NCT03462290已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Changes from baseline to weeks 5-8 in Numeric Pain Rating Scale (NRS) score for persistent idiopathic facial pain (PIFP)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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:
- •Poorly localized and may radiate beyond the trigeminal nerve distribution
- •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.
排除标准
- •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.
研究组 & 干预措施
Botulinum toxin
Experimental
干预措施: botulinum toxin type A (Drug)
Botulinum toxin
Experimental
干预措施: placebo (Drug)
placebo
Placebo Comparator
干预措施: botulinum toxin type A (Drug)
placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Changes from baseline to weeks 5-8 in Numeric Pain Rating Scale (NRS) score for persistent idiopathic facial pain (PIFP)
时间窗: 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
次要结局
- Physical functioning assessed by Norwegian Pain association - minimal questionnaire (NOSF-MISS)(8 weeks)
- Percentage of patients with pain intensity rating 1-3 (mild pain)(8 weeks)
- Quality of life according to Questionnaire for quality of life, Patient Global Impression of Change (PGIC)(8 weeks)
- Physical functioning assessed by a Multidimensional Pain Inventory or Brief Pain Inventory interference scale(8 weeks)
- Number of days without persistent idiopathic facial pain(8 weeks)
- Sick leave due to persistent idiopathic facial pain(8 weeks)
- number of doses of analgesics per 4 weeks(8 weeks)
研究者
研究点 (1)
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