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Clinical Trials/NCT05742152
NCT05742152
Completed
Not Applicable

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

Hasselt University4 sites in 2 countries60 target enrollmentApril 1, 2023
ConditionsPain

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Hasselt University
Enrollment
60
Locations
4
Primary Endpoint
Douleur Neuropathique 4 (DN4) Questionnaire
Status
Completed
Last Updated
last year

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
May 1, 2024
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Hasselt University
Responsible Party
Principal Investigator
Principal Investigator

Peter Feys

Prof. dr.

Hasselt University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Douleur Neuropathique 4 (DN4) Questionnaire

Time Frame: Day 1 and day 7

screening tool

Secondary Outcomes

  • PainDETECT Questionnaire(Day 1 and day 7)

Study Sites (4)

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