A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Shoulder Dislocation
- Sponsor
- University of Southern Denmark
- Enrollment
- 56
- Locations
- 4
- Primary Endpoint
- Change in Western Ontario Shoulder Instability Index (WOSI)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Henrik Eshoj
Msc, PhD. stud
University of Southern Denmark
Eligibility Criteria
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
- •Inadequacy in written and spoken Danish
- •Not willing or able to attend 12 weeks of supervised exercise therapy
Outcomes
Primary Outcomes
Change in Western Ontario Shoulder Instability Index (WOSI)
Time Frame: Primary: 3 months. Other: 12, 24 months
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).
Secondary Outcomes
- Change in Euro Qol 5D Index (EQ-5D)(3,12, 24 months)
- Change in Tampa Scale of Kinesiophobia(3,12, 24 months)
- Change in the four sub-scales (domains) of WOSI(3,12, 24 months)
- Change in Patient Specific Functioning Scale(3 months)
- Global Perceived Effect(3 months)
- Change in Constant-Murley Shoulder Score(3 months)
- Number of changes in positive clinical tests for anterior shoulder instability(3 months)
- Change in shoulder joint position sense(3 months)
- Number of participants with adverse events(3 months)