Pain Control in Episodic and Chronic Migraine

NCT06599905 | Completed

• 1 other identifier: MigOA
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The phenomenon of offset analgesia (OA) refers to a disproportionately large decrease in perceived pain following a slight reduction in the intensity of a noxious heat stimulus. This phenomenon is considered as an indicator of the activation of the endogenous pain modulation system, whose dysfunction is implicated in the pathophysiology of migraine and other chronic pain conditions. This study aims to investigate pain processing mechanisms using the OA paradigm in individuals with episodic migraine (EM) during different phases of the migraine cycle and in those with chronic migraine (CM), with and without medication overuse headache (CMwoMOH and CM-MOH, respectively). A population of healthy subjects matched by sex and age will also be enrolled

Conditions

Migraine

Keywords

migraine; pain; offset analgesia; chronification

Outcome Measures

Primary Outcomes (1)

• Offset analgesia paradigm

  Differences in pain scores on the Visual Analog Scale and during the offset analgesia trial and the constant trials in patients with episodic migraine evaluated in the interictal period compared to patients with chronic migraine (with or without medication overuse) and healthy control subjects matched for sex and age

  Through study completion, an average of 2 years

Secondary Outcomes (2)

• Offset analgesia paradigm in different phase of episodic migraine

  Through study completion, an average of 2 years

• Offset analgesia paradigm in chronic migraine with or without medication overuse headache

  Through study completion, an average of 2 years

Study Arms (3)

Group with episodic migraine (EM)

EXPERIMENTAL

Subjects with episodic migraine (EM) with or without aura according to the International Headache Society (IHS) Classification (3rd edition).

Other: Chronic Migraine (CM)

Group with chronic migraine (EC)

EXPERIMENTAL

Subjects with chronic migraine (CM) with or without Medication Overuse (MO) according to the International Headache Society (IHS) Classification (3rd edition).

Other: Episodic Migraine (EM)

Control group

OTHER

Age- and sex-matched controls.

Other: Episodic Migraine (EM); Other: Chronic Migraine (CM)

Interventions

Episodic Migraine (EM) OTHER

Three stimulus offset trials (OT) and three constant temperature trials (CT) applied to the forehead based on the individual heat pain threshold (HPT).

Control group; Group with chronic migraine (EC)

Chronic Migraine (CM) OTHER

Three stimulus offset trials (OT) and three constant temperature trials (CT) applied to the forehead based on the individual heat pain threshold (HPT).

Control group; Group with episodic migraine (EM)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients affected by episodic or chronic migraine according to the International Headache Society (IHS) Classification (3rd edition), aged 18 to 70 years

You may not qualify if:

• any other headache diagnosis according to the IHS classification
• other acute or chronic pain conditions
• serious internal, psychiatric, or neurological systemic diseases
• pregnancy, breastfeeding, skin pathologies in the tested trigeminal nerve area (V1)
• poor sleep quality the night before testing
• alcohol consumption or intense exercise within 24 hours prior to examination
• women were not assessed during their menstrual cycle.
• Use of migraine prophylactic medication for patients with EM.

Sponsors & Collaborators

• IRCCS National Neurological Institute "C. Mondino" Foundation: lead

Study Sites (1)

Clinical Trial Center

Pavia, 27100, Italy

Location

Related Publications (10)

• Cosentino G, Fierro B, Vigneri S, Talamanca S, Paladino P, Baschi R, Indovino S, Maccora S, Valentino F, Fileccia E, Giglia G, Brighina F. Cyclical changes of cortical excitability and metaplasticity in migraine: evidence from a repetitive transcranial magnetic stimulation study. Pain. 2014 Jun;155(6):1070-1078. doi: 10.1016/j.pain.2014.02.024. Epub 2014 Mar 13.

  PMID: 24631596 BACKGROUND

• Schulte LH, May A. The migraine generator revisited: continuous scanning of the migraine cycle over 30 days and three spontaneous attacks. Brain. 2016 Jul;139(Pt 7):1987-93. doi: 10.1093/brain/aww097. Epub 2016 May 5.

  PMID: 27190019 BACKGROUND

• Tassorelli C, Greco R, Silberstein SD. The endocannabinoid system in migraine: from bench to pharmacy and back. Curr Opin Neurol. 2019 Jun;32(3):405-412. doi: 10.1097/WCO.0000000000000688.

  PMID: 30883435 BACKGROUND

• Szikszay TM, Adamczyk WM, Carvalho GF, May A, Luedtke K. Offset analgesia: somatotopic endogenous pain modulation in migraine. Pain. 2020 Mar;161(3):557-564. doi: 10.1097/j.pain.0000000000001739.

  PMID: 31693545 BACKGROUND

• de Tommaso M, Losito L, Difruscolo O, Sardaro M, Libro G, Guido M, Lamberti P, Livrea P. Capsaicin failed in suppressing cortical processing of CO2 laser pain in migraine patients. Neurosci Lett. 2005 Aug 12-19;384(1-2):150-5. doi: 10.1016/j.neulet.2005.04.086.

  PMID: 15927376 BACKGROUND

• de Tommaso M, Difruscolo O, Sardaro M, Libro G, Pecoraro C, Serpino C, Lamberti P, Livrea P. Effects of remote cutaneous pain on trigeminal laser-evoked potentials in migraine patients. J Headache Pain. 2007 Jun;8(3):167-74. doi: 10.1007/s10194-007-0385-8. Epub 2007 Jun 11.

  PMID: 17563842 BACKGROUND

• Coppola G, Di Clemente L, Fumal A, Magis D, De Pasqua V, Pierelli F, Schoenen J. Inhibition of the nociceptive R2 blink reflex after supraorbital or index finger stimulation is normal in migraine without aura between attacks. Cephalalgia. 2007 Jul;27(7):803-8. doi: 10.1111/j.1468-2982.2007.01323.x.

  PMID: 17598762 BACKGROUND

• Perrotta A, Serrao M, Sandrini G, Burstein R, Sances G, Rossi P, Bartolo M, Pierelli F, Nappi G. Sensitisation of spinal cord pain processing in medication overuse headache involves supraspinal pain control. Cephalalgia. 2010 Mar;30(3):272-84. doi: 10.1111/j.1468-2982.2009.01914.x. Epub 2010 Feb 15.

  PMID: 19614707 BACKGROUND

• Grill JD, Coghill RC. Transient analgesia evoked by noxious stimulus offset. J Neurophysiol. 2002 Apr;87(4):2205-8. doi: 10.1152/jn.00730.2001.

  PMID: 11929939 BACKGROUND

• Ligato D, Petersen KK, Morch CD, Arendt-Nielsen L. Offset analgesia: The role of peripheral and central mechanisms. Eur J Pain. 2018 Jan;22(1):142-149. doi: 10.1002/ejp.1110. Epub 2017 Sep 12.

  PMID: 28898500 BACKGROUND

MeSH Terms

Conditions

Migraine Disorders; Pain

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

Study Officials

• Giuseppe Cosentino, MD

  Translational Neurophysiology - Headache and Neurorehabilitation Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To evaluate differences in the response to offset analgesia (OA) paradigm between episodic and chronic migraine patients and controls

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: September 19, 2024
• Study Start: June 15, 2021
• Primary Completion: January 15, 2024
• Study Completion: April 15, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)