Headache Disorders, Trigeminal Neuralgia
Conditions
Keywords
Nerve block, Sphenopalatine Ganglion Block, Botulinum Toxins, Type A
Brief summary
Trigeminal neuralgia is one of the strongest pains known to humans. Some patients do not have enough effect with the available pharmaceutical treatments and are offered surgery. There are different types of procedures and most of them are complex with a risk for complications. The researchers want to start a pilot study on 10 patients with a new surgical technique using neuronavigation. The target will be a neural structure (sphenopalatine ganglion) which has an important role in facial pain. There have been a few trials trying to block this structure in trigeminal neuralgia, but none using this new approach with botulinum toxin. The researchers technique requires local anesthesia only (awake patient). The researchers believe that this treatment can become a low threshold-treatment for patients who do not have enough effect with pharmacological treatment and a better alternative to other complex surgical approaches. Using this new neuronavigation system the researchers can reach this neural structure with high precision.
Interventions
DRUGBotulinum Toxin Type A
Sponsors
St. Olavs Hospital
Norwegian University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Informed and written consent * Trigeminal neuralgia defined in International Classification of Headache Disorders (ICHD)-3 criteria * Unsatisfactory effect of pharmacological treatment
Exclusion criteria
* Microvascular decompression is seen as a better alternative * Heart or lung disease * Any kind of systematic or local disease or illness that may significantly increase the risk of complications for the procedure related to injection * Psychiatric illness that hinders participation in the study * Known pregnancy or breast feeding * Inadequate use of contraceptives * Overuse or abuse of opioids * Abuse of medications, narcotics or alcohol * Anomalies which hinder or impede the used method of injection * Allergy or any other hypersensitivity reactions against marcain, lidocaine, xylocain or adrenalin, botulinum toxin type A, Botox or any of it's constituents or any other related medication * Treatment with medication that can interact with botulinum toxin type A
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of adverse events | for the follow-up period of 12 weeks | Number of adverse events. Registration of any adverse events categorized by probable relationship to drug or the procedure. Data obtained from the headache diaries as well as open questions during consultations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of attacks with trigeminal neuralgia | 12 weeks | — |
| Intensity of the attacks | 12 weeks | expressed as score on Visual analogue scale (VAS) for pain |
| Number of attacks with trigeminal neuralgia per 4 weeks per patient | 12 weeks | — |
| Number of doses of analgesics per 4 weeks per patient | 12 weeks | — |
Countries
Norway
Outcome results
None listed