Validation of the Norwegian VISA-G Questionnaire

Hip Pain Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04289922
• Other study ID #: REK 2019/428 A
• Status: Completed
• Start date: November 8, 2019
• Est. completion date: August 5, 2022

Study information

• Verified date: November 2022
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: August 5, 2022
• Est. primary completion date: August 5, 2022
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bursitis
• Hip Bursitis
• Hip Pain Chronic

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VISA-N-G	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.	Baseline, 1 week, 7 weeks.
Secondary	Harris Hip Score	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.	Baseline, 7 weeks
Secondary	Oswestry disability index	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.	Baseline, 7 weeks
Secondary	Numeric rating scale	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.	Baseline, 7 weeks
Secondary	Global Rating of Change scale	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.	Baseline, 7 weeks