Translation and Validation of the SIRSI and TSK-SI Into German

August 28, 2025 updated by: Schulthess Klinik

Translation and Validation of the Shoulder Instability Return to Sports Index (SIRSI) and Tampa Scale of Kinesiophobia Shoulder Instability (TSK-SI) Into German

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.

This study is conducted to translate both questionnaires into German and test it in German speaking patients in Switzerland.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

87

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Zurich, Switzerland, 8008
        • Schulthess Klinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: SIRSI and TSK-SI
The SIRSI and TSK-SI as well as the WOSI and RTS-, Clinical- and Demographic Information are gathered. The SIRSI and TSK-SI are re-administered one week later
The SIRSI and TSK-SI as well as the WOSI and RTS-, Clinical- and Demographic Information are gathered. The SIRSI and TSK-SI are re-administered one week later

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder Instability Return to Sports Index - German (SIRSI-D)
Time Frame: Baseline and after one week
The SIRSI has been adapted to the shoulder instability cohort from the Anterior Cruciate Ligament Return to Sport Index (ACL-RSI) by (Gerometta et al., 2018). It is composed of twelve items that are rated on a zero to ten. The single total score is calculated by multiplying the sum of each item and dividing it by 120. The worst score then is zero indicating no psychological readiness to RTS and 100 the best, indicating full psychological readiness to RTS.
Baseline and after one week
Tampa Scale for Kinesiophobia Shoulder Instability German (TSK-SI-D)
Time Frame: Baseline and after one week
The TSK-SI has been adapted to the shoulder cohort by van Iersel et al (2023). The TSK-SI is composed of 18 questions scored on a 4 point Likert-Scale from "Strongly agree" to "Strongly disagree". The lowest score is 18, indicating no kinesiophobia and 72, indicating highest level of kinesiophobia.
Baseline and after one week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario Shoulderinstability Index German (WOSI)
Time Frame: Baseline
The the Western Ontario Shoulderinstability Index (WOSI) was developed by Kirkley (2003) and is the most prominent PROM in clinic and research for shoulder instability. The WOSI consists of 21 items and four domains: Physical symptoms (10 items), Sports, recreation, and work (4 items), lifestyle (4 items) and emotions (3 items). The scale for each item ranges from 0 to 100, allowing for a total score of 0 (best) to 2100 (worst).
Baseline
Return to Sports Status
Time Frame: Baseline
Ardern et al (2016) defined RTS as that the athlete has returned to his previous sport but not necessarily at the same performance level and differentiated it to return to participation and return to performance. This spectrum will be assessed using custom build questions to determine the RTS level
Baseline
SSV
Time Frame: Baseline
The subjective shoulder value (SSV) was introduced by Gilbart and Gerber (2007) and provides a simple measure to represent shoulder functionality during activities of daily living (ADL). Patients are asked to rate their overall shoulder state on a scale from 0 to 100 percent, where a healthy shoulder is 100 percent. The scale results in a value between zero and 100, where zero means no subjective functionality during ADLs.
Baseline
sSSV
Time Frame: Baseline
Because the standard SSV might lack sport specific context Descamps et al (2023) suggested the sport subjective shoulder value (sSSV) with the question "Regarding sports practice, what is the overall percent value of your shoulder, if a completely normal shoulder represents 100% and a non-functional shoulder represents 0%?". The scale results in a value between zero and 100, where zero means no subjective functionality during sport.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Asimina Lazaridou, PhD, Schulthess Klinik Zürich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Actual)

May 31, 2025

Study Completion (Actual)

May 31, 2025

Study Registration Dates

First Submitted

August 6, 2024

First Submitted That Met QC Criteria

August 12, 2024

First Posted (Actual)

August 15, 2024

Study Record Updates

Last Update Posted (Estimated)

August 29, 2025

Last Update Submitted That Met QC Criteria

August 28, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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