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临床试验/NCT03396406
NCT03396406已完成不适用

Comparison of Extended Duration Pulsed Radiofrequency Plus Low Temperature Thermal Radiofrequency With Thermal Radiofrequency Alone in Treatment of Recurrent Trigeminal Neuralgia

Assiut University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年8月最近更新:
适应症
干预措施

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
Visual analog pain score

研究概览

简要总结

Forty patients with history of recurrent TN were recruited in Assiut University Hospitals, Pain Unit from 2012 to 2017. Before the study, all patients were given adequate and informative data about the nature of the study, interventional procedure and its possible complications, and a well-informed written consent was obtained from each patients.

详细描述

All interventions were done in a specialized well-equipped unit at Assiut University hospital and continuous hemodynamic monitoring with pulse oximetry, blood pressure and ECG applied for each patient. Light sedation by using midazolam 5mg bolus. In a supine position with slightly extended head and under fluoroscopic control, C arm rotated caudo-cranially and ipsilateraly to produce an oblique submental view and visualize foramen ovale beside the ramus of the mandible. The point of entry varied according to the affected branch, but it ranged from 0.5-1.5 cm from the corner of the mouth. The point of entry cleaned by aseptic solution and anaesthetized with 1% of Lidocaine. C arm has been rotated laterally to confirm the depth of penetration once the needle entered into Meckel's cavity. RF electrode (22-G, 10 cm needle, with a curved 5 mm active tip, Neurotherm 1100) was used and the exact position of the needle confirmed by sensory stimulation, motor stimulation and negative aspiration as the following criteria:-

  1. Sensory stimulation (50 Hz) threshold between 0.1-0.3 V which made paresthesia and/ or tingling in the affected painful area. Patient was awake to respond to the sensory stimulation
  2. Motor stimulation at 2Hz with 0.1-1.5V caused muscle contraction of the lower mandible.

After confirming the position of the RF electrode, each patient received 0.5 ml of 1% of Lidocaine to avoid discomfort during treatment. Then the type of intervention determined by the person who was responsible for randomisation process and who did not involve in assessing eligibility or interventional technique and divided into:-

  • Group A: pulsed radiofrequency was applied for 4 cycles of 120 seconds ( 8 minutes in total) at 45 V and temperature was set at 42 C. then conventional radiofrequency thermal lesion was applied for 3 cycles of 90 seconds at 60 c.
  • Group B: thermal energy was applied gradually for 3 cycles of 90 seconds at 70 C.

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 (Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • • Patient with severe, recurrent TN for more than 6 months, non-satisfactory pain relief with medical treatment or/and intolerable to medical drugs
  • Age more than 18 years old
  • Pain score ≥ 7
  • Patient consent to participate

排除标准

  • • Known concurrent neurological or neurodegenerative diseases such as multiple sclerosis, and myasthenia gravis
  • Breast feeding or pregnant women
  • Advanced malignancy or brain stem tumors
  • Coagulopathy or patients on anticoagulant medications
  • Allergy/ sensitivity to Lidocaine anesthetic or/and non- ionic contrast media
  • Presence of Progressive Motor or sensory deficit in the distribution of trigeminal nerve
  • Active psychological or mental diseases
  • Uncontrolled medical or respiratory conditions
  • Patients who are unwilling to participate

研究组 & 干预措施

PCRF group

Experimental

received Pulsed radiofrequency (PRF) at 42°C for 8 minutes followed by CRF at 60°C for 270s

干预措施: Pulsed radiofrequency (PRF) (Device)

CRF group

Experimental

received sole thermocoagulation at 70°C for 270 s

干预措施: thermocoagulation (Device)

结局指标

主要结局

Visual analog pain score

时间窗: 2 years

The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone

次要结局

  • change in medical treatment(2 years)

研究者

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

Abdelrady S Ibrahim, MD

Assistant professor of Anesthesia and Intensive care

Assiut University

研究点 (2)

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