Feasibility of the Sinex Program for Shoulder Instability

Not Applicable

Completed

• Conditions: Anterior Shoulder Dislocation
• Interventions: Other: Sinex program (neuromuscular training program)

• Registration Number: NCT04152304
• Lead Sponsor: Western Norway University of Applied Sciences

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-01
• Primary Completion: 2018-01-31
• Study Completion: 2018-08-31
• Study First Submitted: 2019-10-28
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-01
• Last Update Submitted: 2019-11-01
• Study First Posted: 2019-11-05
• Last Update Posted: 2019-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Feasibility of the SINEX for treatment of shoulder instability	Sinex program (neuromuscular training program)	Feasibility of the SINEX program for treatment and evaluation of of traumatic anterior shoulder instability eligible for surgery

Primary Outcome Measures

Name	Time	Method
Ontario Shoulder Instability Index (WOSI)	Baseline, 12 weeks	change in shoulder quality of life

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bergen University College; 🇳🇴 Bergen, Norway