跳至主要内容
临床试验/NCT05695677
NCT05695677招募中不适用

Capacitive-Resistive Radiofrequency Therapy of the Neck Muscles as a Non-invasive Treatment of the Post-dural Puncture Headache After Cesarean Delivery. A Pre-post Study.

Cairo University3 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
3
主要终点
is the rate of Tecar therapy success in treating the PDPH after the first session

研究概览

简要总结

Postdural puncture headache (PDPH) is a frequent complication after neuraxial anaesthesia due to accidental puncture of the dura mater. After spinal anaesthesia, the rate of PDPH may reach up to 28,7% of cases. PDPH is more common in females, especially obstetric patients, young age and more after epidural than spinal anaesthesia because of needle type. PDPH interferes with the patient's ability to resume activities, prolongs the hospital stay, and causes chronic headaches in up to 28% of cases.

Several treatment modalities were described for PDPH. Conservative treatment, an epidural blood patch, peripheral nerve blocks, such as sphenopalatine ganglion block (SPGB) and more excellent occipital nerve block (GONB) using local anaesthetic block or through percutaneous radiofrequency ablation or direct injection of local anaesthetic and steroid directly into the neck muscles; were all proven effective in treating PDPH. Radiofrequency (RF) is a commonly used technique to treat different types of pain, headaches, and musculoskeletal abnormalities. The second-generation non-invasive RF modality was recently developed as Tecar therapy (TECAR: Capacitive and Resistive Energy Transfer). Tecar therapy provided promising results in treating chronic pelvic and postpartum perineal pain. To our knowledge, Tecar therapy efficacy in treating PDPH has not been evaluated before. This study aims to assess the effectiveness of Tecar therapy as a non-invasive technique for treating PDPH. This study hypothesizes that Tecar therapy could be an effective non-invasive technique for treating or reducing PDPH.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • female patients aged over 18 years
  • ASA physical status I or II.
  • scheduled for elective cesarean delivery under spinal anaesthesia
  • who developed PDPH with failed conservative treatment

排除标准

  • Patients with a history of long-standing diabetes.
  • peripheral vascular diseases
  • cervical spine disorders
  • receiving analgesics and anticonvulsant medication .

结局指标

主要结局

is the rate of Tecar therapy success in treating the PDPH after the first session

时间窗: starting from day 2 after developing PDPH and over 5 days.

number of patients with VAS \<4 in sitting position after the first session / total number of patients).

次要结局

未报告次要终点

研究者

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

Abeer Ahmed, MD

Professor

Cairo University

研究点 (3)

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