Clinical trial NCT06555991: Translation and Validation of the SIRSI and TSK-SI Into German
Official title: Translation and Validation of the Shoulder Instability Return to Sports Index (SIRSI) and Tampa Scale of Kinesiophobia Shoulder Instability (TSK-SI) Into German
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Shoulder Instability
Keywords: Return to Sports
Shoulder Instability
SIRSI
TSK-SI
Kinesiophobia
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Clinicians need to evaluate the psychological readiness to return to sports after an shoulder injury. The SIRSI is a questionnaire that provides such information, however it has not yet been translated and tested for a German speaking population (Switzerland, Austria or Germany). Similarily the TSK-SI is a questionnaire that measures fear of movement in patients with shoulderinstability, which is also not available to German speaking patients.

We conduct this study to translate both questionnaires into German and test it in German speaking patients in Switzerland.

Detailed description: Return to Sports (RTS) is an important outcome measure after shoulder instability treatment (Abdul-Rassoul et al., 2019). While the definition of returning to sport is not clear (Doege et al., 2021), efforts have been made to provide consensus. The concept of Return to Sport is multifactorial consisting of physical, psychological, and social/contextual factors in an interplay with sociodemographic and injury factors. Furthermore, different stages of RTS have been defined (Ardern et al., 2016). To take all factors into account, outcome measures like the ACL-RSI for anterior cruciate ligament ruptures have been invented (Webster et al., 2008). To provide such a measure for the shoulder instability cohort Gerometta et al (2018) have adapted the ACL-RSI to a shoulder instability population and named it the Shoulder Instability Return to Sport Index (SIRSI). Since then, this outcome has been frequently used to determine psychological readiness to RTS (Rossi et al., 2022). Despite an available German translation, published by a German insurance company (Return-to-Competition Schulter: Shoulder Instability-Return to Sport after Injury (SIRSI)-Skala (vbg.de), accessed 23.01.2024), the SIRSI is not scientifically available for a German speaking population, because this version has never been officially translated and validated. Similarly the Tampa Scale for Kinesiophobia (TSK) has been invented to measure an excessive fear of movement due to painful injury in chronic low back pain (Miller et al., 1991). The Scale was then adapted to the shoulder instability cohort (van Iersel et al., 2023). However, it is currently not available in German. Therefore, this project seeks to translate the SIRSI and TSK-SI into a German version and validate them in a German speaking population in Switzerland.

The aim of the project is to translate the Shoulder Instability Return to Sports Index (SIRSI) and Tampa Scale for Kinesiophobia - Shoulder Instability (TSK-SI) into a German version and assess its validity in a Swiss-German population of patients with shoulder instability treated conservatively or surgically and planning to return to sports.

Eligibility criteria: Inclusion Criteria:

1. Had an instability event within last year
2. Provided general consent for local shoulder instability register at Schulthess Klinik Zürich
3. Adult patients aged 18 or older

Exclusion Criteria:

1. Are at least three months after surgery or instability event
2. Must endeavor to return to their sport
3. Have another physical or psychological disorder not related to shoulder instability compromising return to sports
4. Have a language barrier to complete the questionnaires in German
5. Are legally incapable of participating in research studies

Primary outcomes:
measure: Shoulder Instability Return to Sports Index - German (SIRSI-D)
timeFrame: Baseline and after one week
measure: Tampa Scale for Kinesiophobia Shoulder Instability German (TSK-SI-D)
timeFrame: Baseline and after one week
Secondary outcomes:
measure: Western Ontario Shoulderinstability Index German (WOSI)
timeFrame: Baseline
measure: SSV and sSSV
timeFrame: Baseline
measure: Return to Sports Status
timeFrame: Baseline
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: Schulthess Klinik
Study officials:
affiliation: Schulthess Klinik Zürich
name: Asimina Lazaridou, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Iersel TP, Larsen van Gastel M, Versantvoort A, Hekman KMC, Sierevelt IN, Broekman BFP, van den Bekerom MPJ; Dutch Shoulder Instability Group (DSIG). The Modified Tampa-Scale of Kinesiophobia for Anterior Shoulder Instability. Arthrosc Sports Med Rehabil. 2023 Jul 24;5(4):100768. doi: 10.1016/j.asmr.2023.100768. eCollection 2023 Aug.
citation: Gerometta A, Klouche S, Herman S, Lefevre N, Bohu Y. The Shoulder Instability-Return to Sport after Injury (SIRSI): a valid and reproducible scale to quantify psychological readiness to return to sport after traumatic shoulder instability. Knee Surg Sports Traumatol Arthrosc. 2018 Jan;26(1):203-211. doi: 10.1007/s00167-017-4645-0. Epub 2017 Jul 13.