Pain Phenotypes in Individuals With Multiple Sclerosis

NCT07766213 | Not Yet Recruiting

• 1 other identifier: NisaPHD
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Chronic Pain

Keywords

CHRONIC PAIN; NEUROPATHIC PAIN; NOCIPLASTIC PAIN; MULTIPLE SCLEROSIS

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  1 minute

Secondary Outcomes (8)

• Numeric Pain Rating Scale

  1 minute

• Pain Catastrophizing Scale (PCS)

  5 minutes

• Modified Fatigue Impact Scale (MFIS)

  1 minute

• Health-Related Quality of Life

  5 minutes

• Multiple Sclerosis Disease Severity

  5 minutes

Interventions

Pain classification method DIAGNOSTIC_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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kutahya Health Sciences University: lead

Study Sites (1)

Kutahya Health Sciences University Physical Medicine and Rehabilitation Department

Kütahya, Turkiye, 43100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Multiple Sclerosis; Chronic Pain; Neuralgia; Nociplastic Pain

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases

Central Study Contacts

Nisa TURUTGEN, Msc.

CONTACT

00902742651300; nisa.turutgen@ksbu.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: August 11, 2026
• First Posted: August 14, 2026
• Study Start (Estimated): August 15, 2026
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): September 15, 2027
• Last Updated: August 14, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)