Presence of Signs of Central Sensitization in Episodic and Chronic Migraine

NCT05162664 | Completed

• 1 other identifier: BC-08688
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Nowadays migraine is conceptualized as a continuum, with at the one hand episodic migraine (EM) and at the other hand chronic migraine (CM) (1). The general aim of the study is to determine where exactly in this continuum central sensitization (CS) appears. Recent studies support the presence of CS in migraine patients (2,3), but controversial evidence exists about where in the continuum exactly CS appears. Some studies determined no differences in sings of CS between EM and CM (4,5), whether other research indicate a clear difference between EM and CM (6-8). However a significant difference in CS parameters could be determined between a patient group (EM or CM) and a healthy control group (3,4,8). In addition, CS appears to be present during the migraine attack (2). In this research, the presence of signs of CS will be determined in between headache phases. The primary outcome measure is identification of CS by PPT, QST, TS, CPM and CSI. Secondary outcome measures are the outcome of the MIDAS, HADS and EUROLIGHT.

Conditions

Central Sensitisation; Migraine

Keywords

Migraine; Headache; PPT; CPM; Pain

Outcome Measures

Primary Outcomes (2)

• Extend of central sensitization by quantitative sensory testing (QST) in °C.

  The primary outcome will include heat detection treshold and heat pain treshold.

  at baseline

• Extend of Central sensitization by central sensitization inventory (CSI) as a scale

  The primary outcome will include the score of each participant on the CSI questionnaire.

  at baseline

Secondary Outcomes (2)

• Extend of Disability measured by the MIDAS questionnaire.

  at baseline

• Extend of Anxiety and depression measured by the HADS questionnaire.

  at baseline

Study Arms (2)

Healthy controls

OTHER

Healthy controls

Other: Pressure pain thresholds; Other: Thermal detection and pain thresholds; Other: Temporal summation; Other: Conditioned pain modulation

Patients with migraine

OTHER

Other: Pressure pain thresholds; Other: Thermal detection and pain thresholds; Other: Temporal summation; Other: Conditioned pain modulation

Interventions

Pressure pain thresholds OTHER

PPT will be performed firstly at the anterior tibial muscle halfway between the most superior attachment to the tibia and its tendon in the upper one third of the muscle belly (13) and secondly at the middle of the temporalis muscle (12), using a digital algometer (Wagner FPX 50) with a 1 cm2 rubber tip. The pressure algometer will apply a perpendicular increasing pressure (1kg/s) at the different test locations until the participant reports the first feeling of pain. The PPT of 4 series of ascending stimulus intensities, with an inter-stimulus interval (ISI) of 20sec between the different stimuli and an ISI of 60sec between the 2 locations, will be measured. The first stimulus is a familiarization stimulus. Afterwards the mean of the 3 subsequent stimuli will be calculated.

Healthy controls; Patients with migraine

Thermal detection and pain thresholds OTHER

The thermal tests will be performed unilateral at tibial anterior, thenar and the forehead, using a TSA-2 (Neuro Sensory Analyzer, MEDOC). At first cold and heat detection thresholds will be measured. The patient will be asked to indicate when they feel a change in temperature. Afterwards the patient will be asked to indicate when the stimulus becomes painful to determine the cold and heat pain thresholds. The thresholds of 4 series of stimuli will be measured. The first stimulus is a familiarization stimulus. Afterwards the mean of the 3 subsequent stimuli will be calculated for every location. The subject will push a button when the thresholds are reached. The baseline temperature will be 32°C and the stimuli will increase with 1°C/s (14).

Healthy controls; Patients with migraine

Temporal summation OTHER

The temporal summation will be assessed at the thenar eminence (19,20) using a ramp and hold protocol with the TSA-2 (Neuro Sensory Analyzer, MEDOC). Heat stimuli will be applied for a duration of 15sec. The stimulus temperature will increase from a baseline temperature of 35°C for 9sec at a sensitivity-adjusted rate of about 1,5°C/s until the HTP 5/10 of the thenar is reached. Afterwards the temperature will remain steady for the next 6 seconds. The maximal pain rating should be 50 ± 10 NRS. Subjects rate the pain intensity at the end of the ramp (9sec) and at the end of the hold procedure (15sec) using the NRS. Afterwards the ramp and hold aftersensations are measured. The subjects have to rate the pain intensity every 5sec for 30sec after the termination of the heat stimulus.

Healthy controls; Patients with migraine

Conditioned pain modulation OTHER

CPM will be assessed by comparing heat pain thresholds and pressure pain thresholds before and after giving a conditioning stimulus at a pain free distant zone by using a second thermode of the TSA-2 (17). The conditioning stimulus (HPT 4/10 (18) at the TA) will be applied for 120 seconds. The first test stimulus will be applied at the forehead 30 seconds after the start of the conditioning stimulus (17). The HPT will be measured twice with an ISI of 20 seconds. Immediately after the end of the application of the conditioning stimulus (120 seconds), the HPT at the forehead will be measured again twice, with an ISI of 20 seconds. Afterwards, there will be 10 minutes of rest to avoid bias.

Healthy controls; Patients with migraine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of migraine headache based on the criteria of ICDH-3 and verified by a medical doctor,
• not being pregnant or have given birth in the preceding year,
• adults between the age of 18 years and 65 years.

You may not qualify if:

• any other diagnosis of headache or mixed form,
• any structural neurological syndrome, 3) any neurological brain event in the past,
• \) surgery at the head, neck or shoulder the last 3 years.

Sponsors & Collaborators

• University Ghent: lead

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

Location

MeSH Terms

Conditions

Migraine Disorders; Headache; Pain

Interventions

Pain Threshold; Postsynaptic Potential Summation

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pain; Sensation; Nervous System Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Synaptic Transmission; Signal Transduction; Biochemical Phenomena; Chemical Phenomena; Synaptic Potentials; Membrane Potentials; Cell Physiological Phenomena; Electrophysiological Phenomena; Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In total, three investigators are involved. One is in charge for the screening process, and is not blinded for the status of the participants. The second investigator, i.e. the outcome assessor, is blinded for the status of the participants, and performs the clinical assessments (NOT the questionnaires). A third senior researcher is supervising the process.
• Purpose: BASIC SCIENCE
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cross-sectional study, in which patients with migraine are gender- and age matched to healthy controls, and undergo a pain protocol.

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: December 17, 2021
• Study Start: October 15, 2021
• Primary Completion: August 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)