Clinical trial NCT05742152: Reliability and Validity of Outcome Measures for Pain in Multiple Sclerosis
Official title: Between-day Reliability and Concurrent Validity of Outcome Measures for Pain in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Keywords: Pain, outcome measure, assessment, multiple sclerosis, reliability, validity
Lead sponsor: Hasselt University
Sponsor class: OTHER
First posted: 2023-02-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People with MS with pain

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.

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

Primary outcomes:
measure: Douleur Neuropathique 4 (DN4) Questionnaire
timeFrame: Day 1 and day 7
Secondary outcomes:
measure: PainDETECT Questionnaire
timeFrame: Day 1 and day 7
Other outcomes:
Locations:
city: Melsbroek
country: Belgium
facility: National MS center
state: Brabant
city: Overpelt
country: Belgium
facility: Noorderhart
state: Limburg
city: Brugge
country: Belgium
facility: AZ Sint-Jan
city: Santiago
country: Chile
facility: Pontificia universidad catolica de Chile
Study officials:
References: