A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability
NCT ID: NCT02371928
Last Updated: 2018-03-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
56 participants
INTERVENTIONAL
2015-02-28
2017-06-30
Brief Summary
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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
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Neuromuscular exercise program
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.
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.
Standard home exercise program
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.
Interventions
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Neuromuscular exercise program
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.
Standard home exercise program
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
39 Years
ALL
No
Sponsors
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Region of Southern Denmark
OTHER
The Danish Rheumatism Association
OTHER
Aalborg University Hospital
OTHER
University of Southern Denmark
OTHER
Responsible Party
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Henrik Eshoj
Msc, PhD. stud
Principal Investigators
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Henrik Eshoj, PhD-student
Role: PRINCIPAL_INVESTIGATOR
Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
Birgit Juul-Kristensen, Ass. Prof
Role: STUDY_CHAIR
Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
Karen Søgaard, Prof.
Role: STUDY_CHAIR
Research Unit for Physical Activity and Health in Working Life, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
Lars H Frich, MD
Role: STUDY_CHAIR
Shoulder sector, Orthopaedic Department, Odense University Hospital, Denmark
Steen L Jensen, MD
Role: STUDY_CHAIR
Shoulder sector, Orthopedic Department, Aalborg University Hospital, Farsø Hospital, Denmark
Sten Rasmussen, MD
Role: STUDY_CHAIR
Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
Locations
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Odense University Hospital
Odense, Fyn, Denmark
Aalborg University Hospital
Aalborg, Jutland, Denmark
Hospital of Southwest Denmark
Esbjerg, Jutland, Denmark
Himmerland Hospital
Farsø, Jutland, Denmark
Countries
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References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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S-20140093
Identifier Type: -
Identifier Source: org_study_id
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