Clinical trial NCT04289922: Validation of the Norwegian VISA-G Questionnaire
Official title: Cross-cultural Adaption and Validation of the Norwegian VISA-G Questionnaire for Patients With Hip Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hip Pain Chronic
Hip Bursitis
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients included in our project is referred to the Department of Physical Medicine and Rehabilitation through a primary contact in the primary health care i.e. medical doctors, manual therapists or chiropractors, or from other doctors within the specialist healthcare settings for example a rheumatologists or orthopaedic surgeons. The investigators will record information on age, gender, education and work status in addition to data from the included questionnaires.

Brief summary: The aim of this study is to translate, cross-cultural adapt and validate the Norwegian VISA-G (VISA-N-G) questionnaire. The study will test the psychometric properties for the VISA-N-G in terms of test-retest reliability, internal consistency, construct validity and responsiveness.

Detailed description: The Victorian Institute of Sport Assessment-Gluteal Questionnaire (VISA-G) questionnaire have already been developed and used as a measurement tool in research on English speaking Greater trochanteric pain syndrome (GTPS) populations.

The aim of this study is to translate, cross-cultural adapt and validate the Norwegian VISA-G (VISA-N-G) questionnaire.

The translation of the original VISA-G into Norwegian has been done following the official guidelines.

The patients will be recruited from the outpatient clinic at the Department of Physical Medicine and Rehabilitation, Oslo University Hospital and will follow the ordinary patient care.

After given written consent, patients will be asked to fill out the following Norwegian questionnaires: VISA-N-G, Harris Hip Score (HHS), Oswestry disability index (ODI) and a numeric rating scale (NRS) for assessment of pain intensity. The aforementioned questionnaires will be used to test the construct validity with various hypothesis at baseline. Within one week the investigators will ask the patients to fill out the VISA-N-G once more to test the test-retest reliability.

To investigate responsiveness the patient will be asked to fill out the VISA-N-G together With HHS, ODI, NRS and a 11-Point Global Rating of Change scale (GROC) after seven weeks. Responsiveness will be tested with various hypothesis and measured by the area under the receiver operating characteristics curve (ROC).

Eligibility criteria: Inclusion Criteria:

* Hip pain
* Ability to read and write Norwegian
* \> 18 years old

Exclusion criteria:

* Not able to read and write Norwegian
* \< 18 years old

Primary outcomes:
measure: VISA-N-G
timeFrame: Baseline, 1 week, 7 weeks.
Secondary outcomes:
measure: Harris Hip Score
timeFrame: Baseline, 7 weeks
measure: Oswestry disability index
timeFrame: Baseline, 7 weeks
measure: Numeric rating scale
timeFrame: Baseline, 7 weeks
measure: Global Rating of Change scale
timeFrame: Baseline, 7 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital, Department of Physical Medicine and Rehabilitation
name: Marianne B Johnsen, PT, MSc, PhD
role: STUDY_DIRECTOR
References:
citation: Fearon AM, Ganderton C, Scarvell JM, Smith PN, Neeman T, Nash C, Cook JL. Development and validation of a VISA tendinopathy questionnaire for greater trochanteric pain syndrome, the VISA-G. Man Ther. 2015 Dec;20(6):805-13. doi: 10.1016/j.math.2015.03.009. Epub 2015 Apr 2.
citation: Mokkink LB, Terwee CB, Patrick DL, Alonso J, Stratford PW, Knol DL, Bouter LM, de Vet HC. The COSMIN checklist for assessing the methodological quality of studies on measurement properties of health status measurement instruments: an international Delphi study. Qual Life Res. 2010 May;19(4):539-49. doi: 10.1007/s11136-010-9606-8. Epub 2010 Feb 19.
citation: Nilsdotter A, Bremander A. Measures of hip function and symptoms: Harris Hip Score (HHS), Hip Disability and Osteoarthritis Outcome Score (HOOS), Oxford Hip Score (OHS), Lequesne Index of Severity for Osteoarthritis of the Hip (LISOH), and American Academy of Orthopedic Surgeons (AAOS) Hip and Knee Questionnaire. Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S200-7. doi: 10.1002/acr.20549. No abstract available.
citation: Beaton DE, Bombardier C, Guillemin F, Ferraz MB. Guidelines for the process of cross-cultural adaptation of self-report measures. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3186-91. doi: 10.1097/00007632-200012150-00014. No abstract available.