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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
31
Botulinum toxin type A, powder for solution, 25 international units (IU), injected towards the sphenopalatine ganglion using MultiGuide
solution without botulinum toxin A, injected towards the sphenopalatine ganglion using MultiGuide
Department of Neuroscience, Faculty of Medicine and Health Science, NTNU
Trondheim, Norway
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
Time frame: 5-8 weeks
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
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.
Time frame: 8 weeks
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.