Clinical trial NCT05695677: Radiofrequency Therapy of the Neck Muscles for Treating the Post-dural Puncture Headache After Cesarean Delivery.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tecar Therapy Efficacy in the Treatment of PDPH
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-01-25
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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 .

Primary outcomes:
measure: is the rate of Tecar therapy success in treating the PDPH after the first session
timeFrame: starting from day 2 after developing PDPH and over 5 days.
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Abeer Ahmed
city: Cairo
country: Egypt
facility: Anesthesia department - Faculty of medicine- Cairo University
Study officials:
affiliation: kasr Alainy Faculty of medicine
name: Abeer Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References: