Trigeminal Neuropathy, Traumatic

50 U BTX-A (BOTOX®, Allergan) powder diluted in 2 mL saline solution (0.9% NaCl) administrated at visit 2 by intra oral injection

BOTOX®, Allergan

2 mL saline solution (0.9% NaCl) administrated at visit 2 by intra oral injection

Placebo

Groupe Hospitalier Pitié-Salpêtrière

Botulinum Toxin Injections for Oral Neuropathic Pain

Use of Botulinum Toxin (BTX) for the Treatment of Peripheral Painful Traumatic Trigeminal Neuropathy (PPTTN)

Self-reported average pain intensity from each morning's record in a diary concerning the last 24 hours during one week, before and one month after injection

Pain recorded each morning in a diary (diary 2) concerning the last 24 hours, using the 11-point numerical scale (NS; 0 = no pain; 10 = maximal pain imaginable) of the Brief Pain Inventory (BPI) at 1 month, 3 months and 6 months. The least, average, and maximum pain intensity during the 7 days will be collected and compared to baseline.

Items of the neuropathic pain symptom inventory (NPSI) will be recorded during the last 24 hours on 11-points (0-10 points) numerical scales.

Visual Analogic Scale (VAS) (from 0 mm [no pain relief] to 100 mm [maximal pain relief]).

The Clinical Global Impression - Improvement scale (CGI-I) (a 7-point scale rating from very much improved to very much worse) will be used .

The areas of main pain and referred pain will be reported directly from the patient to a soft foil, then digitized for measurement on Image J software.

According to the conclusions of the European task force committee for intraoral quantitative sensory testing (QST), the QST is defined by :
Brush-induced allodynia will be evaluated stroking the skin with a standardized brush and will be considered as present if evoking a clear sensation of pain. The intensity of allodynia will be recorded on a 100 mm visual analog scale. Area of Brush-induced allodynia will be traced on a transparent plastic foil, and then digitized for measurement on Image J software.
Mechanical sensations (detection thresholds to non-painful stimuli) and pain thresholds will be measured with calibrated von Frey hairs (0.06-300gm) (Bioseb, France) (or electronic von Frey, Bioseb France).
Thermal sensations and pain thresholds (in °C) will be assessed with a thermoalgometer (TSA II; Medoc, Israel) with an intraoral thermode by the method of limits, with baseline temperatures adjusted to the patient's skin temperature .

Emotional state using the Hospital Anxiety and Depression Scale (HADS) including 14 items scored as anxiety and depression scores (each on 21)

Emotional state using items of the Brief Pain Inventory (BPI).

Interference with oral function will be measured with the Brief Pain Inventory (BPI) (with the exclusion of the item "ability to walk" changed for "ability to chew" judged more relevant here) rated from 0 (does not interfere) to 10 (complete interference).

Quality of life will be assessed with specific questionnaires Geriatric Oral Health Assessment Index (GOHAI)

Quality of life will be assessed with specific Oral Health Impact Profile (OHIP)

Safety of BTX-A, particularly for potential systemic adverse effects, will be assessed throughout the study. Adverse events will be declared in the case report form (CRF).

Pain related to injections will be rated as mild, moderate, or severe.

measurement of the time course of the pain throughout the day with a diary (diary 1) in which the patient reports his/her pain every hour on a numeric scale (0-10) during 7 days.

hyperkinesis/peavalu

Botulinum Toxin Injections for Oral Neuropathic Pain

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