- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04289922
Validation of the Norwegian VISA-G Questionnaire
Cross-cultural Adaption and Validation of the Norwegian VISA-G Questionnaire for Patients With Hip Pain
Study Overview
Status
Conditions
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Oslo, Norway, 0450
- Oslo University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VISA-N-G
Time Frame: Baseline, 1 week, 7 weeks.
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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.
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Baseline, 1 week, 7 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Harris Hip Score
Time Frame: Baseline, 7 weeks
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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.
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Baseline, 7 weeks
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Oswestry disability index
Time Frame: Baseline, 7 weeks
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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.
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Baseline, 7 weeks
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Numeric rating scale
Time Frame: Baseline, 7 weeks
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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.
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Baseline, 7 weeks
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Global Rating of Change scale
Time Frame: Baseline, 7 weeks
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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.
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Baseline, 7 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Marianne B Johnsen, PT, MSc, PhD, Oslo University Hospital, Department of Physical medicine and rehabilitation
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- REK 2019/428 A
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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