Reliability and Validity of Outcome Measures for Pain in Multiple Sclerosis

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

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Key information

Conditions

Pain Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National MS center, Melsbroek, Brabant, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Douleur Neuropathique 4 (DN4) Questionnaire

Time frame: Day 1 and day 7

screening tool

Secondary outcomes

PainDETECT Questionnaire

Time frame: Day 1 and day 7

screening tool

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Feb 23, 2023
Registry last updated: Jul 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed