Feasibility of the Sinex Program for Shoulder Instability

Study Overview
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Brief Summary
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An optimal treatment for traumatic anterior shoulder instability (TASI) remains to be identified. A shoulder instability neuromuscular exercise (SINEX) program has been designed for patients with TASI, but has not yet been tested in patients eligible for surgery. The purpose of this study was to investigate and evaluate the feasibility and safety of the SINEX program for patients diagnosed with TASI and eligible for surgery. A feasibility study with an experimental, longitudinal design using both quantitative and qualitative research methods. Participants undergo the SINEX program, a twelve week exercise program including physiotherapist supervised sessions. Feasibility data on recruitment, retention, compliance, acceptability and safety was collected through observation and individual semi-structured interviews. Clinical tests and self-report questionnaires were completed at baseline and 12 weeks follow-up. Clinical assessments included apprehension and relocation tests, shoulder joint position sense (SJPS), shoulder sensorimotor control measured by center of pressure path length (COPL) on a force platform, isometric strength measured by Constant Score - Isometric Maximal Voluntary Contraction (CS-iMVC), self-report questionnaires included Western Ontario Shoulder Instability Index (WOSI), Tampa Scale of Kinesiophobia (TSK) and Global Perceived Effect questionnaire (GPE).

Official Title
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Feasibility of the SINEX Program for Patients With Traumatic Anterior Shoulder Instability

Conditions
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Anterior Shoulder Dislocation

Intervention / Treatment
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* Other: Sinex program (neuromuscular training program)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: men and women, between 16 and 45 years of age, minimum one traumatic anterior shoulder dislocation diagnosed with TASI, eligible for stabilizing Bankart surgery Exclusion Criteria: complex shoulder injuries not suitable for a Bankart procedure as determined by an orthopedic surgeon, insufficient Norwegian language skills, and/or not being able to participate in a supervised exercise program

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility study. One group before and after design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feasibility of the SINEX for treatment of shoulder instability<br>Feasibility of the SINEX program for treatment and evaluation of of traumatic anterior shoulder instability eligible for surgery | Other: Sinex program (neuromuscular training program)<br>* The SINEX program is a three months neuromuscular training program aiming to increase neuromuscular stability of the shoulder<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ontario Shoulder Instability Index (WOSI) | change in shoulder quality of life | Baseline, 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tampa Scale of Kinesiophobia (TSK) | Change in fear of movement and re-injury, numbers | Baseline, 12 weeks | 
| Sensorimotor control measured by center of pressure path length (COPL) | Change in shoulder stability, mm | Baseline, 12 weeks | 
| Shoulder joint position sense (SJPS) | Change in shoulder position stability, degrees | Baseline, 12 weeks | 
| Isometric strength measured by Constant Score - Isometric Maximal Voluntary Contraction (CS-iMVC) | Change in muscle strength, kg | Baseline, 12 weeks | 
| Apprehension and relocation tests | Change in anterior glenohumeral instability, positive/negative | Baseline, 12 weeks | 
| Global Perceived Effect questionnaire (GPE) | Impression of change, 1-7 | at 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder instability, feasibility studies, neuromuscular exercise