Shoulder DislocationSINEXNCT02371928
A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability
A study testing Neuromuscular exercise program and Standard home exercise program in people with Shoulder Dislocation and Musculoskeletal Diseases, run by University of Southern Denmark at 4 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Shoulder Dislocation, Musculoskeletal Diseases
- What is being tested?
- Neuromuscular exercise program and Standard home exercise program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 4 sitesDenmark
- Study dates
- Feb 2015to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Aalborg University Hospital
Aalborg, Jutland, 9000
Hospital of Southwest Denmark
Esbjerg, Jutland, 6700
Himmerland Hospital
Farsø, Jutland, 9640
Odense University Hospital
Odense, Fyn, 5000
About this study
Official title: A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability: A Randomized Controlled Trial
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
Read the 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.
- Conditions
- Shoulder Dislocation, Musculoskeletal Diseases
- Being tested
- Neuromuscular exercise program, Standard home exercise program
- Keywords
- Shoulder, Instability, Neuromuscular, Physiotherapy, Exercise, Dislocation, Recurrence
- Medical subject headings
- Shoulder Dislocation, Musculoskeletal Diseases, Motor Activity, Joint Dislocations, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuromuscular exercise programOther
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 programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Neuromuscular exercise program | Active comparator | 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. Receives: Other: Neuromuscular exercise program |
| Standard home exercise program | Active comparator | 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. Receives: Other: Standard home exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Western Ontario Shoulder Instability Index (WOSI)
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).
Measured: Primary: 3 months. Other: 12, 24 months
Secondary outcomes (9)
Change in Euro Qol 5D Index (EQ-5D)
Quality of life questionnaire
Measured: 3,12, 24 months
Change in Tampa Scale of Kinesiophobia
Fear of movement and re-injury questionnaire
Measured: 3,12, 24 months
Change in the four sub-scales (domains) of WOSI
Questionnaire
Measured: 3,12, 24 months
Change in Patient Specific Functioning Scale
Questionnaire
Measured: 3 months
Global Perceived Effect
Questionnaire
Measured: 3 months
Change in Constant-Murley Shoulder Score
100-point scoring system with self-reported and objective measurements included.
Measured: 3 months
Number of changes in positive clinical tests for anterior shoulder instability
Provocative clinical tests for anterior shoulder instability will be used to measure the number of positive and negative tests (Apprehension, relocation, surprise test)
Measured: 3 months
Change in shoulder joint position sense
Re-positioning test of the affected shoulder in abduction and flexion with the use of laser pointer measurements.
Measured: 3 months
Number of participants with adverse events
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2015 (estimated)
- Study startFeb 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Region of Southern Denmark, The Danish Rheumatism Association, Aalborg University Hospital
- Responsible party
- Principal investigator, Henrik Eshoj, University of Southern Denmark
- Investigators
- Henrik Eshoj, PhD-student, Principal investigator, Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern DenmarkBirgit Juul-Kristensen, Ass. Prof, Study chair, Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern DenmarkKaren Søgaard, Prof., Study chair, Research Unit for Physical Activity and Health in Working Life, Institute of Sports Science and Clinical Biomechanics, University of Southern DenmarkLars H Frich, MD, Study chair, Shoulder sector, Orthopaedic Department, Odense University Hospital, DenmarkSteen L Jensen, MD, Study chair, Shoulder sector, Orthopedic Department, Aalborg University Hospital, Farsø Hospital, DenmarkSten Rasmussen, MD, Study chair, Department of Clinical Medicine, Aalborg University, Aalborg, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371928
- Sponsor's protocol ID
- S-20140093
- Acronym
- SINEX
- Status last verified
- Mar 2018
- First submitted
- 9 Feb 2015
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15162108Handoll 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.
PubMed 16437506Zech 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.
PubMed 19727032Robinson 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.
PubMed 21915575Eshoj 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.
PubMed 32064291Eshoj 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.
PubMed 28245853
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Neuromuscular Exercise Program for Patients With Anterior Shoulder Instability: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02371928
- Acronym / sponsor ID
- SINEX / S-20140093
- Conditions
- Shoulder Dislocation, Musculoskeletal Diseases
- Keywords
- Shoulder, Instability, Neuromuscular, Physiotherapy, Exercise, Dislocation, Recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Collaborators
- Region of Southern Denmark, The Danish Rheumatism Association, Aalborg University Hospital
- Study start
- Feb 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 26 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neuromuscular exercise program | Active comparator | Other: Neuromuscular exercise programA 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. |
| Standard home exercise program | Active comparator | Other: Standard home exercise programOne 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular exercise programExercises 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. | Other | Neuromuscular exercise program |
| Standard home exercise programStrengthening 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. | Other | Standard home exercise program |
Primary outcome
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).
9 secondary outcomes
Change in Euro Qol 5D Index (EQ-5D)
Time frame: 3,12, 24 months
Change in Tampa Scale of Kinesiophobia
Time frame: 3,12, 24 months
Change in the four sub-scales (domains) of WOSI
Time frame: 3,12, 24 months
Change in Patient Specific Functioning Scale
Time frame: 3 months
Global Perceived Effect
Time frame: 3 months
Change in Constant-Murley Shoulder Score
Time frame: 3 months
Number of changes in positive clinical tests for anterior shoulder instability
Time frame: 3 months
Change in shoulder joint position sense
Time frame: 3 months
Number of participants with adverse events
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Background: PubMed 15162108Gibson 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.
- Background: PubMed 16437506Handoll 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.
- Background: PubMed 19727032Zech 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.
- Background: PubMed 21915575Robinson 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.
- Derived from this study: PubMed 32064291Eshoj 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.
- Derived from this study: PubMed 28245853Eshoj 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henrik Eshoj, PhD-student 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 study chair
Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
Karen Søgaard, Prof. study chair
Research Unit for Physical Activity and Health in Working Life, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular exercise program and Standard home exercise program in people with Shoulder Dislocation and Musculoskeletal Diseases, run by University of Southern Denmark at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Western Ontario Shoulder Instability Index (WOSI) (time frame: Primary: 3 months. Other: 12, 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02371928, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.