Pain Phenotypes in Individuals With Multiple Sclerosis
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKutahya Health Sciences University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 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.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Pain classification method
Diagnostic testA 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.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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 minutes2
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 minutes3
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 minutes4
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 minutesSecondary outcomes
1
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 minute2
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 minutes3
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 minute4
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 minutesSponsors and contacts
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Source ClinicalTrials.gov
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