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

NCT06157229 | Not Yet Recruiting

• 1 other identifier: reudctionapprehension
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Shoulder Instability; Shoulder Dislocation or Subluxation; Fear of Movement; Kinesiophobia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Oxford Shoulder Instability Score (OSIS)

  26 and 52 weeks postoperative

• Shoulder function, measured by Subjective Shoulder value (SSV)

  baseline, 26 and 52 weeks postoperative

• Fear of recurrent dislocation, measured by Numeric Rating Scale (NRS)

  baseline, 26 and 52 weeks postoperative

• Tampa Scale for Kinesiophobia in patients with Shoulder Instability (TSK-SI)

  baseline, 26 and 52 weeks postoperative

• World Health Organization Qualitiy of Life Questionnaire - BREF (WHOQoL-BREF)

  baseline, 26 and 52 weeks postoperative

Study Arms (2)

Multifactorial Approach Training (MAT)

EXPERIMENTAL

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

Conventional Arthroscopic Bankart Repair Rehabilitation (CABRR)

ACTIVE COMPARATOR

The original guidelines which most physiotherapists use throughout the rehabilitation of their patients following ABR is the ASSET guideline \[2\].

Other: CABRR

Interventions

MAT OTHER

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

Multifactorial Approach Training (MAT)

CABRR OTHER

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.

Conventional Arthroscopic Bankart Repair Rehabilitation (CABRR)

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Spaarne Gasthuis: lead
• OLVG: collaborator
• Ziekenhuis Amstelland: collaborator
• Gelre Hospitals: collaborator
• Medisch Spectrum Twente: collaborator
• Flevoziekenhuis: collaborator

Related 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.

  PMID: 20195022 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Shoulder Dislocation; Joint Dislocations; Kinesiophobia

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Wounds and Injuries; Shoulder Injuries; Phobic Disorders; Anxiety Disorders; Mental Disorders

Study Officials

• Arthur van Noort, MD PhD

  Orthopedic Surgeon and Head of Residency Program, Spaarne Gasthuis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Madu N Soares, BSc.

CONTACT

+31648164073; msoaresfilho@spaarnegasthuis.nl

Theodore P van Iersel, MD

CONTACT

+31614564784; vanierselted@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: December 5, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: December 5, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share