Feasibility of the Sinex Program for Shoulder Instability
Primary Purpose
Anterior Shoulder Dislocation
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Sinex program (neuromuscular training program)
Sponsored by
About this trial
This is an interventional treatment trial for Anterior Shoulder Dislocation focused on measuring shoulder instability, feasibility studies, neuromuscular exercise
Eligibility Criteria
Inclusion Criteria:
- men and women, between 16 and 45 years of age, minimum one traumatic anterior shoulder dislocation diagnosed with TASI, eligible for stabilizing Bankart surgery
Exclusion Criteria:
- 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
Sites / Locations
- Bergen University College
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Feasibility of the SINEX for treatment of shoulder instability
Arm Description
Feasibility of the SINEX program for treatment and evaluation of of traumatic anterior shoulder instability eligible for surgery
Outcomes
Primary Outcome Measures
Ontario Shoulder Instability Index (WOSI)
change in shoulder quality of life
Secondary Outcome Measures
Tampa Scale of Kinesiophobia (TSK)
Change in fear of movement and re-injury, numbers
Sensorimotor control measured by center of pressure path length (COPL)
Change in shoulder stability, mm
Shoulder joint position sense (SJPS)
Change in shoulder position stability, degrees
Isometric strength measured by Constant Score - Isometric Maximal Voluntary Contraction (CS-iMVC)
Change in muscle strength, kg
Apprehension and relocation tests
Change in anterior glenohumeral instability, positive/negative
Global Perceived Effect questionnaire (GPE)
Impression of change, 1-7
Full Information
NCT ID
NCT04152304
First Posted
October 28, 2019
Last Updated
November 1, 2019
Sponsor
Western Norway University of Applied Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04152304
Brief Title
Feasibility of the Sinex Program for Shoulder Instability
Official Title
Feasibility of the SINEX Program for Patients With Traumatic Anterior Shoulder Instability
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
August 31, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Norway University of Applied Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Shoulder Dislocation
Keywords
shoulder instability, feasibility studies, neuromuscular exercise
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility study. One group before and after design
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Feasibility of the SINEX for treatment of shoulder instability
Arm Type
Experimental
Arm Description
Feasibility of the SINEX program for treatment and evaluation of of traumatic anterior shoulder instability eligible for surgery
Intervention Type
Other
Intervention Name(s)
Sinex program (neuromuscular training program)
Intervention Description
The SINEX program is a three months neuromuscular training program aiming to increase neuromuscular stability of the shoulder
Primary Outcome Measure Information:
Title
Ontario Shoulder Instability Index (WOSI)
Description
change in shoulder quality of life
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Tampa Scale of Kinesiophobia (TSK)
Description
Change in fear of movement and re-injury, numbers
Time Frame
Baseline, 12 weeks
Title
Sensorimotor control measured by center of pressure path length (COPL)
Description
Change in shoulder stability, mm
Time Frame
Baseline, 12 weeks
Title
Shoulder joint position sense (SJPS)
Description
Change in shoulder position stability, degrees
Time Frame
Baseline, 12 weeks
Title
Isometric strength measured by Constant Score - Isometric Maximal Voluntary Contraction (CS-iMVC)
Description
Change in muscle strength, kg
Time Frame
Baseline, 12 weeks
Title
Apprehension and relocation tests
Description
Change in anterior glenohumeral instability, positive/negative
Time Frame
Baseline, 12 weeks
Title
Global Perceived Effect questionnaire (GPE)
Description
Impression of change, 1-7
Time Frame
at 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
men and women, between 16 and 45 years of age, minimum one traumatic anterior shoulder dislocation diagnosed with TASI, eligible for stabilizing Bankart surgery
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gro Anita F Flaten, ph.d.
Organizational Affiliation
Western Norway University of Applied Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Bergen University College
City
Bergen
ZIP/Postal Code
5020
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
33042568
Citation
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.
Results Reference
derived
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Feasibility of the Sinex Program for Shoulder Instability
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