NCT04289922

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 8, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 5, 2022

Completed
Last Updated

November 28, 2022

Status Verified

November 1, 2022

Enrollment Period

2.7 years

First QC Date

February 21, 2020

Last Update Submit

November 24, 2022

Conditions

Outcome Measures

Primary Outcomes (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.

    Baseline, 1 week, 7 weeks.

Secondary Outcomes (4)

  • Harris Hip Score

    Baseline, 7 weeks

  • Oswestry disability index

    Baseline, 7 weeks

  • Numeric rating scale

    Baseline, 7 weeks

  • Global Rating of Change scale

    Baseline, 7 weeks

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0450, Norway

Location

Related Publications (5)

  • 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.

    PMID: 25870117BACKGROUND
  • 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.

    PMID: 20169472BACKGROUND
  • 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.

    PMID: 22588745BACKGROUND
  • 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.

    PMID: 11124735BACKGROUND
  • 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.

Study Officials

  • Marianne B Johnsen, PT, MSc, PhD

    Oslo University Hospital, Department of Physical Medicine and Rehabilitation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 21, 2020

First Posted

February 28, 2020

Study Start

November 8, 2019

Primary Completion

August 5, 2022

Study Completion

August 5, 2022

Last Updated

November 28, 2022

Record last verified: 2022-11

Locations