Feasibility of the Sinex Program for Shoulder Instability

Sponsor

Western Norway University of Applied Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT04152304

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Anterior Shoulder Dislocation	Other: Sinex program (neuromuscular training program)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Feasibility study. One group before and after designFeasibility study. One group before and after design

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2017

Actual Primary Completion Date :

Jan 31, 2018

Actual Study Completion Date :

Aug 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Feasibility of the SINEX for treatment of shoulder instability Feasibility of the SINEX program for treatment and evaluation of of traumatic anterior shoulder instability eligible for surgery	Other: Sinex program (neuromuscular training program) The SINEX program is a three months neuromuscular training program aiming to increase neuromuscular stability of the shoulder

Arm

Intervention/Treatment

Experimental: Feasibility of the SINEX for treatment of shoulder instability

Feasibility of the SINEX program for treatment and evaluation of of traumatic anterior shoulder instability eligible for surgery

Other: Sinex program (neuromuscular training program)

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

Outcome Measures

Primary Outcome Measures

Ontario Shoulder Instability Index (WOSI) [Baseline, 12 weeks]
change in shoulder quality of life

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bergen University College	Bergen		Norway	5020

Sponsors and Collaborators

Western Norway University of Applied Sciences

Investigators

Study Director: Gro Anita F Flaten, ph.d., Western Norway University of Applied Sciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Liv Heide Magnussen, Professor, Western Norway University of Applied Sciences

ClinicalTrials.gov Identifier:

NCT04152304

Other Study ID Numbers:

2017/1189/REK vest

First Posted:

Nov 5, 2019

Last Update Posted:

Nov 5, 2019

Last Verified:

Nov 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Liv Heide Magnussen, Professor, Western Norway University of Applied Sciences

shoulder instability

feasibility studies

neuromuscular exercise

Additional relevant MeSH terms:

Shoulder Dislocation

Study Results

No Results Posted as of Nov 5, 2019