Chronic Pain, Multiple Sclerosis
Conditions
Keywords
CHRONIC PAIN, NEUROPATHIC PAIN, NOCIPLASTIC PAIN, MULTIPLE SCLEROSIS
Brief 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. 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.
Interventions
DIAGNOSTIC_TESTPain classification method
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.
Sponsors
Kutahya Health Sciences University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative sensory test: static tactile mechanical threshold | 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 | 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 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Pain Rating Scale | 1 minute | 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. |
| Pain Catastrophizing Scale (PCS) | 5 minutes | 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. |
| Modified Fatigue Impact Scale (MFIS) | 1 minute | 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. |
| Health-Related Quality of Life | 5 minutes | 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. |
| Multiple Sclerosis Disease Severity | 5 minutes | 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. |
| Overactive Bladder Questionnaire-V8 (OAB-V8) | 5 minutes | 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. |
| Hospital Anxiety and Depression Scale (HADS) | 5 minutes | 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. |
| Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) | 10 minutes | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTNisa TURUTGEN, Msc.
Outcome results
None listed