Botox Injections for Patients With Persistent Facial Pain
NCT ID: NCT03462290
Last Updated: 2021-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
31 participants
INTERVENTIONAL
2018-05-01
2021-11-23
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Botulinum toxin
botulinum toxin type A
Botulinum toxin type A, powder for solution, 25 international units (IU), injected towards the sphenopalatine ganglion using MultiGuide
placebo
solution without botulinum toxin A, injected towards the sphenopalatine ganglion using MultiGuide
placebo
botulinum toxin type A
Botulinum toxin type A, powder for solution, 25 international units (IU), injected towards the sphenopalatine ganglion using MultiGuide
placebo
solution without botulinum toxin A, injected towards the sphenopalatine ganglion using MultiGuide
Interventions
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botulinum toxin type A
Botulinum toxin type A, powder for solution, 25 international units (IU), injected towards the sphenopalatine ganglion using MultiGuide
placebo
solution without botulinum toxin A, injected towards the sphenopalatine ganglion using MultiGuide
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
80 Years
ALL
No
Sponsors
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St. Olavs Hospital
OTHER
Norwegian University of Science and Technology
OTHER
Responsible Party
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Principal Investigators
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Jorunn L Helbostad, PhD prof
Role: STUDY_DIRECTOR
Norwegian University of Science and Technology
Locations
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Department of Neuroscience, Faculty of Medicine and Health Science, NTNU
Trondheim, , Norway
Countries
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References
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Jamtoy KA, Thorstensen WM, Stovner LJ, Rosen A, Maarbjerg S, Bratbak D, Simpson MR, Tronvik E. Onabotulinum toxin A block of the sphenopalatine ganglion in patients with persistent idiopathic facial pain: a randomized, triple-blind, placebo-controlled, exploratory, cross-over study. Cephalalgia. 2023 Jul;43(7):3331024231187132. doi: 10.1177/03331024231187132.
Other Identifiers
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2017-002518-30
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
010817-0
Identifier Type: -
Identifier Source: org_study_id