AzTrials
AzTrials

Hip Pain ChronicNCT04289922

Validation of the Norwegian VISA-G Questionnaire

An observational study of Hip Pain Chronic and Hip Bursitis, run by Oslo University Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hip Pain Chronic, Hip Bursitis
How many people
93 participants
Where
1 siteNorway
Study dates
8 Nov 2019to 5 Aug 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • Not able to read and write Norwegian
  • < 18 years old

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • Oslo University Hospital

    Oslo, 0450

Other trials in Norway

About this study

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

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.

Read the 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, 1 week, 7 weeks.

Secondary outcomes (4)

  1. 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.

    Measured: Baseline, 7 weeks

  2. 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.

    Measured: Baseline, 7 weeks

  3. 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.

    Measured: Baseline, 7 weeks

  4. 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.

    Measured: Baseline, 7 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2020
  2. Study start8 Nov 2019
  3. Primary completion5 Aug 2022
  4. Study completion5 Aug 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
93 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04289922
Sponsor's protocol ID
REK 2019/428 A
Status last verified
Nov 2022
First submitted
21 Feb 2020
Last updated
28 Nov 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 25870117

  • 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.

    PubMed 20169472

  • 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.

    PubMed 22588745

  • 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.

    PubMed 11124735

  • Sveinall H, Wenstad PK, Fearon AM, Skyttemyr G, Thornes E, Skaara HE, Juel NG, Brox JI, Roe C, Johnsen MB. The reliability and validity of the Norwegian version of the Victorian Institute of Sports Assessment for gluteal tendinopathy questionnaire (VISA-G-Norwegian) for patients with greater trochanteric pain syndrome. BMC Musculoskelet Disord. 2023 Sep 29;24(1):769. doi: 10.1186/s12891-023-06901-0.

    PubMed 37770944

Questions about this trial

What is this clinical trial studying?

An observational study of Hip Pain Chronic and Hip Bursitis, run by Oslo University Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

VISA-N-G (time frame: Baseline, 1 week, 7 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04289922, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in