An observational study in Multiple Sclerosis and Chronic Pain, sponsored by Kutahya Health Sciences University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Kutahya Health Sciences University · Observational
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.
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.
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's planned enrollment of 60 is below the median of 100 across 970 observational studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Kutahya Health Sciences University is the lead sponsor of 219 studies on the registry; 50 are open to participants now.
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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.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 minute
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 10 minutes
Plan to share: No
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Started Aug 2026 (actual). Primary completion is estimated for Jun 2027, 10 months after the start.
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