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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05742152
Enrollment
60
Registered
2023-02-23
Start date
2023-04-01
Completion date
2024-05-01
Last updated
2024-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Pain, outcome measure, assessment, multiple sclerosis, reliability, validity

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.

Interventions

None listed

Sponsors

Hasselt University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Douleur Neuropathique 4 (DN4) QuestionnaireDay 1 and day 7screening tool

Secondary

MeasureTime frameDescription
PainDETECT QuestionnaireDay 1 and day 7screening tool

Countries

Belgium, Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026