Reliability and Validity of Outcome Measures for Pain in Multiple Sclerosis

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05742152
• Other study ID #: B1152022000014
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: July 31, 2024

Study information

• Verified date: May 2024
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 31, 2024
• Est. primary completion date: June 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Pain
• Sclerosis

Locations

Country	Name	City	State
Belgium	AZ Sint-Jan	Brugge
Belgium	National MS center	Melsbroek	Brabant
Belgium	Noorderhart	Overpelt	Limburg
Chile	Pontificia universidad catolica de Chile	Santiago
Italy	Galliera Hospital	Genoa

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Countries where clinical trial is conducted

Belgium,  Chile,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Douleur Neuropathique 4 (DN4) Questionnaire	screening tool	Day 1 and day 7
Secondary	PainDETECT Questionnaire	screening tool	Day 1 and day 7