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

University of Southern Denmark (SDU)

Status: Completed

Conditions: Shoulder Dislocation; Musculoskeletal Diseases

Treatments: Other: Neuromuscular exercise program; Other: Standard home exercise program

Study type: Interventional

Funder types: Other

Identifiers

NCT02371928

S-20140093

Details and patient eligibility

About

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

Full description

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age between 18-39
2. Minimum one radiographic verified anterior shoulder dislocation (total dissociation of the humeral head to the glenoid)
3. 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

1. 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)
2. Prior surgery in affected shoulder joint
3. >5 anterior shoulder dislocations (verified by journal or subjective evaluation)
4. Suspected competing diagnosis (e.g. rheumatoid arthritis, cancer, neurological disorders, fibromyalgia, schizophrenia, suicidal threatened, borderline personality disorder or obsessive compulsive disorder
5. Sensory and motor deficits in neck and shoulder
6. Pregnancy
7. Inadequacy in written and spoken Danish
8. Not willing or able to attend 12 weeks of supervised exercise therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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56 participants in 2 patient groups

Neuromuscular exercise program

Active Comparator group

Description:

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.

Treatment:

Other: Neuromuscular exercise program

Standard home exercise program

Active Comparator group

Description:

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.

Treatment:

Other: Standard home exercise program