Shoulder InstabilityMATASINCT06157229
Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair
A study testing MAT and CABRR in people with Shoulder Instability and Shoulder Dislocation or Subluxation, run by Spaarne Gasthuis.
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… Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Shoulder Instability, Shoulder Dislocation or Subluxation, Fear of Movement
- What is being tested?
- MAT and CABRR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair, a Randomized Controlled 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.
Read the 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.
- Conditions
- Shoulder Instability, Shoulder Dislocation or Subluxation, Fear of Movement, Kinesiophobia
- Being tested
- MAT, CABRR
- Medical subject headings
- Shoulder Dislocation, Joint Dislocations, Kinesiophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MATOther
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
CABRROther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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]. Receives: Other: CABRR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Instability Return to Sport Index (SIRSI)
Patient reported outcome measure to assess psychological readiness to return to sport in patients with shoulder instability
Measured: 26 weeks postoperative
Secondary outcomes (11)
Oxford Shoulder Instability Score (OSIS)
Patient reported shoulder function between MAT and CABRR
Measured: 26 and 52 weeks postoperative
Shoulder function, measured by Subjective Shoulder value (SSV)
Shoulder function, measured by Subjective Shoulder value (SSV)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: baseline, 26 weeks and 52 weeks postoperative
The number of physiotherapy and orthopedic surgeon visits
The number of physiotherapy and orthopedic surgeon visits
Measured: 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
Measured: baseline and 26 weeks postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Jan 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Shoulder InstabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Spaarne Gasthuis
- Sponsor type
- University, hospital or other
- Collaborators
- OLVG, Ziekenhuis Amstelland, Gelre Hospitals, Medisch Spectrum Twente, Flevoziekenhuis
- Responsible party
- Sponsor
- Investigators
- Arthur van Noort, MD PhD, Principal investigator, Orthopedic Surgeon and Head of Residency Program, Spaarne Gasthuis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157229
- Sponsor's protocol ID
- reudctionapprehension
- Acronym
- MATASI
- Status last verified
- Nov 2023
- First submitted
- 20 Jun 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 20195022van 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.
PubMed 37811392
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifactorial Approach Training for Anterior Shoulder Instability in Patients Undergoing Arthroscopic Bankart Repair, a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06157229
- Acronym / sponsor ID
- MATASI / reudctionapprehension
- Conditions
- Shoulder Instability, Shoulder Dislocation or Subluxation, Fear of Movement, Kinesiophobia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Spaarne GasthuisUniversity, hospital or other
- Collaborators
- OLVG, Ziekenhuis Amstelland, Gelre Hospitals, Medisch Spectrum Twente, Flevoziekenhuis
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 5 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multifactorial Approach Training (MAT) | Experimental | Other: MATMAT 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. |
| Conventional Arthroscopic Bankart Repair Rehabilitation (CABRR) | Active comparator | Other: CABRRThe original guidelines which most physiotherapists use throughout the rehabilitation of their patients following ABR is the ASSET guideline [2]. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MATThe 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 | Other | Multifactorial Approach Training (MAT) |
| CABRRThe 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. | Other | Conventional Arthroscopic Bankart Repair Rehabilitation (CABRR) |
Primary outcome
Shoulder Instability Return to Sport Index (SIRSI)
Time frame: 26 weeks postoperative
Patient reported outcome measure to assess psychological readiness to return to sport in patients with shoulder instability
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Background: PubMed 20195022Gaunt 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.
- Background: PubMed 37811392van 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arthur van Noort, MD PhD principal investigator
Orthopedic Surgeon and Head of Residency Program, Spaarne Gasthuis
Questions about this trial
What is this clinical trial studying?
A study testing MAT and CABRR in people with Shoulder Instability and Shoulder Dislocation or Subluxation, run by Spaarne Gasthuis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Madu N Soares, BSc. (+31648164073, msoaresfilho@spaarnegasthuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Instability Return to Sport Index (SIRSI) (time frame: 26 weeks postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06157229, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.