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Botox Injections for Patients With Persistent Facial Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 26, 2018
First Posted Date  ICMJE March 12, 2018
Last Update Posted Date October 10, 2019
Actual Study Start Date  ICMJE May 1, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03462290 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 5, 2018)
  • Percentage of patients with pain intensity rating 1-3 (mild pain) [ Time Frame: 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.
  • Physical functioning assessed by Norwegian Pain association - minimal questionnaire (NOSF-MISS) [ Time Frame: 8 weeks ]
  • Quality of life according to Questionnaire for quality of life, Patient Global Impression of Change (PGIC) [ Time Frame: 8 weeks ]
  • Number of days without persistent idiopathic facial pain [ Time Frame: 8 weeks ]
  • number of doses of analgesics per 4 weeks [ Time Frame: 8 weeks ]
  • Sick leave due to persistent idiopathic facial pain [ Time Frame: 8 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Botox Injections for Patients With Persistent Facial Pain
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE Facial Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: Botulinum toxin
    Interventions:
    • Drug: botulinum toxin type A
    • Drug: placebo
  • Placebo Comparator: placebo
    Interventions:
    • Drug: botulinum toxin type A
    • Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 5, 2018)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kent Are Jamtøy, MD 0047 72575888 kent.a.jamtoy@ntnu.no
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03462290
Other Study ID Numbers  ICMJE 010817-0
2017-002518-30 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE St. Olavs Hospital
Investigators  ICMJE
Study Director: Jorunn L Helbostad, PhD prof Norwegian University of Science and Technology
PRS Account Norwegian University of Science and Technology
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP