Clinical Trials Directory

Trials / Completed

CompletedNCT05742152

Reliability and Validity of Outcome Measures for Pain in Multiple Sclerosis

Between-day Reliability and Concurrent Validity of Outcome Measures for Pain in Multiple Sclerosis

Status
Completed
Phase
Study type
Observational
Enrollment
60 (actual)
Sponsor
Hasselt University · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This project aims to provide values of test-retest reliability and insights from concurrent validity of outcome measures for pain in multiple sclerosis.

Detailed description

Pain is one of the most annoying symptoms in multiple sclerosis (MS). However, it is underestimated albeit its high prevalence rate with 63%. It negatively affects health related quality of life, activity of daily living, mental health, social functioning, employment, sleep and life enjoyment. In literature, the prevalence of pain varies in the MS literature from 29% to 86%. This wide-range prevalence is the result of methodological differences and non-uniformity of the studied populations which makes pain unclear and underdiagnosed in multiple sclerosis.It is hypothesized that the consistency, severity and interference of pain have varying relationships between other factors such as depression, anxiety, sleep or fatigue. Evaluating pain was done with various outcome measures resulting in inconclusive results. However, very few of the pain outcome measures are validated for MS population. Thus, it cannot be advised yet whether they contain similar or complementary information. Finally, the interference of pain on activities and participation level of the International Classification of Functioning, Disability and Health (ICF) is poorly documented. This project aims to put the foundations for future interventional research by providing values of test-retest reliability and insights from concurrent validity. As well, the perceived interference from pain on activities and participation level will be documented.

Conditions

Timeline

Start date
2023-04-01
Primary completion
2024-04-23
Completion
2024-05-01
First posted
2023-02-23
Last updated
2024-07-12

Locations

4 sites across 2 countries: Belgium, Chile

Source: ClinicalTrials.gov record NCT05742152. Inclusion in this directory is not an endorsement.