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Feasibility of the Sinex Program for Shoulder Instability

Feasibility of the SINEX Program for Patients With Traumatic Anterior Shoulder Instability

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04152304
Enrollment
7
Registered
2019-11-05
Start date
2017-09-01
Completion date
2018-08-31
Last updated
2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anterior Shoulder Dislocation

Keywords

shoulder instability, feasibility studies, neuromuscular exercise

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).

Interventions

OTHERSinex program (neuromuscular training program)

The SINEX program is a three months neuromuscular training program aiming to increase neuromuscular stability of the shoulder

Sponsors

Western Norway University of Applied Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Feasibility study. One group before and after design

Eligibility

Sex/Gender
ALL
Age
16 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Ontario Shoulder Instability Index (WOSI)Baseline, 12 weekschange in shoulder quality of life

Secondary

MeasureTime frameDescription
Sensorimotor control measured by center of pressure path length (COPL)Baseline, 12 weeksChange in shoulder stability, mm
Shoulder joint position sense (SJPS)Baseline, 12 weeksChange in shoulder position stability, degrees
Tampa Scale of Kinesiophobia (TSK)Baseline, 12 weeksChange in fear of movement and re-injury, numbers
Apprehension and relocation testsBaseline, 12 weeksChange in anterior glenohumeral instability, positive/negative
Global Perceived Effect questionnaire (GPE)at 12 weeksImpression of change, 1-7
Isometric strength measured by Constant Score - Isometric Maximal Voluntary Contraction (CS-iMVC)Baseline, 12 weeksChange in muscle strength, kg

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026