Multiple SclerosisNCT07766213
Pain Phenotypes in Individuals With Multiple Sclerosis
An observational study of Multiple Sclerosis and Chronic Pain, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
This observational cross-sectional study aims to determine chronic pain phenotypes in individuals with multiple sclerosis (MS) and to investigate the clinical characteristics associated with different pain phenotypes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Chronic Pain
- What is being tested?
- Pain classification method
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2026to 15 Sep 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Participants meeting the inclusion criteria will be taken for this cross-sectional study. Individuals with MS who apply to Kutahya Health Sciences University Hospital Physiotherapy Department will be screened for eligibility by their clinic physicians and will then be asked to participate in this study.
Who may be able to join
- Age 18 years or older
- Definite diagnosis of multiple sclerosis according to the McDonald criteria
- No MS relapse or high-dose steroid treatment within the previous 3 months
- Pain intensity ≥2 on the Numeric Rating Scale in at least one body region for at least 3 months
- Ability to read, understand, and communicate in Turkish
Who cannot join
- Pregnancy
- Severe psychiatric disorder and/or severe cognitive impairment confirmed by a neurologist or neuropsychiatrist
- Presence of a serious pathology or disease that may compromise the assessment process or affect clinical decision-making, including metastasis, cancer, untreated or unhealed fractures, neurological disorders other than multiple sclerosis, or a history of diabetes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Kutahya Health Sciences University Physical Medicine and Rehabilitation Department
Kütahya, Turkiye, 43100
Ismail SARACOGLU, Head of Department, 002742651300 ext. 1499, ismail.saracoglu@ksbu.edu.tr
Nisa TURUTGEN, Msc.
About this study
Official title: Pain Phenotyping in Multiple Sclerosis Based on IASP Criteria
This observational cross-sectional study aims to determine chronic pain phenotypes in individuals with multiple sclerosis (MS) and to investigate the clinical characteristics associated with different pain phenotypes. Participants with MS and chronic pain will undergo a comprehensive clinical assessment to identify nociceptive, neuropathic, nociplastic, and mixed pain phenotypes. The assessment will include clinical history, pain characteristics and distribution, quantitative sensory testing, pain intensity, disease severity, fatigue, health-related quality of life, and pain catastrophizing. The clinical characteristics of participants with different pain phenotypes will subsequently be compared.
Read the detailed description
Multiple sclerosis (MS) is a chronic, progressive, autoimmune disease of the central nervous system characterized by inflammatory demyelination and axonal damage. Pain is common among individuals with MS and may substantially affect functioning and quality of life. Different pain mechanisms may coexist in individuals with MS; however, the contribution of nociceptive, neuropathic, nociplastic, and mixed pain phenotypes in this population remains insufficiently characterized.
This cross-sectional observational study will include individuals with a definite diagnosis of MS who experience chronic pain. Participants will undergo a comprehensive clinical assessment to determine their predominant pain phenotype. Pain phenotyping will incorporate clinical history, pain characteristics and distribution, hypersensitivity findings, comorbidities, and quantitative sensory testing.
Quantitative sensory testing will include static tactile mechanical detection, thermal perception, static mechanical allodynia, dynamic mechanical allodynia, and vibration perception. Testing will be performed under standardized environmental conditions and initially at the participant's most painful body region.
In addition to pain phenotyping, pain intensity, pain distribution, pain catastrophizing, fatigue, health-related quality of life, and MS disease severity will be evaluated. Clinical characteristics will subsequently be compared among participants with different pain phenotypes to investigate the potential clinical impact of pain mechanisms in individuals with MS.
- Conditions
- Multiple Sclerosis, Chronic Pain
- Being tested
- Pain classification method
- Keywords
- CHRONIC PAIN, NEUROPATHIC PAIN, NOCIPLASTIC PAIN, MULTIPLE SCLEROSIS
- Medical subject headings
- Multiple Sclerosis, Chronic Pain, Neuralgia, Nociplastic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain classification methodDiagnostic test
A current clinical algorithm will be used to determine the predominant type of pain in individuals with MS. The classification to diagnose nociceptive, neuropathic and nociplastic pain will based on a recent method developed by Nijs et al. This method consists of seven steps in total. These steps question the following, respectively: duration of pain, pain distribution, presence of nociceptive pain, presence of neuropathic pain, phenomenon of hypersensitivity, presence of hypersensitization and presence of specific comorbidity. Besides, inter-rater and intra-rater reliability of pain classification algorithm will be determined by two independent researchers.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative sensory test: static tactile mechanical threshold
Von Frey Monofilaments (2 gr- 26 gr) will be used assessment for the static tactile mechanical detection threshold.
Measured: 10 minutes
Quantitative sensory test: hot-cold pain threshold
Coins will be used for the hot-cold pain threshold. The cold sensing test will be done with a coin held at room temperature. The hot sensing test will be done in the form of a coin placed in the pocket and applied to the participant after waiting for 30 minutes.
Measured: 5 minutes
Quantitative sensory test: static mechanical allodynia
A digital algometer device (JTech) will be used for static mechanical allodynia (pressure pain threshold). In the device, the pain sensation will be tested by applying 4 kg of pressure to the participant.
Measured: 5 minutes
Quantitative sensory test: dynamic mechanical allodynia
A soft brush will be used for dynamic mechanical allodynia. The brush will be gently moved over the skin at a speed of 3-5 cm per second in a fixed direction over the patients primary painful area.
Measured: 5 minutes
Quantitative sensory test: vibration sense
128 Hz tuning fork will be used in vibration assessment. The device will be applied over the bony prominences in the painful area of the patient.
Measured: 5 minutes
Margolis Pain Diagram
The Margolis Pain Diagram, consists of a dorsal and a ventral drawing body, is used to assess the location and distribution of the pain [20]. Participants will ask to point out the place where they experience pain during the preceding 4 weeks for at least 24 hours.
Measured: 1 minute
Secondary outcomes (8)
Numeric Pain Rating Scale
Pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS). Participants will rate their pain intensity from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity.
Measured: 1 minute
Pain Catastrophizing Scale (PCS)
Pain catastrophizing will be assessed using the 13-item Pain Catastrophizing Scale (PCS). The scale evaluates three dimensions of pain catastrophizing: rumination, helplessness, and magnification. Each item is scored from 0 to 4, resulting in a total score ranging from 0 to 52. Higher scores indicate greater pain catastrophizing.
Measured: 5 minutes
Modified Fatigue Impact Scale (MFIS)
Fatigue will be assessed using the Modified Fatigue Impact Scale (MFIS). The MFIS evaluates the perceived impact of fatigue on physical, cognitive, and psychosocial functioning. It consists of 21 items scored on a 5-point Likert scale from 0 to 4, resulting in a total score ranging from 0 to 84. Higher scores indicate a greater impact of fatigue on daily functioning. Physical, cognitive, and psychosocial subscale scores may also be calculated separately.
Measured: 1 minute
Health-Related Quality of Life
Health-related quality of life will be assessed using the Short Form-12 Health Survey (SF-12). The questionnaire consists of 12 items and provides physical and mental component scores. Higher scores indicate better health-related quality of life.
Measured: 5 minutes
Multiple Sclerosis Disease Severity
Multiple sclerosis-related neurological disability and disease severity will be assessed using the Expanded Disability Status Scale (EDSS). The EDSS evaluates neurological impairment and disability associated with MS, with higher scores indicating greater neurological disability.
Measured: 5 minutes
Overactive Bladder Questionnaire-V8 (OAB-V8)
Overactive bladder symptoms will be assessed using the Overactive Bladder Questionnaire-V8 (OAB-V8). The questionnaire consists of 8 items evaluating the degree of bother associated with symptoms such as urinary urgency, frequency, nocturia, and urge urinary incontinence. Higher total scores indicate greater symptom burden related to overactive bladder.
Measured: 5 minutes
Hospital Anxiety and Depression Scale (HADS)
Anxiety and depressive symptoms will be assessed using the Hospital Anxiety and Depression Scale (HADS). The scale consists of 14 items divided into two 7-item subscales: the Hospital Anxiety and Depression Scale-Anxiety (HADS-A) and the Hospital Anxiety and Depression Scale-Depression (HADS-D). Each item is scored from 0 to 3, resulting in subscale scores ranging from 0 to 21. Higher scores indicate greater anxiety or depressive symptom severity.
Measured: 5 minutes
Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
Cognitive function will be assessed using the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS), a standardized cognitive assessment battery developed for individuals with multiple sclerosis. The battery includes the Symbol Digit Modalities Test (SDMT) for information processing speed, the California Verbal Learning Test-Second Edition (CVLT-II) for verbal learning and memory, and the Brief Visuospatial Memory Test-Revised (BVMT-R) for visuospatial learning and memory. Test scores will be recorded separately, with higher scores generally indicating better cognitive performance.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start15 Aug 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies 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
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Saracoglu, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07766213
- Sponsor's protocol ID
- NisaPHD
- Status last verified
- Aug 2026
- First submitted
- 11 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Phenotyping in Multiple Sclerosis Based on IASP Criteria
- ClinicalTrials.gov ID
- NCT07766213
- Acronym / sponsor ID
- NisaPHD
- Conditions
- Multiple Sclerosis, Chronic Pain
- Keywords
- CHRONIC PAIN, NEUROPATHIC PAIN, NOCIPLASTIC PAIN, MULTIPLE SCLEROSIS
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 14 Aug 2026 (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 observational cross-sectional study aims to determine chronic pain phenotypes in individuals with multiple sclerosis (MS) and to investigate the clinical characteristics associated with different pain phenotypes. Participants with MS and chronic pain will undergo a comprehensive clinical assessment to identify nociceptive, neuropathic, nociplastic, and mixed pain phenotypes. The assessment will include clinical history, pain characteristics and distribution, quantitative sensory testing, pain intensity, disease severity, fatigue, health-related quality of life, and pain catastrophizing. The clinical characteristics of participants with different pain phenotypes will subsequently be compared.
Detailed description
Multiple sclerosis (MS) is a chronic, progressive, autoimmune disease of the central nervous system characterized by inflammatory demyelination and axonal damage. Pain is common among individuals with MS and may substantially affect functioning and quality of life. Different pain mechanisms may coexist in individuals with MS; however, the contribution of nociceptive, neuropathic, nociplastic, and mixed pain phenotypes in this population remains insufficiently characterized.
This cross-sectional observational study will include individuals with a definite diagnosis of MS who experience chronic pain. Participants will undergo a comprehensive clinical assessment to determine their predominant pain phenotype. Pain phenotyping will incorporate clinical history, pain characteristics and distribution, hypersensitivity findings, comorbidities, and quantitative sensory testing.
Quantitative sensory testing will include static tactile mechanical detection, thermal perception, static mechanical allodynia, dynamic mechanical allodynia, and vibration perception. Testing will be performed under standardized environmental conditions and initially at the participant's most painful body region.
In addition to pain phenotyping, pain intensity, pain distribution, pain catastrophizing, fatigue, health-related quality of life, and MS disease severity will be evaluated. Clinical characteristics will subsequently be compared among participants with different pain phenotypes to investigate the potential clinical impact of pain mechanisms in individuals with MS.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants meeting the inclusion criteria will be taken for this cross-sectional study. Individuals with MS who apply to Kutahya Health Sciences University Hospital Physiotherapy Department will be screened for eligibility by their clinic physicians and will then be asked to participate in this study.
Key inclusion criteria (5 listed)
- Age 18 years or older
- Definite diagnosis of multiple sclerosis according to the McDonald criteria
- No MS relapse or high-dose steroid treatment within the previous 3 months
- Pain intensity ≥2 on the Numeric Rating Scale in at least one body region for at least 3 months
- Ability to read, understand, and communicate in Turkish
Key exclusion criteria (3 listed)
- Pregnancy
- Severe psychiatric disorder and/or severe cognitive impairment confirmed by a neurologist or neuropsychiatrist
- Presence of a serious pathology or disease that may compromise the assessment process or affect clinical decision-making, including metastasis, cancer, untreated or unhealed fractures, neurological disorders other than multiple sclerosis, or a history of diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain classification methodA current clinical algorithm will be used to determine the predominant type of pain in individuals with MS. The classification to diagnose nociceptive, neuropathic and nociplastic pain will based on a recent method developed by Nijs et al. This method consists of seven steps in total. These steps question the following, respectively: duration of pain, pain distribution, presence of nociceptive pain, presence of neuropathic pain, phenomenon of hypersensitivity, presence of hypersensitization and presence of specific comorbidity. Besides, inter-rater and intra-rater reliability of pain classification algorithm will be determined by two independent researchers. | Diagnostic test | – |
Primary outcome
Quantitative sensory test: static tactile mechanical threshold
Time frame: 10 minutes
Von Frey Monofilaments (2 gr- 26 gr) will be used assessment for the static tactile mechanical detection threshold.
Quantitative sensory test: hot-cold pain threshold
Time frame: 5 minutes
Coins will be used for the hot-cold pain threshold. The cold sensing test will be done with a coin held at room temperature. The hot sensing test will be done in the form of a coin placed in the pocket and applied to the participant after waiting for 30 minutes.
Quantitative sensory test: static mechanical allodynia
Time frame: 5 minutes
A digital algometer device (JTech) will be used for static mechanical allodynia (pressure pain threshold). In the device, the pain sensation will be tested by applying 4 kg of pressure to the participant.
Quantitative sensory test: dynamic mechanical allodynia
Time frame: 5 minutes
A soft brush will be used for dynamic mechanical allodynia. The brush will be gently moved over the skin at a speed of 3-5 cm per second in a fixed direction over the patients primary painful area.
Quantitative sensory test: vibration sense
Time frame: 5 minutes
128 Hz tuning fork will be used in vibration assessment. The device will be applied over the bony prominences in the painful area of the patient.
Margolis Pain Diagram
Time frame: 1 minute
The Margolis Pain Diagram, consists of a dorsal and a ventral drawing body, is used to assess the location and distribution of the pain [20]. Participants will ask to point out the place where they experience pain during the preceding 4 weeks for at least 24 hours.
8 secondary outcomes
Numeric Pain Rating Scale
Time frame: 1 minute
Pain Catastrophizing Scale (PCS)
Time frame: 5 minutes
Modified Fatigue Impact Scale (MFIS)
Time frame: 1 minute
Health-Related Quality of Life
Time frame: 5 minutes
Multiple Sclerosis Disease Severity
Time frame: 5 minutes
Overactive Bladder Questionnaire-V8 (OAB-V8)
Time frame: 5 minutes
Hospital Anxiety and Depression Scale (HADS)
Time frame: 5 minutes
Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
Time frame: 10 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis and Chronic Pain, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
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 3 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: opening soon, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nisa TURUTGEN, Msc. (00902742651300 ext. 1499, nisa.turutgen@ksbu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative sensory test: static tactile mechanical threshold (time frame: 10 minutes). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Aug 2026.