Botox Injections for Patients With Persistent Facial Pain

Study Overview
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Brief Summary
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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

Official Title
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Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Patients With Persistent Idiopathic Facial Pain: a Randomized, Double-blind, Cross- Over, Placebo-controlled Pilot Study

Conditions
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Facial Pain

Intervention / Treatment
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* Drug: botulinum toxin type A
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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: Poorly localized and may radiate beyond the trigeminal nerve distribution 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: a randomized, double-blind, cross-over, placebo-controlled pilot study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botulinum toxin<br> | Drug: botulinum toxin type A<br>* Botulinum toxin type A, powder for solution, 25 international units (IU), injected towards the sphenopalatine ganglion using MultiGuide<br>* Other names: botox;Drug: placebo<br>* solution without botulinum toxin A, injected towards the sphenopalatine ganglion using MultiGuide<br>|
| Placebo Comparator: placebo<br> | Drug: botulinum toxin type A<br>* Botulinum toxin type A, powder for solution, 25 international units (IU), injected towards the sphenopalatine ganglion using MultiGuide<br>* Other names: botox;Drug: placebo<br>* solution without botulinum toxin A, injected towards the sphenopalatine ganglion using MultiGuide<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline to weeks 5-8 in Numeric Pain Rating Scale (NRS) score for persistent idiopathic facial pain (PIFP) | 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 | 5-8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with pain intensity rating 1-3 (mild pain) |  | 8 weeks | 
| Physical functioning assessed by a Multidimensional Pain Inventory or Brief Pain Inventory interference scale | 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. | 8 weeks | 
| 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 | 
| Number of days without persistent idiopathic facial pain |  | 8 weeks | 
| number of doses of analgesics per 4 weeks |  | 8 weeks | 
| Sick leave due to persistent idiopathic facial pain |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Botulinum Toxins, Type A, Injections, Sphenopalatine Ganglion Block