Deciphering Persistent Orofacial Pain - PIFP

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorUniversitätsklinikum Hamburg-Eppendorf

About this trial

Persistent non-dental orofacial pain is common yet poorly characterised, and its pathophysiology remains largely unknown. Two clinically similar entities are distinguished: post-traumatic trigeminal neuropathic pain (PTNP), in which peripheral nerve damage is demonstrable, and persistent idiopathic facial pain (PIFP), in which peripheral findings are typically absent - pointing to an altered central processing of trigeminal nociceptive input. This monocentric study characterises the peripheral and central mechanisms of PIFP by comparing PIFP patients with age- and sex-matched healthy controls using a combination of non-invasive peripheral and central approaches.

The study comprises two work packages. The peripheral work package uses quantitative sensory testing (standardised DFNS protocol) to test the hypothesis that PIFP patients retain an intact peripheral nervous system. The central work package uses functional MRI with standardised trigemino-nociceptive stimulation to characterise brainstem network dynamics, testing the hypothesis that PIFP patients exhibit a central trigeminal processing disturbance at the brainstem level. In PIFP patients, the functional MRI is repeated before and after a local-anaesthetic nerve block in the pain area, additionally distinguishing patients whose pain is completely abolished by the block from those with persistent pain despite it. The overarching aim is to characterise the pathophysiological basis of PIFP and thereby advance the mechanistic understanding of persistent orofacial pain.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy controls: written informed consent.

PIFP cohort: written informed consent, and a diagnosis of PIFP according to the ICHD-3 and ICOP diagnostic criteria.

Disqualifiers

Contraindication to MR scanning

Anxiety disorders, including claustrophobia

Other somatic diseases, including other pain disorders

Other primary headache disorders and medication-overuse headache

Trial population

Patients with PIFP will be recruited from the headache/facial pain outpatient clinic of the University Medical Center Hamburg-Eppendorf

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

60 Participants
are grouped into 2 trial groups
Group A: Patients with persistent idiopathic facial pain (PIFP)
Group B: Age- and sex-matched healthy controls (HC)

Trial outcomes

Primary outcomes

1

Difference in brain functional neuroimaging response to standardized trigemino-nociceptive stimulation between PIFP patients HC

BOLD signal change (contrast estimates, arbitrary units) during standardized trigemino-nociceptive stimulation versus baseline, compared between PIFP patients and HC in a priori defined regions of interest and at whole-brain level.

Time frame
Baseline (MRI session before local anesthesia)
2

Difference in brain activation before versus after the local-anesthetic nerve block, and between complete responders and non-responders

BOLD signal change (contrast estimates, arbitrary units) during standardized trigemino-nociceptive stimulation, compared within participants before versus after the local-anesthetic nerve block, and between participants whose pain is completely abolished by the block and those with persistent pain despite the block

Time frame
Pre-block MRI at baseline and post-block MRI, both on the same day 1

Secondary outcomes

1

Comparison of deep phenotyping and quantitative sensory testing (QST) parameters between the study cohorts (PIFP versus HC).

Standardized DFNS quantitative sensory testing parameters (thermal and mechanical detection and pain thresholds), compared between PIFP patients and HC.

Time frame
Baseline (single assessment before local anesthesia)

Other outcomes

Sponsors and contacts

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