaarne Gasthuis	Flevoziekenhuis, Gelre Hospitals, Medisch Spectrum Twente, OLVG, Ziekenhuis Amstelland

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Instability Return to Sport Index (SIRSI)	Patient reported outcome measure to assess psychological readiness to return to sport in patients with shoulder instability	26 weeks postoperative
Secondary	Oxford Shoulder Instability Score (OSIS)	Patient reported shoulder function between MAT and CABRR	26 and 52 weeks postoperative
Secondary	Shoulder function, measured by Subjective Shoulder value (SSV)	Shoulder function, measured by Subjective Shoulder value (SSV)	baseline, 26 and 52 weeks postoperative
Secondary	Fear of recurrent dislocation, measured by Numeric Rating Scale (NRS)	Fear of recurrent dislocation, measured by Numeric Rating Scale (NRS)	baseline, 26 and 52 weeks postoperative
Secondary	Tampa Scale for Kinesiophobia in patients with Shoulder Instability (TSK-SI)	Patient reported outcome measure to assess the degree of kinesiophobia	baseline, 26 and 52 weeks postoperative
Secondary	World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF)	Patient reported outcome measure to assess the self reported quality of life	baseline, 26 and 52 weeks postoperative
Secondary	Level of shoulder pain measured by Visual Analogue Scale (VAS)	Level of shoulder pain measured by Visual Analogue Scale (VAS)	baseline, 26 and 52 weeks postoperative
Secondary	Number of patients that return to work (RTW) following the surgery	Number of patients that return to work (RTW) following the surgery	26 and 52 weeks postoperative
Secondary	Number of patients tha return to sport (RTS) following the surgery	Number of patients tha return to sport (RTS) following the surgery	26 and 52 weeks postoperative
Secondary	Patient satisfaction regarding the surgical treatment and rehabilitation, measured by VAS	Patient satisfaction regarding the surgical treatment and rehabilitation, measured by VAS	baseline, 26 weeks and 52 weeks postoperative
Secondary	The number of physiotherapy and orthopedic surgeon visits	The number of physiotherapy and orthopedic surgeon visits	From start to end of treatment
Secondary	Task-based brain activity, measured in voxels	Analysis using functional Magnetic Resonance Imaging (fMRI) to determine functional cerebral changes after treatment	baseline and 26 weeks postoperative