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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-002518-30 | EudraCT Number |
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| Name | Class |
|---|---|
| St. Olavs Hospital | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Botulinum toxin | Experimental |
| |
| placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| botulinum toxin type A | Drug | Botulinum toxin type A, powder for solution, 25 international units (IU), injected towards the sphenopalatine ganglion using MultiGuide |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with pain intensity rating 1-3 (mild pain) | 8 weeks | |
| 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. |
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Inclusion Criteria:
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jorunn L Helbostad, PhD prof | Norwegian University of Science and Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neuroscience, Faculty of Medicine and Health Science, NTNU | Trondheim | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37435807 | Derived | 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. |
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| ID | Term |
|---|---|
| D005157 | Facial Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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a randomized, double-blind, cross-over, placebo-controlled pilot study
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|
| placebo | Drug | solution without botulinum toxin A, injected towards the sphenopalatine ganglion using MultiGuide |
|
| 8 weeks |
| Physical functioning assessed by Norwegian Pain association - minimal questionnaire (NOSF-MISS) | 8 weeks |
| Quality of life according to Questionnaire for quality of life, Patient Global Impression of Change (PGIC) | 8 weeks |
| Number of days without persistent idiopathic facial pain | 8 weeks |
| number of doses of analgesics per 4 weeks | 8 weeks |
| Sick leave due to persistent idiopathic facial pain | 8 weeks |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |