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CompletedNCT05742152Updated Jul 12, 2024

Reliability and Validity of Outcome Measures for Pain in Multiple Sclerosis

An observational study in Pain, sponsored by Hasselt University. Completed at 4 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-12.

Sponsored by Hasselt University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Pain

Keywords

  • Pain, outcome measure, assessment, multiple sclerosis, reliability, validity
03

In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's enrollment of 60 is below the median of 100 across 301 observational studies indexed under Pain.

Browse Pain studies →

Lead sponsor

Hasselt University is the lead sponsor of 203 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

People with MS with pain

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Douleur Neuropathique 4 (DN4) Questionnaire

    screening tool

    Time frame: Day 1 and day 7

Secondary outcomes

  1. PainDETECT Questionnaire

    screening tool

    Time frame: Day 1 and day 7

07

Study locations

4 sites
  • National MS center
    Melsbroek, Brabant 1820, Belgium
  • Noorderhart
    Overpelt, Limburg 3900, Belgium
  • AZ Sint-Jan
    Bruges, Belgium
  • Pontificia universidad catolica de Chile
    Santiago, Chile
08

References and documents

Publications

  • Yilmazer C, D'haeseleer M, Soler B, Van Wijmeersch B, Solaro C, Ciampi E, Carcamo C, Van Asch P, Cambron M, Lamers I, Feys P. Assessing pain in multiple sclerosis: Test-retest reliability of patient-reported outcome measures and accuracy of screening tools. Mult Scler. 2025 Apr;31(4):474-488. doi: 10.1177/13524585241310139. Epub 2025 Jan 16. PubMed 39819131 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Apr 2023 to primary completion in Apr 2024, 12 months.

Of 147 non-industry observational studies under Pain, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 71. This study's 12 months is below that.

Counting every sponsor, half of 154 studies reached it within 23 months; a quarter within 11 and three quarters within 71.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 28, 2023
First posted
Feb 23, 2023
StartActual
Apr 1, 2023
Primary completionActual
Apr 23, 2024
CompletionActual
May 1, 2024
Last update
Jul 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05742152
Lead sponsor
Hasselt University
Responsible party
Peter Feys (Prof. dr., Hasselt University) — Principal investigator
First posted
Feb 23, 2023
Start date
Apr 1, 2023
Primary completion
Apr 23, 2024
Completion
May 1, 2024
Last update
Jul 12, 2024

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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