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临床试验/NCT03584061
NCT03584061已完成不适用

Treatment of Chronic Postherpetic Pain With Fat Grafting - A Pilot Study

Odense University Hospital2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2018年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Neuropathic pain [LEVEL OF PAIN]

研究概览

简要总结

This study evaluates the possible beneficial effect of fat grafting for post herpetic neuralgia.

详细描述

Herpes Zoster (HZ),is a condition caused by Varizella-Zooster virus (VZV), The disease is caused by reactivation of a latent VZV-infection in the sensory ganglia.

Clinically the condition is characterized by a painful, unilateral, vesicular rash. Pain is the most prominent symptom in around 90% of patients. In 10% of patients this pain remains and becomes chronic.

Post-herpetic neuralgia is a chronic pain syndrome that occurs after the dermal manifestations disappears.

Treatment is complex and mainly topical or systemic. For many patients this is not sufficient and they live with constant pain.

Fat grafting has shown promise in treating several different painful conditions such as post mastectomy pain syndrome, painful scars etc.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age over 18
  • Pain in area of former VZV-infection.
  • Pain present over 3 months after reactivation of VZV and is present at least 4 days a week and of intensity >3 on the VAS-scale.

排除标准

  • Psychiatric illness that could potentially affect the study.
  • Other indication for fat grafting than pain.

结局指标

主要结局

Neuropathic pain [LEVEL OF PAIN]

时间窗: 6 months

Neuropathic Pain Symptom inventory (NPSI), Questionnaire. NPSI consists of 12 items in total: 10 items investigates differential symptoms descriptors and 2 items evaluate spontaneous and paroxysmal spontaneous pain. The tool evaluates mean pain intensity in the last 24h in a verbal numeric scale from zero (no pain) to 10 (worst imaginable pain). Total pain intensity score may be calculated by the sum of the 10 descriptors. The descriptors are: Burning, Squeezing, Pressure, Electric Shocks, Stabbing, Provoked by brushing. Provoked by pressure, Evoked by cold stimulation, Pins and needles, Tingling.

次要结局

  • Quality of life [QUALITY OF LIFE/ SATISFACTION](6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Sollie

Principal investigator, M.D, Dept. of Plastic and Reconstructive Surgery

Odense University Hospital

研究点 (2)

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