CTIS2023-507259-31-00进行中（未招募）1 期
The effect of perineural botox on chronic cutaneous neuropathic pain
Aarhus Universitetshospital0 个研究点目标入组 50 人开始时间: 2023年8月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Age = 18 years, In one or more painful and neuro-anatomically relevant area is at least one of the following criteria present when compared to the contralateral side: (1) Hypoesthesia/anesthesia for touch (brush); Hypoesthesia/anesthesia for moderate cold (alcohol swab); (3) Hypoesthesia/anesthesia for moderate heat (thermo roller); (4) Hypoesthesia/anesthesia for pinprick (Neuropen); (5) Allodynia for touch (brush); (6) Allodynia for moderate cold (alcohol swab); (7) Allpdynia for moderate heat (Thermo roller); (8) Hyperalgesia for pinprick (Neuropen), Diagnostic ultrasound guided nerve block performed at the Nerve Injury Clinic at Aarhus University Hospital within the last 28 days before inclusion, where injection of local anesthetic around the neuropathic nerve(s) resulted in a pain reduction to NRS score 3 or below at the same provocation which previously resulted in maximal pain, American Society of Anesthesiologists physical status classification score (ASA) I-III, Suitable candidate for injection of botox (sponsor-investigator's assessment), Informed consent, Able to subjective evaluation of pain, Able to read and understand Danish and to read, understand and sign the informed consent form, Worst pain in rest/activity/at provocation NRS (Numeric rating scale) score = 5 in the primary area(s) of pain for at least 6 months at the time of inclusion, Has tried relevant medical first line treatment for the neuropathic pain where the treatment is currently stable or terminated, The localization of the painful skin area is neuro-anatomically plausible in relation to the suspected nerve damage (sponsor-investigator's assessment)
排除标准
- •Know allergy towards Botulinum A or any substances listed in Produktresumé for ”BOTOX, pulver til injektionsvæske, opløsning 50, 100 og 200 Allergan-enheder”, Breast feeding or pregnancy. All women without verified menopause will be tested for pregnancy (urine HCG) on the day of inclusion. Verified menopause is defined as > 1 year since the last period without any other explanation and age >45 years, Abuse of alcohol or drugs (illegal and prescription drugs) assessed by sponsor-investigator, Participation in other clinical studies which may interfere with the present (sponsor-investigator's assessment), Any ongoing patient case/complaint related to the present cutaneous neuropathic pain, Not able to cooperate, Infection in the area around the site of injection, Significant competing pain which could interfere with the estimation of the treatment effect (sponsor-investigator's assessment), Current diagnosis of progressive neurological disease, Uncontrolled, severe systemic disease, Previous interventional pain treatment (e.g., spinal cord stimulation, cryoneurolysis, botox) without relevant effect for the same persisting, cutaneous neuropathic pain (note that Transcutaneous Electrical Nerve Stimulation, TENS, is not considered interventional), Previous injection of botox for the same persisting, cutaneous neuropathic pain, Number of nerves where the diagnostic nerve block provides pain relief is greater than 3
研究者
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