Botox Injections for Patients With Persistent Facial Pain

Facial Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03462290
• Other study ID #: 010817-0
• Secondary ID: 2017-002518-30
• Status: Completed
• Phase: Phase 2
• Start date: May 1, 2018
• Est. completion date: November 23, 2021

Study information

• Verified date: December 2021
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 23, 2021
• Est. primary completion date: November 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Facial Pain
• Facies

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Norway	Department of Neuroscience, Faculty of Medicine and Health Science, NTNU	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Percentage of patients with pain intensity rating 1-3 (mild pain)		8 weeks
Secondary	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
Secondary	Physical functioning assessed by Norwegian Pain association - minimal questionnaire (NOSF-MISS)		8 weeks
Secondary	Quality of life according to Questionnaire for quality of life, Patient Global Impression of Change (PGIC)		8 weeks
Secondary	Number of days without persistent idiopathic facial pain		8 weeks
Secondary	number of doses of analgesics per 4 weeks		8 weeks
Secondary	Sick leave due to persistent idiopathic facial pain		8 weeks