RecruitingACTRN12622000154707

Translation and validation of Victorian Institute of Sports Assessment for Gluteal Tendinopathy (VISA-G) questionnaire into Italian

Cross-cultural Adaptation and Measurement Properties of an Italian Version of the VISA-G questionnaire for Patients with Greater Trochanteric Pain Syndrome


Sponsor

University of L'Aquila

Enrollment

50 participants

Start Date

Apr 12, 2021

Study Type

Observational

Conditions

Summary

Greater trochanteric pain syndrome (GTPS) is a common, chronic, disabling, musculoskeletal condition characterised by intermittent or continuous pain at, or around, the greater trochanter of the femur. The condition can be debilitating enough to reduce activity and capacity for employment. The VISA-G, a condition-specific questionnaire, was developed for English-speaking patients. To date, no Italian version of the VISA-G exists.We believe that an Italian version of the VISA-G (VISA-G-I) questionnaire may help to guide clinical decision making and to understand and document the efficacy of treatment procedures in patients with GTPS. Before use in various regions of the world, outcome measures must be translated, culturally adapted, and retested to ensure the validity of the revised instrument. Therefore we decided to conduct this study whose purpose will be to translate the VISA-G from English into the Italian language, to conduct a cross-cultural adaptation into the Italian context, and to evaluate the VISA-G-I measurement properties.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

Greater trochanteric pain syndrome (GTPS) is a common condition causing persistent pain at the outer hip — often at the bony prominence you can feel on the side of your thigh. It is particularly prevalent in middle-aged women and overhead athletes, and can significantly interfere with walking, sleeping on the affected side, and daily activities. The VISA-G is a validated questionnaire used to measure the severity of GTPS and track treatment progress — but it currently exists only in English. This study is translating the VISA-G questionnaire into Italian, then carefully validating that the Italian version measures the same things as reliably as the original. The process involves not just translation, but cultural adaptation — ensuring the questions are understood the same way by Italian-speaking patients. You may be eligible if you are an Italian-speaking patient diagnosed with greater trochanteric pain syndrome. People with hip osteoarthritis, rheumatoid arthritis, nerve root problems from the spine, recent corticosteroid injections to the hip, or prior hip surgery are not eligible. While this is not a treatment trial, its outputs are practically significant: having a validated Italian-language VISA-G questionnaire will improve the ability of clinicians and researchers across Italian-speaking countries to assess and monitor GTPS, directly benefiting clinical decision-making and treatment research.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The purpose of the current study was to translate the VISA-G from English into the Italian language (VISA-G-IT), to conduct a cross-cultural adaptation into the Italian context, assessing validity in

The purpose of the current study was to translate the VISA-G from English into the Italian language (VISA-G-IT), to conduct a cross-cultural adaptation into the Italian context, assessing validity in the Italian context, and to evaluate the VISA-G-IT measurement properties. Translation procedure for the VISA-G questionnaire Beaton’s guidelines for the cross-cultural adaptation of self-reported measures were used (Beaton et al., 2000). In brief: 1. Permission. The developer of the VISA-G Dr. Angie Fearon from University of Canberra was approached by e-mail to requiring both her authorization and her availability to collaborate on the translation process into Italian language of VISA-G questionnaire (Fearon et al., 2015). Dr. Fearon promptly responded by giving us her authorization and willingness to collaborate on our project. 2. Forward translation. The English version of VISA-G will be independently translated into Italian by 2 non-medical professional translators whose native language is English and by a physician whose native language is Italian. Neither of the nonmedical translators are aware of the concepts being investigated or had a medical background. 3. Forward translation - Reconciliation. The 3 Italian translations will be analyzed by a healthcare committee (1 physiatrist, 2 epidemiologists, 1 physiotherapist), which will first ensure that the translations took Italian cultural characteristics into consideration. Discrepancies will be resolved by consensus to achieve conceptual equivalence. 4. Back translation - data acquisition. This consensus version (Italian version 1) will be translated back into English by another non-medical professional translator whose native language is English and that will be blinded to the purpose of the questionnaire and had not seen the original VISA-G questionnaire. 5. Back translation - Reconciliation. The back translated version will be compared to the original version to ensure conceptual equivalence; the remaining discrepancies and ambiguities were resolved between the project manager (AC) and developer (AF) 6. Harmonization. The harmonization group consisted of the back - and forward-translators, and the health committee. At the end the team will agree upon the harmonized version of the Italian VISA-G (VISA-G-IT) questionnaire. All members of the harmonization group will approve the translated versions. 7. Cultural validation. After the committee will confirm the equivalence of the original version and the Italian version of the VISA-G (VISA-G-IT), and the developer will approve the translation, we will perform a pilot test on 10 subjects with a diagnose of GTPS and 10 gender- and age-matched healthy subjects. The main aim of this phase will be to determine whether the subjects understood the questions. Cognitive interviews of 10 patients with a diagnose of GTPS, 10 gender- and age-matched healthy subjects 10 and a researcher and two physiotherapists with relevant clinical experience will conduct to assess the harmonised version of the VISA-G-IT. A researcher trained in cognitive interviewing will conduct these face-to-face interviews maximum 24 hours after each interviewee will completes the VISA-G-IT questionnaire. The time required to complete the questionnaire will take a maximum of 10 minutes, while the interview time will take a maximum of 30 minutes. Each interviewee will be asked whether there were sentences that were difficult to understand. They will be asked what they thought each question meant. The meaning of the items and tasks, as well as the selected responses, will be discussed. This will ensure that the prefinal version will retain adequate equivalence in purpose. All questions should be considered easily understandable by all subjects. 8. Cultural validation - Harmonization. The results from the previous process will be reviewed, and a final version of the VISA-G-IT questionnaire prepared. 9. Final Translation. The version will be proofread and checked for spelling and grammar errors. 10. Assessment of psychometric properties of VISA-G-IT questionnaire. In this phase a sample of convenience will be recruited at a physiotherapy private practice in L'Aquila, Italy. Based on an expected reliability of 0.90, assuming a power of 0.80 and a significance level of 0.05, we calculated that a total sample size of 49 patients with a diagnose of GTPS and 49 gender- and age-matched healthy subjects will be required for the assessment of psychometric properties of VISA-G-IT. Each patient and each healthy subject will be required to complete the VISA-G-IT and the Italian version of the Harris Hip Score questionnaire (HHS-IT) a first time (test) and then a second time after 3 days (re-test). These will allow to evaluate the psychometric properties (reliability and validity) of the VISA-G-IT questionnaire.


Locations(1)

Italy

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ACTRN12622000154707


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