Presence of Signs of Central Sensitization in Episodic and Chronic Migraine

NCT05162664 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-11-18

No results posted yet for this study

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

Interventions

OTHER

Pressure pain thresholds

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.

OTHER

Thermal detection and pain thresholds

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).

OTHER

Temporal summation

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.

OTHER

Conditioned pain modulation

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.

Sponsors & Collaborators

  • University Ghent

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-15
Primary Completion
2022-08-01
Completion
2022-10-01

Countries

  • Belgium

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05162664 on ClinicalTrials.gov