A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability
- Conditions
- Shoulder DislocationMusculoskeletal Diseases
- Interventions
- Other: Standard home exercise programOther: Neuromuscular exercise program
- Registration Number
- NCT02371928
- Lead Sponsor
- University of Southern Denmark
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard home exercise program Standard home exercise program 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. Neuromuscular exercise program Neuromuscular exercise program 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.
- Primary Outcome Measures
Name Time Method Change in Western Ontario Shoulder Instability Index (WOSI) 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 Outcome Measures
Name Time Method Change in Euro Qol 5D Index (EQ-5D) 3,12, 24 months Quality of life questionnaire
Change in Tampa Scale of Kinesiophobia 3,12, 24 months Fear of movement and re-injury questionnaire
Change in the four sub-scales (domains) of WOSI 3,12, 24 months Questionnaire
Change in Patient Specific Functioning Scale 3 months Questionnaire
Global Perceived Effect 3 months Questionnaire
Change in Constant-Murley Shoulder Score 3 months 100-point scoring system with self-reported and objective measurements included.
Number of changes in positive clinical tests for anterior shoulder instability 3 months Provocative clinical tests for anterior shoulder instability will be used to measure the number of positive and negative tests (Apprehension, relocation, surprise test)
Change in shoulder joint position sense 3 months Re-positioning test of the affected shoulder in abduction and flexion with the use of laser pointer measurements.
Number of participants with adverse events 3 months 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.
Trial Locations
- Locations (4)
Odense University Hospital
🇩🇰Odense, Fyn, Denmark
Aalborg University Hospital
🇩🇰Aalborg, Jutland, Denmark
Hospital of Southwest Denmark
🇩🇰Esbjerg, Jutland, Denmark
Himmerland Hospital
🇩🇰Farsø, Jutland, Denmark