Clinical trial NCT02371928: A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability
Official title: A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Dislocation
Musculoskeletal Diseases
Keywords: Shoulder
Instability
Neuromuscular
Physiotherapy
Exercise
Dislocation
Recurrence
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Region of Southern Denmark
name: The Danish Rheumatism Association
name: Aalborg University Hospital
First posted: 2015-02-26
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Western Ontario Shoulder Instability Index (WOSI)
timeFrame: Primary: 3 months. Other: 12, 24 months
Secondary outcomes:
measure: Change in Euro Qol 5D Index (EQ-5D)
timeFrame: 3,12, 24 months
measure: Change in Tampa Scale of Kinesiophobia
timeFrame: 3,12, 24 months
measure: Change in the four sub-scales (domains) of WOSI
timeFrame: 3,12, 24 months
measure: Change in Patient Specific Functioning Scale
timeFrame: 3 months
measure: Global Perceived Effect
timeFrame: 3 months
measure: Change in Constant-Murley Shoulder Score
timeFrame: 3 months
measure: Number of changes in positive clinical tests for anterior shoulder instability
timeFrame: 3 months
measure: Change in shoulder joint position sense
timeFrame: 3 months
measure: Number of participants with adverse events
timeFrame: 3 months
Other outcomes:
measure: 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, )
timeFrame: Baseline and 3,12, 24 months
measure: Change in mechanical allodynia (exploratory)
timeFrame: 3 months
measure: Change in number of sites with pain (exploratory)
timeFrame: 3 months
measure: Change in pain scores
timeFrame: 3, 12, 24 months
measure: Change in maximum isometric muscle strength
timeFrame: 3 months
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
state: Fyn
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: Jutland
city: Esbjerg
country: Denmark
facility: Hospital of Southwest Denmark
state: Jutland
city: Farsø
country: Denmark
facility: Himmerland Hospital
state: Jutland
Study officials:
affiliation: Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
name: Henrik Eshoj, PhD-student
role: PRINCIPAL_INVESTIGATOR
affiliation: Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
name: Birgit Juul-Kristensen, Ass. Prof
role: STUDY_CHAIR
affiliation: Research Unit for Physical Activity and Health in Working Life, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
name: Karen Søgaard, Prof.
role: STUDY_CHAIR
affiliation: Shoulder sector, Orthopaedic Department, Odense University Hospital, Denmark
name: Lars H Frich, MD
role: STUDY_CHAIR
affiliation: Shoulder sector, Orthopedic Department, Aalborg University Hospital, Farsø Hospital, Denmark
name: Steen L Jensen, MD
role: STUDY_CHAIR
affiliation: Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
name: Sten Rasmussen, MD
role: STUDY_CHAIR
References:
citation: Gibson K, Growse A, Korda L, Wray E, MacDermid JC. The effectiveness of rehabilitation for nonoperative management of shoulder instability: a systematic review. J Hand Ther. 2004 Apr-Jun;17(2):229-42. doi: 10.1197/j.jht.2004.02.010.
citation: Handoll HH, Hanchard NC, Goodchild L, Feary J. Conservative management following closed reduction of traumatic anterior dislocation of the shoulder. Cochrane Database Syst Rev. 2006 Jan 25;(1):CD004962. doi: 10.1002/14651858.CD004962.pub2.
citation: Zech A, Hubscher M, Vogt L, Banzer W, Hansel F, Pfeifer K. Neuromuscular training for rehabilitation of sports injuries: a systematic review. Med Sci Sports Exerc. 2009 Oct;41(10):1831-41. doi: 10.1249/MSS.0b013e3181a3cf0d.
citation: Robinson CM, Seah M, Akhtar MA. The epidemiology, risk of recurrence, and functional outcome after an acute traumatic posterior dislocation of the shoulder. J Bone Joint Surg Am. 2011 Sep 7;93(17):1605-13. doi: 10.2106/JBJS.J.00973.
citation: Eshoj HR, Rasmussen S, Frich LH, Hvass I, Christensen R, Boyle E, Jensen SL, Sondergaard J, Sogaard K, Juul-Kristensen B. Neuromuscular Exercises Improve Shoulder Function More Than Standard Care Exercises in Patients With a Traumatic Anterior Shoulder Dislocation: A Randomized Controlled Trial. Orthop J Sports Med. 2020 Jan 30;8(1):2325967119896102. doi: 10.1177/2325967119896102. eCollection 2020 Jan.
citation: Eshoj H, Rasmussen S, Frich LH, Hvass I, Christensen R, Jensen SL, Sondergaard J, Sogaard K, Juul-Kristensen B. A neuromuscular exercise programme versus standard care for patients with traumatic anterior shoulder instability: study protocol for a randomised controlled trial (the SINEX study). Trials. 2017 Feb 28;18(1):90. doi: 10.1186/s13063-017-1830-x.