A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability

Study Overview
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Brief Summary
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This study is designed to investigate the efficacy and safety of a supervised neuromuscular exercise program versus a standard home exercise program for patients with post-traumatic symptomatic anterior shoulder instability. Participants with at least one week of symptom duration are randomly assigned to either a 12-week structured, supervised Shoulder Instability Neuromuscular EXercise (SINEX) program versus a standard HOMe EXercise (HOMEX) program. The H1-hypothesis is that the SINEX program results in a greater increase in quality of life and physical function than the HOMEX program at the primary endpoint at three months follow-up from baseline

Detailed Description
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A common, and very painful, injury for individuals in their second and third decades is a traumatic dislocated shoulder. This injury accounts for almost 50% of all joint dislocations registered in the emergency departments. Due to post-traumatic laxity and injuries to the surrounding shoulder tissue, one major problem is the risk of developing a chronic recurrent instable shoulder affecting patients both physically and psychologically decreasing their overall quality of life. Biomechanically, proprioceptive changes and decreased sensorimotor control are found in patients with post-traumatic shoulder instability inhibiting the ability to control and stabilize the glenohumeral joint. In other similar musculoskeletal disorders, recent studies clearly shows positive effects of progressive neuromuscular exercise. Finally, no studies have yet investigated the effect of a structured, physical exercise-training regime based on neuromuscular principles targeting the shoulder joint. This trial is performed as a randomized, assessor-blinded, controlled multi-center trial with cooperation from various shoulder outpatient clinics located at different hospitals in The Region of Southern and Northern Denmark.

Official Title
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A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability: A Randomized Controlled Trial

Conditions
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Shoulder Dislocation, Musculoskeletal Diseases

Intervention / Treatment
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* Other: Neuromuscular exercise program
* Other: Standard home exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 18-39 Minimum one radiographic verified anterior shoulder dislocation (total dissociation of the humeral head to the glenoid) Limited ability to maintain a desired level of physical activity (sports/leisure/work) due to pain and/or symptoms in the affected shoulder within the latest week. Exclusion Criteria: Humeral fracture and/or bony bankart (visible on conventional radiographs at the time of presentation) warranted for surgery decided by the orthopedic (no other axial or appendicular musculoskeletal injury) Prior surgery in affected shoulder joint >5 anterior shoulder dislocations (verified by journal or subjective evaluation) Suspected competing diagnosis (e.g. rheumatoid arthritis, cancer, neurological disorders, fibromyalgia, schizophrenia, suicidal threatened, borderline personality disorder or obsessive compulsive disorder Sensory and motor deficits in neck and shoulder Pregnancy Inadequacy in written and spoken Danish Not willing or able to attend 12 weeks of supervised exercise therapy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neuromuscular exercise program<br>A 12-week physiotherapeutic, supervised exercise program with focus on neuromuscular shoulder control besides incorporation of kinetic chain exercises. The exercise program contains the following focal points: Scapula and glenohumeral setting/control, dynamic shoulder stability, muscle co-contractions (weight-bearing upper extremity exercises) and proprioceptive training. | Other: Neuromuscular exercise program<br>* Exercises can be individually progressed from basic to elite level. Low load exercises are performed every day with 2 sets of 20-25 repetitions whereas high load exercises are performed three times per week with 2 sets of 8-12 repetitions. Exercises are progressed using the following components: arm-position, load, speed, open/closed eyes, stable/unstable surfaces. Patients have online access to instructions and video recordings of all exercises and progression levels. Patients are trained to continuously evaluate their own shoulder function and to adjust the exercise levels themselves at home. Supervision will be given two times a week for the first two weeks and then once a week for the remaining period.<br>|
| Active Comparator: Standard home exercise program<br>One physiotherapeutic-supervised instruction in 12 weeks of active exercises for the rotator cuff and scapular muscles. Information about the shoulder injury and how to avoid pain provoking movements besides future implications is given. Also, participants receives one phone call after six weeks of training from a physiotherapist to ensure good compliance and answer any questions that the patient may have. | Other: Standard home exercise program<br>* Strengthening of the rotator cuff muscles are performed with the use of elastic bands (shoulder internal and external rotation besides abduction in scapular plane) whereas mobility/strengthening exercise for the scapular muscles are performed through weight-bearing positions and movements of the upper extremity. All exercises are performed three times a week with 2 sets of 10 repetitions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Western Ontario Shoulder Instability Index (WOSI) | The patient reported outcome, WOSI, consists of four domains covering Physical Symptoms, Sport/Recreation/Work, Lifestyle and Emotions with 21-item questionnaires in all. Each item is scored using a horizontal visual scale ranging from 0 to 100 mm (0-2100, with 0 as the level of no trouble). | Primary: 3 months. Other: 12, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Euro Qol 5D Index (EQ-5D) | Quality of life questionnaire | 3,12, 24 months | 
| Change in Tampa Scale of Kinesiophobia | Fear of movement and re-injury questionnaire | 3,12, 24 months | 
| Change in the four sub-scales (domains) of WOSI | Questionnaire | 3,12, 24 months | 
| Change in Patient Specific Functioning Scale | Questionnaire | 3 months | 
| Global Perceived Effect | Questionnaire | 3 months | 
| Change in Constant-Murley Shoulder Score | 100-point scoring system with self-reported and objective measurements included. | 3 months | 
| Number of changes in positive clinical tests for anterior shoulder instability | Provocative clinical tests for anterior shoulder instability will be used to measure the number of positive and negative tests (Apprehension, relocation, surprise test) | 3 months | 
| Change in shoulder joint position sense | Re-positioning test of the affected shoulder in abduction and flexion with the use of laser pointer measurements. | 3 months | 
| Number of participants with adverse events | Open-probe questioning at 3 months follow-up besides any adverse events during the 12-week exercise program registered by the physiotherapists supervising the patients. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dislocation, Shoulder, Instability, Neuromuscular, Physiotherapy, Exercise, Recurrence