Feasibility of the Sinex Program for Shoulder Instability

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2018-08-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Anterior Shoulder Dislocation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Feasibility study. One group before and after design

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Sinex program (neuromuscular training program)

Intervention Type OTHER

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

Interventions

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Sinex program (neuromuscular training program)

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

16 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes