NCT05695677

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

Status unknown NA Last updated 25 January 2023

What this trial tests

NA trial testing Capacitive-Resistive Radiofrequency therapy of the neck muscles in Tecar Therapy Efficacy in the Treatment of PDPH in 50 participants. Status unknown.

Timeline

1 December 2022

Primary endpoint
30 March 2023

30 April 2023

Quick facts

Lead sponsor	Cairo University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	50
Start date	1 December 2022
Primary completion	30 March 2023
Estimated completion	30 April 2023
Sites	2 locations across Egypt

Drugs / interventions tested

• Capacitive-Resistive Radiofrequency therapy of the neck muscles

Conditions studied

• Tecar Therapy Efficacy in the Treatment of PDPH — all drugs for Tecar Therapy Efficacy in the Treatment of PDPH →

Sponsor

Cairo University

Who can join

Adults 18 to 45, female only, with Tecar Therapy Efficacy in the Treatment of PDPH. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.