RecruitingACTRN12621001207808

The Effect of A Rehabilitation Program on Patients with Multidirectional Instability of the Glenohumeral Joint: A Functional MRI Study

The Effect of A Rehabilitation Program on Brain Structure and Function in Patients with Multidirectional Instability of the Glenohumeral Joint: A Functional MRI Study

Sponsor

Swinburne University of Technology

Enrollment

60 participants

Start Date

Feb 1, 2022

Study Type

Interventional

Conditions

Multidirectional Instability (MDI) of at the Glenohumeral Joint

Summary

Patients with multidirectional instability (MDI) of the shoulder experience pain, reduced quality of life and exhibit altered neuromuscular patterning of shoulder musculature(Illyés, Kiss, & Kiss, 2009). Previous functional MRI (fMRI) work investigating motor sequence learning in shoulder instability, showed increased activation in the fronto-parietal and motor control network compared to matched controls(Howard et al., 2019). This study will (1) investigate brain structure and function in patients with MDI compared to normal controls, and (2). investigate whether brain structure and function of MDI patients is modified by implementation of a rehabilitation program that is known to exhibit clinical therapeutic benefit. MDI participants and age and gender matched controls will have a baseline fMRI prior to rehabilitation. Structural shoulder MRI will be performed to exclude participants with underlying labral pathology accounting for their instability. Participants with MDI will then complete a 6-month (24 weeks) rehabilitation program aimed at restoring neuromuscular control around the shoulder. The fMRI scan will be repeated 6-months post baseline for MDI participants. The primary outcome will be the fMRI results at baseline and 6-months (24 weeks). Secondary outcomes will include patients reported outcomes, strength and scapula position. Analysis will focus on detecting between-group differences at baseline and within-group differences of MDI participants pre- and post-rehabilitation.

Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 35 Yearss

Plain Language Summary

Simplified for easier understanding

Multidirectional instability (MDI) of the shoulder is a condition where the shoulder joint slips or dislocates in multiple directions without a traumatic injury. It is most common in young women. People with MDI experience pain, reduced function, and altered muscle control around the shoulder. This study investigates whether MDI changes how the brain controls shoulder movement — and whether a 6-month rehabilitation program can 'retrain' those brain patterns. Participants will undergo functional MRI (fMRI) brain scans — which show which areas of the brain activate during movement — before and after completing the 6-month physiotherapy program. The brain scans of MDI participants will be compared with those of healthy matched controls. If rehabilitation normalises brain activation patterns, this could explain why rehab works and guide future treatment design. You may be eligible if you are a female aged 18–35 with symptomatic right shoulder instability in at least two directions (one being downward), with no prior trauma to the shoulder, no structural lesion on MRI, and no previous shoulder surgery. Male participants are excluded to reduce variability in the brain scanning results.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Study Design and Allocation: This study is a non-randomised pre-post intervention study with a control group. The study includes participants with multidirectional instability of the shoulder and age

Study Design and Allocation: This study is a non-randomised pre-post intervention study with a control group. The study includes participants with multidirectional instability of the shoulder and age and gender matched controls. All enrolled participants with multidirectional instability of the shoulder will receive the intervention. Intervention: The intervention delivered will be a shoulder strengthening program called the Watson Multidirectional Instability (MDI) Program. This program has previously been tested for efficacy in a randomised controlled trial (RCT)(Warby, Ford, Hahne, Watson, & Pizzari, 2016). The Watson MDI program is primarily based around maintaining good scapular (shoulder blade) motor control through all stages of the program and progressing exercises into functional ranges. The program has been standardised for use in a previous RCT, however it provides pathways for clinical decision making regarding the most appropriate selection of exercises for a participant. A detailed outline of the protocol has been previously published(Watson, Warby, Balster, Lenssen, & Pizzari, 2016a, 2016b). Procedures and who will deliver the intervention: Participants will attend 18, 30-minute face-to face sessions of physiotherapy over a 24-week period (once a week for 12 weeks and once a fortnight for another 12 weeks) where they will be assessed/reassessed and prescribed/progressed with a specific set of exercises as per the Watson MDI Program. A 24- week intervention period for the treatment of MDI with a rehabilitation program has been shown to result in a large therapeutic benefit (Warby et al., 2016). The physiotherapy treatments will be conducted at the Melbourne Shoulder Group (33 High Street Prahran, 3181) which is a private practice in Melbourne, Australia. Physiotherapists delivering the intervention will have a particular expertise in the treatment of MDI and have a minimum of 4 years post graduate experience. Materials: Participants will be instructed to perform their exercises at home and/or in their gym. Equipment for the relevant program (weights and Therabands) will be supplied. Participants will receive treatment free of charge. The Watson Multidirectional Instability Program: The Watson MDI program aims to establish motor control, endurance, strength then sports specific control of the scapula and humeral head. The parameters of exercise prescription depend on what stage the participant is completing. The program is standardised, however allows for tailoring of individual patients needs and goals. Participants with MDI will perform between 1 and 6 exercises, 15 to 30 minutes a day, 1 to 2 times a day, every day of the week. The stages and exercises for the Watson Multidirectional Instability Program are as follows: Stage 1: a) Regaining scapula motor control (example exercises: scapula upward rotation, elevation drills with 0- 1 kg) b) Regaining humeral head control in 0 degrees of elevation (example exercises: glenohumeral extension, internal and external rotation drills at 0 degrees of elevation with a TheraBand) Stage 2: Establishing additional posterior muscle control and strength (example exercises: scapula upward rotation drills 2kg +, side lie external rotation, bent over rows, TheraBand extension drills from 0 to 45 degrees of elevation) Stage 3: Establishing sagittal plane (flexion) control (example exercises: standing flexion drills with a TheraBand to 90 degrees of elevation) Stage 4: Regaining humeral head control from 45 to 90 degrees of elevation in the sagittal (flexion) and coronal (abduction) plane (example exercises: internal and external rotation at 90 degrees elevation with Therabands. Flexion >90 degrees with Therabands) Stage 5: Deltoid strength (example exercises: supine and standing flexion with weights, bent over row at 30 and 90 degrees of abduction with weights, short lever abduction with weights) Stage 6: Sports Specific Function (Part practise of sports specific drills with Therabands integrating into whole practise) Adherence: To measure compliance with the home exercise program, upon questioning the participant, the trial physiotherapist will give a compliance score at the end of each session, except for session 1 (i.e.: session 2 to 18) and record this in the clinical notes. These scores will be used to calculate a total compliance score at the end of the 18-session (24 week) intervention period. References Ganderton, C., Tirosh, O., Munro, D., Meyer, D., Lenssen, R., Balster, S., . . . Warby, S. (2021). Rehabilitation for atraumatic shoulder instability in circus arts performers: delivered via telehealth. American Journal of Sports Medicine (under review). Warby, S. A., Ford, J. J., Hahne, A. J., Watson, L. A., & Pizzari, T. (2016). Comparison of two exercise rehabilitation programs for multidirectional instability of the glenohumeral joint: A randomised controlled trial. The American Journal of Sports Medicine (Manuscript under review). Watson, L., Warby, S. A., Balster, S., Lenssen, R., & Pizzari, T. (2016a). The treatment of multidirectional instability with an exercise program: Part 1. Shoulder & Elbow, 8(4), 271-278. doi:http://dx.doi.org/10.1177/1758573216652086 Watson, L., Warby, S. A., Balster, S., Lenssen, R., & Pizzari, T. (2016b). The treatment of multidirectional instability with an exercise program: Part 2. Shoulder & Elbow, 0(0), 1-8. doi:http://dx.doi.org/10.1177/1758573216652087

Locations(1)

VIC, Australia

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ACTRN12621001207808