Capsaicin 8% patch Qutenza treatment in non-freezing cold injury (NFCI): a clinical trial of repeated patch applications for pain relief and nerve regeneration

Imperial College London0 个研究点目标入组 54 人开始时间: 2024年2月2日最近更新: 2024年2月12日

试验速览

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•1. Military service personnel aged 18-60 years with non-freezing cold injury (NFCI) resulting in painful neuropathy
•2. History of distal symmetric sensory polyneuropathy affecting feet for at least 8 weeks, confirmed on clinical examination and/or sensory testing and assessed on the 11-point pain intensity numerical pain rating scale (NPRS).
•3. Patients with a history of pain intensity equal to or greater than 4 NPRS points are eligible to participate.
•4. The use of systemic analgesics to relieve pain including anti-depressants, anticonvulsants, opioids, salicylates, paracetamol, and non-steroidal anti-inflammatory drugs (NSAIDs) will be permitted, providing any changes are recorded for the entire duration of the study

•1. Participating in another clinical trial or who has done so within 30 days before screening
•2. Additional medical condition or illness that, in the opinion of the Investigator, would interfere with study compliance and/or impair the patient's alcohol or drug abuse) within the previous six months before enrolment
•3. A history of severe allergies or multiple drug allergies and/or reported hypersensitivity to capsaicin
•4. Other conditions that may lead to neuropathic pain or hypersensitivity e.g. diabetes, and HIV
•5. Topical anaesthetic or capsaicin applications, or history of previous treatment with the Capsaicin 8% patch (to minimise unblinding)
•6. Pregnant or nursing mothers will not be included in this study; relevant history will be taken. A pregnancy test will be performed and patients who are pregnant will be excluded from the study.

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