Facial Pain
Conditions
Keywords
Botulinum Toxins, Type A, Injections, Sphenopalatine Ganglion Block
Brief summary
The main objective of this study is to investigate efficacy and safety of injecting botulinum toxin towards the sphenopalatine ganglion using MultiGuide in patients with persistent idiopathic facial pain
Interventions
DRUGbotulinum toxin type A
Botulinum toxin type A, powder for solution, 25 international units (IU), injected towards the sphenopalatine ganglion using MultiGuide
DRUGplacebo
solution without botulinum toxin A, injected towards the sphenopalatine ganglion using MultiGuide
Sponsors
St. Olavs Hospital
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
a randomized, double-blind, cross-over, placebo-controlled pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Persistent Idiopathic Facial Pain fulfilling diagnostic criteria as classified in The International Classification of Headache Disorders, 3rd edition (ICHD-3 beta version) as modified by the authors of this trial. See below. * Unsatisfactory effect of available treatment methods as evaluated by a neurologist, ENT specialist or maxillofacial surgeon. The patient should have failed treatment with both anticonvulsant as carbamazepine (Tegretol, Carbatrol) and antidepressant as tricyclic antidepressants * Average Pain intensity ≥4 (0-10) in Numeric Pain Rating Scale (NRS) on the affected side during the 4-week baseline period * Written informed consent from the patient Modified diagnostic criteria for PIFP according to The International Classification of Headache Disorders, 3rd edition (ICHD-3 beta version): A. Facial and/or oral pain fulfilling criteria B and C. B. Recurring daily for \>2 hr per day for \>3 months C. Pain has both of the following characteristics: 1. Poorly localized and may radiate beyond the trigeminal nerve distribution 2. Dull, aching or nagging quality D. Clinical neurological examination is normal, however patient may denote paresthesia E. A dental cause has been excluded by appropriate investigations; signs of structural pathology or other specific causes of pain are not identified. Minor operation and injury (insignificant trauma e.g. tooth extraction) to the face, maxilla, teeth and gums without a direct causal relationship with the pain regarding both time and site is accepted. F. Not better accounted for by another ICHD-3 diagnosis.
Exclusion criteria
* Bilateral symmetrically affected * Neurological disorders or other related systemic diseases that can explain the pain * MRI/CT examination confirming intracranial pathology. * Systemic or local disease or condition that can give a significantly increased risk of complications to the particular procedure * Not competent to asses informed consent based on neurological assessment * Psychiatric disorder that prevents the completion of the study * Pregnancy * Inappropriate use of contraception * Breastfeeding * Abuse or unauthorized use of medication, drugs or alcohol * Allergy or other hypersensitivity reactions to marcaine, lidocaine, xylocaine, or adrenaline, possibly similar related drugs * Anatomical factors that prevent or impede the injection * Known hypersensitivity to botulinum toxin type A or to any of the excipients * Treatment with drugs that can interact with botulinum toxin type A: aminoglycoside antibiotics, spectinomycin, neuromuscular blockers, both depolarizing (succinylcholine) and non-depolarizing (tubocurarine derivatives), lincosamides, polymyxins, quinidine, magnesium sulfate, anticholinesterases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline to weeks 5-8 in Numeric Pain Rating Scale (NRS) score for persistent idiopathic facial pain (PIFP) | 5-8 weeks | NRS score for persistent idiopathic facial pain (PIFP) as registered in the pain diary in the active group versus the placebo group. Responders are defined as those with at least 30% reduction in NRS for PIFP in weeks 5- 8 compared to baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical functioning assessed by a Multidimensional Pain Inventory or Brief Pain Inventory interference scale | 8 weeks | the total range of the scale is 10, ranging from 0-10 where 0 is no pain and 10 is worst pain imaginable. No subscale. The higher values the worse outcome. |
| Physical functioning assessed by Norwegian Pain association - minimal questionnaire (NOSF-MISS) | 8 weeks | — |
| Quality of life according to Questionnaire for quality of life, Patient Global Impression of Change (PGIC) | 8 weeks | — |
| Percentage of patients with pain intensity rating 1-3 (mild pain) | 8 weeks | — |
| number of doses of analgesics per 4 weeks | 8 weeks | — |
| Sick leave due to persistent idiopathic facial pain | 8 weeks | — |
| Number of days without persistent idiopathic facial pain | 8 weeks | — |
Countries
Norway
Outcome results
None listed