Feasibility of the Sinex Program for Shoulder Instability

NCT04152304 | Completed

• 1 other identifier: 2017/1189/REK vest
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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).

Conditions

Anterior Shoulder Dislocation

Keywords

shoulder instability; feasibility studies; neuromuscular exercise

Outcome Measures

Primary Outcomes (1)

• Ontario Shoulder Instability Index (WOSI)

  change in shoulder quality of life

  Baseline, 12 weeks

Secondary Outcomes (6)

• Tampa Scale of Kinesiophobia (TSK)

  Baseline, 12 weeks

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

  Baseline, 12 weeks

• Shoulder joint position sense (SJPS)

  Baseline, 12 weeks

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

  Baseline, 12 weeks

• Apprehension and relocation tests

  Baseline, 12 weeks

Study Arms (1)

Feasibility of the SINEX for treatment of shoulder instability

EXPERIMENTAL

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

Other: Sinex program (neuromuscular training program)

Interventions

Sinex program (neuromuscular training program) OTHER

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

Feasibility of the SINEX for treatment of shoulder instability

Eligibility Criteria

• Age: 16 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• men and women, between 16 and 45 years of age, minimum one traumatic anterior shoulder dislocation diagnosed with TASI, eligible for stabilizing Bankart surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Western Norway University of Applied Sciences: lead

Study Sites (1)

Bergen University College

Bergen, 5020, Norway

Location

Related Publications (1)

• 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.

  PMID: 33042568 DERIVED

Study Officials

• Gro Anita F Flaten, ph.d.

  Western Norway University of Applied Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Feasibility study. One group before and after design

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: November 5, 2019
• Study Start: September 1, 2017
• Primary Completion: January 31, 2018
• Study Completion: August 31, 2018
• Last Updated: November 5, 2019

Record last verified: 2019-11

Locations

NO (1)