Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06599905
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Pain Control in Episodic and Chronic Migraine
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Endogenous Pain Control Mechanisms Throughout the Migraine Cycle and in Chronic Migraine
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
Migraine is a cyclic disorder marked by varying activity in different brain regions It is generally believed that migraine involves a pronociceptive pain modulation pattern likely due to impaired endogenous pain inhibitory systems However there are few studies in this respect and different experimental approaches have produced mixed results showing both normal and abnormal pain responses in migraine Most research has focused only on episodic migraine EM during headache-free periods leaving the role of pain modulation dysfunction in recurring migraines and the progression to chronic migraine unexplored Conditioned Pain Modulation CPM tests which measure the pain inhibits pain effect are commonly used to assess inhibitory pain modulation Studies comparing CPM responses in migraine sufferers and healthy individuals have yielded inconsistent findings with some showing reduced inhibitory responses in migraineurs while others found no difference Offset Analgesia OA is another method used to study descending pain modulation systems in chronic pain conditions Unlike CPM OA examines temporal filtering of pain when dynamic noxious stimuli are applied and is characterized by a large reduction in pain sensation after a small decrease in a heat stimulus Research indicates that central mechanisms including the activation of descending pain modulatory and reward systems play a significant role in OA Only one study has explored the OA response in episodic migraine patients during headache-free intervals finding no inhibitory pain modulation in the trigeminal area This study aims to 1 assess changes in pain modulation across the migraine cycle in EM patients and 2 determine if different dysfunctional pain modulation patterns are present in chronic migraine both with and without medication-overuse headache CMwoMOH and CM-MOH
Subjects and methods The investigators will enroll 30 subjects with EM 30 patients with CM with and without MOH and 30 healthy control subjects Patients with EM during the preictal ictal and postictal phases will be also enrolled All participants underwent an experimental paradigm consisting of three stimulus offset trials OT and three constant temperature trials CT applied to the forehead based on the individual heat pain threshold HPT All tests will be carried out by using a Q-sense CPM device Medoc and computerized visual analogue scale CoVAS
Experimental paradigms All subjects will be assessed in a single experimental session After obtaining written consent participants will complete various questionnaires The Heat Pain Threshold HPT will be then measured on the forehead 1st branch of the trigeminal nerve V1 followed by three constant trials CT and three offset-analgesia trials OT in the same area The following questionnaires will be administered 12-item Allodynia Symptom Checklist ASC-12 Migraine Disability Assessment MIDAS and Hospital Anxiety and Depression Scale HADS
Subjects and methods The investigators will enroll 30 subjects with EM 30 patients with CM with and without MOH and 30 healthy control subjects Patients with EM during the preictal ictal and postictal phases will be also enrolled All participants underwent an experimental paradigm consisting of three stimulus offset trials OT and three constant temperature trials CT applied to the forehead based on the individual heat pain threshold HPT All tests will be carried out by using a Q-sense CPM device Medoc and computerized visual analogue scale CoVAS
Experimental paradigms All subjects will be assessed in a single experimental session After obtaining written consent participants will complete various questionnaires The Heat Pain Threshold HPT will be then measured on the forehead 1st branch of the trigeminal nerve V1 followed by three constant trials CT and three offset-analgesia trials OT in the same area The following questionnaires will be administered 12-item Allodynia Symptom Checklist ASC-12 Migraine Disability Assessment MIDAS and Hospital Anxiety and Depression Scale HADS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None