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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05742152
Other study ID # B1152022000014
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2023
Est. completion date July 31, 2024

Study information

Verified date May 2024
Source Hasselt University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date July 31, 2024
Est. primary completion date June 24, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 and above, - Ambulatory pwMS with definite diagnosis based on McDonald criteria - Expanded Disability Status Scale of 6.0 or below, - Having pain in last month - Able to understand and answer the questions in the questionnaires. Exclusion Criteria: - Diagnosed with major musculoskeletal disorder and any neurological disorder other than MS, - a relapse in the last month before enrolment, - cognitive decline that renders the patient incapable of performing tests and questionnaires, - patients with only headache

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Belgium AZ Sint-Jan Brugge
Belgium National MS center Melsbroek Brabant
Belgium Noorderhart Overpelt Limburg
Chile Pontificia universidad catolica de Chile Santiago
Italy Galliera Hospital Genoa

Sponsors (1)

Lead Sponsor Collaborator
Hasselt University

Countries where clinical trial is conducted

Belgium,  Chile,  Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Douleur Neuropathique 4 (DN4) Questionnaire screening tool Day 1 and day 7
Secondary PainDETECT Questionnaire screening tool Day 1 and day 7
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