Botox Injections for Patients With Persistent Facial Pain

December 16, 2021 updated by: Norwegian University of Science and Technology

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

31

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • Department of Neuroscience, Faculty of Medicine and Health Science, NTNU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: botulinum toxin type A
Botulinum toxin type A, powder for solution, 25 international units (IU), injected towards the sphenopalatine ganglion using MultiGuide
Other Names:
  • botox
Drug: placebo
solution without botulinum toxin A, injected towards the sphenopalatine ganglion using MultiGuide
Experimental: Botulinum toxin
Drug: botulinum toxin type A
Botulinum toxin type A, powder for solution, 25 international units (IU), injected towards the sphenopalatine ganglion using MultiGuide
Other Names:
  • botox
Drug: placebo
solution without botulinum toxin A, injected towards the sphenopalatine ganglion using MultiGuide

What is the study measuring?

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)
Time Frame: 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
5-8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of patients with pain intensity rating 1-3 (mild pain)
Time Frame: 8 weeks
8 weeks
Physical functioning assessed by a Multidimensional Pain Inventory or Brief Pain Inventory interference scale
Time Frame: 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.
8 weeks
Physical functioning assessed by Norwegian Pain association - minimal questionnaire (NOSF-MISS)
Time Frame: 8 weeks
8 weeks
Quality of life according to Questionnaire for quality of life, Patient Global Impression of Change (PGIC)
Time Frame: 8 weeks
8 weeks
Number of days without persistent idiopathic facial pain
Time Frame: 8 weeks
8 weeks
number of doses of analgesics per 4 weeks
Time Frame: 8 weeks
8 weeks
Sick leave due to persistent idiopathic facial pain
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

Investigators

  • Study Director: Jorunn L Helbostad, phd prof, Norwegian University of Science and Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2018

Primary Completion (Actual)

November 23, 2021

Study Completion (Actual)

November 23, 2021

Study Registration Dates

First Submitted

February 26, 2018

First Submitted That Met QC Criteria

March 5, 2018

First Posted (Actual)

March 12, 2018

Study Record Updates

Last Update Posted (Actual)

December 17, 2021

Last Update Submitted That Met QC Criteria

December 16, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 010817-0
  • 2017-002518-30 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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