Reliability and Validity of Outcome Measures for Pain in Multiple Sclerosis

Completed

• Conditions: Pain

• Registration Number: NCT05742152
• Lead Sponsor: Hasselt University

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.

Study Timeline

• Study First Submitted: 2023-01-28
• Study First Submitted QC: 2023-02-14
• Study First Posted: 2023-02-23
• Study Start: 2023-04-01
• Primary Completion: 2024-04-23
• Study Completion: 2024-05-01
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-11
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Douleur Neuropathique 4 (DN4) Questionnaire	Day 1 and day 7	screening tool

Secondary Outcome Measures

Name	Time	Method
PainDETECT Questionnaire	Day 1 and day 7	screening tool

Trial Locations

Locations (4)

AZ Sint-Jan; 🇧🇪 Brugge, Belgium

Noorderhart; 🇧🇪 Overpelt, Limburg, Belgium

National MS center; 🇧🇪 Melsbroek, Brabant, Belgium

Pontificia universidad catolica de Chile; 🇨🇱 Santiago, Chile