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Shoulder InstabilityNCT06555991

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

A study testing SIRSI and TSK-SI in people with Shoulder Instability, run by Schulthess Klinik at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Shoulder Instability
What is being tested?
SIRSI and TSK-SI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteSwitzerland
Study dates
1 Aug 2024to 31 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Schulthess Klinik

    Zurich, 8008

Other trials in Switzerland

About this study

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

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.

Read the 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.

Being tested
SIRSI and TSK-SI
Keywords
Return to Sports, Shoulder Instability, SIRSI, TSK-SI, Kinesiophobia
Medical subject headings
Kinesiophobia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SIRSI and TSK-SIOther

    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

Study groups in NCT06555991
Study groupRoleWhat they receive
SIRSI and TSK-SIOtherThe 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
Receives: Other: SIRSI and TSK-SI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Shoulder Instability Return to Sports Index - German (SIRSI-D)

    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.

    Measured: Baseline and after one week

  2. Tampa Scale for Kinesiophobia Shoulder Instability German (TSK-SI-D)

    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.

    Measured: Baseline and after one week

Secondary outcomes (4)

  1. Western Ontario Shoulderinstability Index German (WOSI)

    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).

    Measured: Baseline

  2. SSV

    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.

    Measured: Baseline

  3. sSSV

    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.

    Measured: Baseline

  4. Return to Sports Status

    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

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2024
  2. Study start1 Aug 2024
  3. Primary completion31 May 2025
  4. Study completion31 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06555991
Sponsor's protocol ID
OE-236
Status last verified
Aug 2025
First submitted
6 Aug 2024
Last updated
29 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 37645388

  • 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.

    PubMed 28707114

Questions about this trial

What is this clinical trial studying?

A study testing SIRSI and TSK-SI in people with Shoulder Instability, run by Schulthess Klinik at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Shoulder Instability Return to Sports Index - German (SIRSI-D) (time frame: Baseline and after one week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06555991, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2025.

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