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

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

Inclusion Criteria8

  • Symptomatic shoulder instability in at least 2 directions (one direction being inferior).
  • Aged 18 to 35 years
  • Female. MDI is more prevalent in the female population and excluding males will limit any bias due to potential gender effects.
  • Right shoulder affected. Participants with a right affected shoulder will be included in this study to limit the potential biases that may result from differences in measuring the left and right sides of the brain from participants with left and right shoulder problems. In this study, fMRI effects of the LEFT brain will be measured from participants with a right sided shoulder problem.
  • No history of trauma to the affected shoulder
  • No structural lesion on a clinical Magnetic Resonance Imaging scan.
  • Ability to understand the English language and willingness to participant in a rehabilitation program.
  • Aged and gender matched controls with no history of shoulder problems for each included MDI participant

Exclusion Criteria9

  • Male
  • Shoulder instability due to trauma, central nervous system lesions, peripheral lesions and any other neurological disorders
  • Patients with significant neck (cervical spine) pathology
  • Participants will any history of shoulder surgery
  • Inability to understand or speak English
  • Existence of MRI contraindications
  • Participants who are planning surgery between baseline and follow-up FMRI imaging
  • Participants who are or are planning to become pregnant
  • Patients with contraindications to standard MRI or fMRI

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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