Reliability and Validity of Outcome Measures for Pain in Multiple Sclerosis

Sponsor

Hasselt University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05742152

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Outcome Measures

Primary Outcome Measures

Douleur Neuropathique 4 (DN4) Questionnaire [Day 1 and day 7]
screening tool

Secondary Outcome Measures

PainDETECT Questionnaire [Day 1 and day 7]
screening tool

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age between 18 and 65 years,
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 headache

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Hasselt University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Peter Feys, Prof. dr., Hasselt University

ClinicalTrials.gov Identifier:

NCT05742152

Other Study ID Numbers:

B1152022000014

First Posted:

Feb 23, 2023

Last Update Posted:

Feb 23, 2023

Last Verified:

Feb 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Peter Feys, Prof. dr., Hasselt University

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

Additional relevant MeSH terms:

Multiple Sclerosis

Sclerosis

Study Results

No Results Posted as of Feb 23, 2023