A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability (SINEX)

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

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

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.

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.

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.

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.

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.

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).

Provocative clinical tests for anterior shoulder instability will be used to measure the number of positive and negative tests (Apprehension, relocation, surprise test)

Re-positioning test of the affected shoulder in abduction and flexion with the use of laser pointer measurements.

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.

Baseline demographics and other relevant information (age, sex, symptom intensity and duration, number of shoulder dislocations, medical use, prior physical treatment, Time to return to sport or work, )

Pain pressure threshold measured in the affected shoulder using a handheld algometer (Algometer Type II) at four sites (m. pec. major, the deltoid m., m. trapezius superior and m. levator scapula) and one site at opposite m. tibialis anterior.

Using 100 mm visual analogue scale (VAS) with anchor points "no pain" and "worst imaginable pain" in various situations.

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

Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark

Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark

Research Unit for Physical Activity and Health in Working Life, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark

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