Effectiveness and Durability of Combined Application of Pulsed Radiofrequency and a Steroid to the Dorsal Root Ganglion for Postherpetic Neuralgia: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Numerical rating scale
研究概览
简要总结
Recently, the use of pulsed radiofrequency has increased in many chronic pain conditions, including trigeminal neuralgia, chronic spinal pain, musculoskeletal pain, and it was recently used effectively for postherpetic neuralgia. Transforaminal epidural steroid injection has been proven in previous studies to provide effective analgesia for cases of herpes zoster-related pain. We hypothesize that the combined use of pulsed RF and steroid injection applied to the DRG may achieve better outcomes than the use of epidural steroid injection alone.
详细描述
Varicella-zoster virus reactivates in sensory ganglia as the dorsal root ganglion (DRG). The DRG contains many receptor channels and is an important region for pain signal transduction. Sustained abnormal electrical activity to the spinal cord via the DRG in acute herpes zoster can result in neuropathic conditions such as postherpetic neuralgia (PHN). Postherpetic neuralgia (PHN) is the final stage of varicella-zoster infection and is manifested as severe refractory neuropathic pain. Preventing the transition of herpes zoster-related pain to PHN is a very important therapeutic principle for patients at an early stage, especially for older patients. The exact discriminative time point for PHN has not yet been standardized. Various criteria have been used, from 30 days to 180 days after zoster onset. If pain persists for more than 180 days after zoster onset, the likelihood of pain reduction is very low and such a condition is considered "well established" PHN. Therefore, it is advisable to actively attempt various treatment modalities for pain control before the condition progresses to a recalcitrant state. Pulsed radiofrequency (PRF) is a variant of thermal radiofrequency that applies pulsed current to limit heat generation to less than 42˚C, creating a little risk of thermal or nerve injury. Recently, the use of PRF has increased in many chronic pain conditions, including trigeminal neuralgia, chronic spinal pain, musculoskeletal pain, and it was recently used effectively for postherpetic neuralgia. Transforaminal epidural steroid injection has been proven in previous studies to provide effective analgesia for cases of herpes zoster-related pain. We hypothesize that combined use of pulsed RF and steroid injection applied to the DRG may achieve a better outcome than use of epidural steroid injection alone.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients with ASA I&II status
- •Thoracic zoster related pain
- •less than three months duration from the appearance of shingles
排除标准
- •coagulopathy
- •local infection
- •patient refusal
- •Diabetes Melliteus
结局指标
主要结局
Numerical rating scale
时间窗: Up to 6 months after the intervention
Numerical rating scale (the 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") to be recorded before intervention and at one week, 1 month , 2 months, and 3 months and 6 months after intervention.
次要结局
未报告次要终点
研究者
Mahmoud Mohammed Alseoudy
Lecturer of anesthesia, ICU & pain management; Faculty of Medicine
Mansoura University
