Feasibility of the Sinex Program for Shoulder Instability

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

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).

Study Overview

• Status: Completed
• Conditions: Anterior Shoulder Dislocation
• Intervention / Treatment: Other: Sinex program (neuromuscular training program)

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bergen, Norway, 5020
    • Bergen University College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ontario Shoulder Instability Index (WOSI)	change in shoulder quality of life	Baseline, 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Western Norway University of Applied Sciences

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): August 31, 2018

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 1, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: feasibility studies; shoulder instability; neuromuscular exercise
• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Joint Dislocations; Shoulder Dislocation
• Other Study ID Numbers: 2017/1189/REK vest

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No