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Botox Injections for Patients With Persistent Facial Pain

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ClinicalTrials.gov Identifier: NCT03462290
Recruitment Status : Recruiting
First Posted : March 12, 2018
Last Update Posted : October 10, 2019
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

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

Condition or disease Intervention/treatment Phase
Facial Pain Drug: botulinum toxin type A Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: a randomized, double-blind, cross-over, placebo-controlled pilot study
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Botox

Arm Intervention/treatment
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 Name: botox

Drug: placebo
solution without botulinum toxin A, injected towards the sphenopalatine ganglion using MultiGuide

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 Name: botox

Drug: placebo
solution without botulinum toxin A, injected towards the sphenopalatine ganglion using MultiGuide




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Percentage of patients with pain intensity rating 1-3 (mild pain) [ Time Frame: 8 weeks ]
  2. 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.

  3. Physical functioning assessed by Norwegian Pain association - minimal questionnaire (NOSF-MISS) [ Time Frame: 8 weeks ]
  4. Quality of life according to Questionnaire for quality of life, Patient Global Impression of Change (PGIC) [ Time Frame: 8 weeks ]
  5. Number of days without persistent idiopathic facial pain [ Time Frame: 8 weeks ]
  6. number of doses of analgesics per 4 weeks [ Time Frame: 8 weeks ]
  7. Sick leave due to persistent idiopathic facial pain [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03462290


Contacts
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Contact: Kent Are Jamtøy, MD 0047 72575888 kent.a.jamtoy@ntnu.no

Locations
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Norway
Department of Neuroscience, Faculty of Medicine and Health Science, NTNU Recruiting
Trondheim, Norway
Contact: Kent Are Jamtøy, MD    0047 72575888    kent.a.jamtoy@ntnu.no   
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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Study Director: Jorunn L Helbostad, PhD prof Norwegian University of Science and Technology

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03462290     History of Changes
Other Study ID Numbers: 010817-0
2017-002518-30 ( EudraCT Number )
First Posted: March 12, 2018    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Norwegian University of Science and Technology:
Botulinum Toxins, Type A
Injections
Sphenopalatine Ganglion Block
Additional relevant MeSH terms:
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Facies
Facial Pain
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
abobotulinumtoxinA
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents