Radiofrequency Therapy of the Neck Muscles for Treating the Post-dural Puncture Headache After Cesarean Delivery.

Not Applicable

Recruiting

• Conditions: Tecar Therapy Efficacy in the Treatment of PDPH
• Interventions: Procedure: Capacitive-Resistive Radiofrequency therapy of the neck muscles

• Registration Number: NCT05695677
• Lead Sponsor: Cairo University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-18
• Study Start: 2022-12-01
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-20
• Last Update Submitted: 2023-01-20
• Study First Posted: 2023-01-25
• Last Update Posted: 2023-01-25
• Primary Completion: 2023-03-30
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

• 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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tecar treatment sucess	Capacitive-Resistive Radiofrequency therapy of the neck muscles	-

Primary Outcome Measures

Name	Time	Method
is the rate of Tecar therapy success in treating the PDPH after the first session	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).

Trial Locations

Locations (2)

Abeer Ahmed; 🇪🇬 Cairo, Egypt

Anesthesia department - Faculty of medicine- Cairo University; 🇪🇬 Cairo, Egypt