PainNCT05742152
Reliability and Validity of Outcome Measures for Pain in Multiple Sclerosis
An observational study of Pain, run by Hasselt University at 4 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- How many people
- 60 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Apr 2023to 1 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People with MS with pain
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Belgium3 sites
AZ Sint-Jan
Bruges
National MS center
Melsbroek, Brabant, 1820
Noorderhart
Overpelt, Limburg, 3900
About this study
Official title: 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.
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.
- Conditions
- Pain
- Keywords
- Pain, outcome measure, assessment, multiple sclerosis, reliability, validity
- Medical subject headings
- Pain, Multiple Sclerosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Douleur Neuropathique 4 (DN4) Questionnaire
screening tool
Measured: Day 1 and day 7
Secondary outcomes (1)
PainDETECT Questionnaire
screening tool
Measured: Day 1 and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Apr 2023
- Primary completion23 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hasselt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Feys, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742152
- Sponsor's protocol ID
- B1152022000014
- Status last verified
- Jul 2024
- First submitted
- 28 Jan 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Between-day Reliability and Concurrent Validity of Outcome Measures for Pain in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05742152
- Acronym / sponsor ID
- B1152022000014
- Conditions
- Pain
- Keywords
- Pain, outcome measure, assessment, multiple sclerosis, reliability, validity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hasselt UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with MS with pain
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Douleur Neuropathique 4 (DN4) Questionnaire
Time frame: Day 1 and day 7
screening tool
1 secondary outcome
PainDETECT Questionnaire
Time frame: Day 1 and day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Derived from this study: PubMed 39819131Yilmazer 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Hasselt University at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Douleur Neuropathique 4 (DN4) Questionnaire (time frame: Day 1 and day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05742152, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.