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

Sponsor

Cairo University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05695677

Collaborator

(none)

Enrollment

Locations

Arm

4.9

Anticipated Duration (Months)

Patients Per Site

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Tecar Therapy Efficacy in the Treatment of PDPH	Procedure: Capacitive-Resistive Radiofrequency therapy of the neck muscles	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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.

Actual Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Mar 30, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Tecar treatment sucess	Procedure: Capacitive-Resistive Radiofrequency therapy of the neck muscles Capacitive-Resistive Radiofrequency therapy of the neck muscles as a non-invasive technique for treating PDPH.

Arm

Intervention/Treatment

Other: Tecar treatment sucess

Procedure: Capacitive-Resistive Radiofrequency therapy of the neck muscles

Capacitive-Resistive Radiofrequency therapy of the neck muscles as a non-invasive technique for treating PDPH.

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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 .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Abeer Ahmed	Cairo		Egypt	11562
2	Anesthesia department - Faculty of medicine- Cairo University	Cairo		Egypt

Sponsors and Collaborators

Cairo University

Investigators

Principal Investigator: Abeer Ahmed, MD, kasr Alainy Faculty of medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Abeer Ahmed, MD, Professor, Cairo University

ClinicalTrials.gov Identifier:

NCT05695677

Other Study ID Numbers:

MS-254-2022

First Posted:

Jan 25, 2023

Last Update Posted:

Jan 25, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Post-Dural Puncture Headache

Headache

Study Results

No Results Posted as of Jan 25, 2023