Anterior Shoulder DislocationNCT04152304
Feasibility of the Sinex Program for Shoulder Instability
A study testing Sinex program (neuromuscular training program) in people with Anterior Shoulder Dislocation, run by Western Norway University of Applied Sciences at 1 site in Norway.
Trial summary
An optimal treatment for traumatic anterior shoulder instability (TASI) remains to be identified. A shoulder instability neuromuscular exercise (SINEX) program has been designed for patients with TASI, but has not yet been tested in patients eligible for surgery. Read more about this study
- Who is it for?
- Ages 16 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Shoulder Dislocation
- What is being tested?
- Sinex program (neuromuscular training program)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2017to 31 Aug 2018
- 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 16 to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- men and women, between 16 and 45 years of age, minimum one traumatic anterior shoulder dislocation diagnosed with TASI, eligible for stabilizing Bankart surgery
Who cannot join
- complex shoulder injuries not suitable for a Bankart procedure as determined by an orthopedic surgeon, insufficient Norwegian language skills, and/or not being able to participate in a supervised exercise program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of the SINEX Program for Patients With Traumatic Anterior Shoulder Instability
An optimal treatment for traumatic anterior shoulder instability (TASI) remains to be identified. A shoulder instability neuromuscular exercise (SINEX) program has been designed for patients with TASI, but has not yet been tested in patients eligible for surgery. The purpose of this study was to investigate and evaluate the feasibility and safety of the SINEX program for patients diagnosed with TASI and eligible for surgery.
A feasibility study with an experimental, longitudinal design using both quantitative and qualitative research methods. Participants undergo the SINEX program, a twelve week exercise program including physiotherapist supervised sessions. Feasibility data on recruitment, retention, compliance, acceptability and safety was collected through observation and individual semi-structured interviews. Clinical tests and self-report questionnaires were completed at baseline and 12 weeks follow-up. Clinical assessments included apprehension and relocation tests, shoulder joint position sense (SJPS), shoulder sensorimotor control measured by center of pressure path length (COPL) on a force platform, isometric strength measured by Constant Score - Isometric Maximal Voluntary Contraction (CS-iMVC), self-report questionnaires included Western Ontario Shoulder Instability Index (WOSI), Tampa Scale of Kinesiophobia (TSK) and Global Perceived Effect questionnaire (GPE).
- Conditions
- Anterior Shoulder Dislocation
- Being tested
- Sinex program (neuromuscular training program)
- Keywords
- shoulder instability, feasibility studies, neuromuscular exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sinex program (neuromuscular training program)Other
The SINEX program is a three months neuromuscular training program aiming to increase neuromuscular stability of the shoulder
| Study group | Role | What they receive |
|---|---|---|
| Feasibility of the SINEX for treatment of shoulder instability | Experimental | Feasibility of the SINEX program for treatment and evaluation of of traumatic anterior shoulder instability eligible for surgery Receives: Other: Sinex program (neuromuscular training program) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ontario Shoulder Instability Index (WOSI)
change in shoulder quality of life
Measured: Baseline, 12 weeks
Secondary outcomes (6)
Tampa Scale of Kinesiophobia (TSK)
Change in fear of movement and re-injury, numbers
Measured: Baseline, 12 weeks
Sensorimotor control measured by center of pressure path length (COPL)
Change in shoulder stability, mm
Measured: Baseline, 12 weeks
Shoulder joint position sense (SJPS)
Change in shoulder position stability, degrees
Measured: Baseline, 12 weeks
Isometric strength measured by Constant Score - Isometric Maximal Voluntary Contraction (CS-iMVC)
Change in muscle strength, kg
Measured: Baseline, 12 weeks
Apprehension and relocation tests
Change in anterior glenohumeral instability, positive/negative
Measured: Baseline, 12 weeks
Global Perceived Effect questionnaire (GPE)
Impression of change, 1-7
Measured: at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start1 Sep 2017
- Primary completion31 Jan 2018
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anterior 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
- Not applicable
- Intervention model
- Single group
- Model description
- Feasibility study. One group before and after design
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Norway University of Applied Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liv Heide Magnussen, Western Norway University of Applied Sciences
- Investigators
- Gro Anita F Flaten, ph.d., Study director, Western Norway University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152304
- Sponsor's protocol ID
- 2017/1189/REK vest
- Status last verified
- Nov 2019
- First submitted
- 28 Oct 2019
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hagesaeter AN, Lovold T, Juul-Kristensen B, Blomquist J, Hole R, Eshoj H, Magnussen LH. Feasibility of the SINEX program for patients with traumatic anterior shoulder instability. Pilot Feasibility Stud. 2020 Oct 6;6:148. doi: 10.1186/s40814-020-00679-x. eCollection 2020.
PubMed 33042568
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the SINEX Program for Patients With Traumatic Anterior Shoulder Instability
- ClinicalTrials.gov ID
- NCT04152304
- Acronym / sponsor ID
- 2017/1189/REK vest
- Conditions
- Anterior Shoulder Dislocation
- Keywords
- shoulder instability, feasibility studies, neuromuscular exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Western Norway University of Applied SciencesUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 5 Nov 2019 (actual)
- 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.
An optimal treatment for traumatic anterior shoulder instability (TASI) remains to be identified. A shoulder instability neuromuscular exercise (SINEX) program has been designed for patients with TASI, but has not yet been tested in patients eligible for surgery. The purpose of this study was to investigate and evaluate the feasibility and safety of the SINEX program for patients diagnosed with TASI and eligible for surgery.
A feasibility study with an experimental, longitudinal design using both quantitative and qualitative research methods. Participants undergo the SINEX program, a twelve week exercise program including physiotherapist supervised sessions. Feasibility data on recruitment, retention, compliance, acceptability and safety was collected through observation and individual semi-structured interviews. Clinical tests and self-report questionnaires were completed at baseline and 12 weeks follow-up. Clinical assessments included apprehension and relocation tests, shoulder joint position sense (SJPS), shoulder sensorimotor control measured by center of pressure path length (COPL) on a force platform, isometric strength measured by Constant Score - Isometric Maximal Voluntary Contraction (CS-iMVC), self-report questionnaires included Western Ontario Shoulder Instability Index (WOSI), Tampa Scale of Kinesiophobia (TSK) and Global Perceived Effect questionnaire (GPE).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Feasibility study. One group before and after design
| Arm | Type | Receives |
|---|---|---|
| Feasibility of the SINEX for treatment of shoulder instability | Experimental | Other: Sinex program (neuromuscular training program)Feasibility of the SINEX program for treatment and evaluation of of traumatic anterior shoulder instability eligible for surgery |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- men and women, between 16 and 45 years of age, minimum one traumatic anterior shoulder dislocation diagnosed with TASI, eligible for stabilizing Bankart surgery
Key exclusion criteria (1 listed)
- complex shoulder injuries not suitable for a Bankart procedure as determined by an orthopedic surgeon, insufficient Norwegian language skills, and/or not being able to participate in a supervised exercise program
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 |
|---|---|---|
| Sinex program (neuromuscular training program)The SINEX program is a three months neuromuscular training program aiming to increase neuromuscular stability of the shoulder | Other | Feasibility of the SINEX for treatment of shoulder instability |
Primary outcome
Ontario Shoulder Instability Index (WOSI)
Time frame: Baseline, 12 weeks
change in shoulder quality of life
6 secondary outcomes
Tampa Scale of Kinesiophobia (TSK)
Time frame: Baseline, 12 weeks
Sensorimotor control measured by center of pressure path length (COPL)
Time frame: Baseline, 12 weeks
Shoulder joint position sense (SJPS)
Time frame: Baseline, 12 weeks
Isometric strength measured by Constant Score - Isometric Maximal Voluntary Contraction (CS-iMVC)
Time frame: Baseline, 12 weeks
Apprehension and relocation tests
Time frame: Baseline, 12 weeks
Global Perceived Effect questionnaire (GPE)
Time frame: at 12 weeks
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 5 Nov 2019.
- Derived from this study: PubMed 33042568Hagesaeter AN, Lovold T, Juul-Kristensen B, Blomquist J, Hole R, Eshoj H, Magnussen LH. Feasibility of the SINEX program for patients with traumatic anterior shoulder instability. Pilot Feasibility Stud. 2020 Oct 6;6:148. doi: 10.1186/s40814-020-00679-x. eCollection 2020.
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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.
Gro Anita F Flaten, ph.d. study director
Western Norway University of Applied Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sinex program (neuromuscular training program) in people with Anterior Shoulder Dislocation, run by Western Norway University of Applied Sciences at 1 site in Norway.
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 1 inclusion and 1 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 5 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. 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?
Ontario Shoulder Instability Index (WOSI) (time frame: Baseline, 12 weeks). 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 NCT04152304, which also lists 1 linked publication.
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 5 Nov 2019.