Clinical trial NCT04152304: Feasibility of the Sinex Program for Shoulder Instability
Official title: Feasibility of the SINEX Program for Patients With Traumatic Anterior Shoulder Instability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anterior Shoulder Dislocation
Keywords: shoulder instability
feasibility studies
neuromuscular exercise
Lead sponsor: Western Norway University of Applied Sciences
Sponsor class: OTHER
First posted: 2019-11-05
Enrollment: 7
Sex: ALL
Minimum age (years): 16
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility study. One group before and after design
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Ontario Shoulder Instability Index (WOSI)
timeFrame: Baseline, 12 weeks
Secondary outcomes:
measure: Tampa Scale of Kinesiophobia (TSK)
timeFrame: Baseline, 12 weeks
measure: Sensorimotor control measured by center of pressure path length (COPL)
timeFrame: Baseline, 12 weeks
measure: Shoulder joint position sense (SJPS)
timeFrame: Baseline, 12 weeks
measure: Isometric strength measured by Constant Score - Isometric Maximal Voluntary Contraction (CS-iMVC)
timeFrame: Baseline, 12 weeks
measure: Apprehension and relocation tests
timeFrame: Baseline, 12 weeks
measure: Global Perceived Effect questionnaire (GPE)
timeFrame: at 12 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Bergen University College
Study officials:
affiliation: Western Norway University of Applied Sciences
name: Gro Anita F Flaten, ph.d.
role: STUDY_DIRECTOR
References:
citation: 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.