NCT04911569Unknown不适用
The Effect of Ultrasound-guided Cryoneurolysis on Persistent Cutaneous Neuropathic Pain After Surgery and Trauma
Aarhus University Hospital2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年6月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Success of cryoneurolysis
研究概览
简要总结
Feasibility study with 25 patients investigating the effect of cryoneurolysis on persistent cutaneous neuropathic pain after surgery and trauma. All patients receive active treatment (cryoneurolysis). The study design is unblinded, non-randomized, non-controlled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 17 years
- •ASA (American Society of Anesthesiologists) physical status classification system I-III
- •Informed consent
- •Capable of subjective evaluation of pain
- •Capable of reading and understanding Danish and informed written consent
- •Average pain intensity >49/100 on VAS in the primary focal pain area for a minimum of 6 months at the time of inclusion
- •Relevant injury (surgery or trauma) of peripheral nerves
- •Plausible cutaneous location of pain
- •In the area of pain, at least one of the following (1-8): (1) Hypo/anesthesia for touch/brush (2) Hypo/anesthesia for cold (3) Hypo/anesthesia for warmth (4) Hypo/anesthesia for pinprick (5) Allodynia for touch/brush (6) Allodynia for cold (7) Allodynia for warmth (8) Hyperalgesia for pinprick
- •Neuropathic pain score (Douleur Neuropathique en 4 Questions, DN-4) >3/10
- •Definitive diagnosis of neuropathic pain (Finnerup et al 2016)
排除标准
- •Inability to cooperate
- •Inability to understand Danish
- •Allergy to local anesthetic
- •Infection in the area of cryo probe insertion
- •Significant competitive chronic pain
- •Progressive neurologic disease
- •Increased risk at needle insertion and cold exposure (e.g. Raynaud, coagulopathies)
- •Uncontrolled severe systemic disease
- •Implanted electronic devices unless approved by the relevant medical specialist
- •Previous cryoneurolysis with no relevant effect for the same neuropathic pain
- •Previous interventional pain therapy (e.g. spinal cord stimulation) with no relevant effect for the same neuropathic pain
- •Expected duration of life < 2 years
- •Pregnancy
- •Abuse of alcohol, narcotics or medicine
- •Current psychiatric disease
- •Inclusion in other clinical trials
- •Ongoing patient complaint
- •Body mass index < 18.5 or > 34.9 kg/m2
- •Change of pain therapy within the last 28 days prior to inclusion
结局指标
主要结局
Success of cryoneurolysis
时间窗: 1 hour after cryoneurolysis
Frequency of patients with \> 50% reduction of neuropathic pain
次要结局
- Change of neuropathic pain score DN-4(1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure)
- Frequency of NRS score < 4(1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure)
- Pain score(1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryoneurolysis procedure)
- Hyperalgesia for pinprick(1 hour after cryo procedure compared to baseline)
- Duration of freedom of pain (number of days after the cryoneurolysis procedure)(Maximum follow-up until 12 months after cryoneurolysis procedure)
- Patient satisfaction at completion of cryo procedure(From skin insertion of cryo probe to withdrawal of cryo probe)
- Axonal loss estimated before cryoneurolysis(Maximum one year prior to the cryoneurolysis procedure)
- Allodynia for brush(1 hour after cryo procedure compared to baseline)
- Change in muscle strength of relevant muscle groups(1 hour after cryoneurolysis compared to baseline)
- Pain related medication(2 weeks and 1,2,3,4,5 and 6 months after cryo procedure)
- PGIC(2 weeks and 1,2,3,4,5 and 6 months after cryo procedure)
- Procedure time for cryoneurolysis(From skin insertion of cryo probe to withdrawal of cryo probe)
- Adverse events(1 hour, 2 weeks and 1,2,3,4,5 and 6 months after cryo procedure)
研究者
研究点 (2)
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