Feasibility of the Sinex Program for Shoulder Instability

Anterior Shoulder Dislocation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04152304
• Other study ID #: 2017/1189/REK vest
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: November 2019
• Source: Western Norway University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: August 31, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anterior Shoulder Dislocation
• Shoulder Dislocation

Intervention

Other:
• Sinex program (neuromuscular training program)
The SINEX program is a three months neuromuscular training program aiming to increase neuromuscular stability of the shoulder

Locations

Country	Name	City	State
Norway	Bergen University College	Bergen

Sponsors (1)

Lead Sponsor	Collaborator
Western Norway University of Applied Sciences

Country where clinical trial is conducted

Norway, 

Outcome

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