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Completed

NCT Number: NCT04289922

Validation of the Norwegian VISA-G Questionnaire

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0450, Norway

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. VISA-N-G

    Time frame: Baseline, 1 week, 7 weeks.

    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 GTPS populations.The VISA-G questionnaire is based on other Health-related patient-reported outcomes (HR-PROs) from Victorian Institute of Sports tendon study Group. The investigators will test the construct validity with two other HR-PROs (Harris Hip Score and Oswestry disability index). To investigate test-retest reliability, the patients will fill out a second VISA-N-G one week after baseline. To test responsiveness, the patients will fill out VISA-N-G 7 weeks after baseline together with the two other HR-PROs, and a Global Rating of Change scale.

Secondary outcomes

  1. Harris Hip Score

    Time frame: Baseline, 7 weeks

    Harris Hip Score (HHS) is an HR-PROs questionnaire used for assessing outcome after total hip replacement, femoral neck fractures and osteoarthritis. It is expected to take 5 minutes to complete and is based on 10 items. It is scored from 0 to 100, where 100 is the best outcome, <70 is considered a poor result. HHS has shown to be a responsive measure and shows a strong correlation in the physical domain of The short form Health survey (SF36) and high correlation to the Nottingham Health Profile.

  2. Oswestry disability index

    Time frame: Baseline, 7 weeks

    Oswestry disability index (ODI) is a widely used HR-PROs used for spinal disorders. Its asking about the patients perceived disability and is scored from 0 to 100%, where 0% indicates no disability and 100% indicates most disability. ODI is cross-cultural adapted into Norwegian and psychometric properties was concluded acceptable for assessing self-reported functional status of Norwegian-speaking patients with low back pain.

  3. Numeric rating scale

    Time frame: Baseline, 7 weeks

    In a Numeric rating scale (NRS) the patients rate their pain intensity between 0 and 10. Zero represents "no pain at all" and 10 represents "the worst pain ever possible". NRS correlates highly to other pain assessment tools. A change of two points is detected as being clinically significant. In this project the investigator will ask for the patient's current pain, average pain the last week, worst pain last week, and least pain last week.

  4. Global Rating of Change scale

    Time frame: Baseline, 7 weeks

    A Global Rating of Change scale (GROC) scale is designed to quantify a patient's improvement or worsening over time, the scale ask about the current and previous health status and then calculates the difference. The scale is "global" and allows the patient themselves to subjectively decide their health status. Scales between 7 and 11 seems to be the compromise between patient preference, adequate discriminative ability and test-retest reliability. The investigator will use an 11-point scale from - 5 to 5 where - 5 = worsening, 0 = unchanged and 5 = completely recovered. An 11-point scale has shown test-retest reliability with ICC 0.90, minimum detectable change of 0.45 points and minimally clinically important change 2 points.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Cross-cultural Adaption and Validation of the Norwegian VISA-G Questionnaire for Patients With Hip Pain

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Feb 28, 2020
Registry last updated
Nov 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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