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OpenTrials
Completed

NCT Number: NCT04152304

Feasibility of the Sinex Program for 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).

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Key information

Age range

16 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bergen University College

Bergen, 5020, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sinex program (neuromuscular training program)

Other

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

Primary outcomes

  1. Ontario Shoulder Instability Index (WOSI)

    Time frame: Baseline, 12 weeks

    change in shoulder quality of life

Secondary outcomes

  1. Tampa Scale of Kinesiophobia (TSK)

    Time frame: Baseline, 12 weeks

    Change in fear of movement and re-injury, numbers

  2. Sensorimotor control measured by center of pressure path length (COPL)

    Time frame: Baseline, 12 weeks

    Change in shoulder stability, mm

  3. Shoulder joint position sense (SJPS)

    Time frame: Baseline, 12 weeks

    Change in shoulder position stability, degrees

  4. Isometric strength measured by Constant Score - Isometric Maximal Voluntary Contraction (CS-iMVC)

    Time frame: Baseline, 12 weeks

    Change in muscle strength, kg

  5. Apprehension and relocation tests

    Time frame: Baseline, 12 weeks

    Change in anterior glenohumeral instability, positive/negative

  6. Global Perceived Effect questionnaire (GPE)

    Time frame: at 12 weeks

    Impression of change, 1-7

Sponsors and collaborators

Lead sponsor

Western Norway University of Applied Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 5, 2019
Registry last updated
Nov 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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