Reliability and Validity of Outcome Measures for Pain in Multiple Sclerosis

July 11, 2024 updated by: Peter Feys, Hasselt University

Between-day Reliability and Concurrent 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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brugge, Belgium
        • AZ Sint-Jan
    • Brabant
      • Melsbroek, Brabant, Belgium, 1820
        • National MS center
    • Limburg
      • Overpelt, Limburg, Belgium, 3900
        • Noorderhart
  • Chile
      • Santiago, Chile
        • Pontificia Universidad Catolica de Chile

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

People with MS with pain

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Douleur Neuropathique 4 (DN4) Questionnaire
Time Frame: Day 1 and day 7
screening tool
Day 1 and day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PainDETECT Questionnaire
Time Frame: Day 1 and day 7
screening tool
Day 1 and day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasselt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Actual)

April 23, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

January 28, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 23, 2023

Study Record Updates

Last Update Posted (Actual)

July 12, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B1152022000014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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