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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-67
SponsorSpaarne Gasthuis

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • MAT

    Other intervention

    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

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Multifactorial Approach Training (MAT)Experimental treatment 1 intervention
Group B: Conventional Arthroscopic Bankart Repair Rehabilitation (CABRR)Active comparator 1 intervention

Trial outcomes

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

Time frame
26 weeks postoperative

Secondary outcomes

1

Oxford Shoulder Instability Score (OSIS)

Patient reported shoulder function between MAT and CABRR

Time frame
26 and 52 weeks postoperative
2

Shoulder function, measured by Subjective Shoulder value (SSV)

Shoulder function, measured by Subjective Shoulder value (SSV)

Time frame
baseline, 26 and 52 weeks postoperative
3

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
4

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Spaarne Gasthuis

Lead sponsor

OLVG

Collaborator

Ziekenhuis Amstelland

Collaborator

Gelre Hospitals

Collaborator

Medisch Spectrum Twente

Collaborator

Flevoziekenhuis

Collaborator

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