- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05695677
Radiofrequency Therapy of the Neck Muscles for Treating the Post-dural Puncture Headache After Cesarean Delivery.
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.
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Abeer Ahmed, MD
- Phone Number: 01005244590
- Email: abeer_ahmed@kasralainy.edu.eg
Study Locations
-
-
-
Cairo, Egypt, 11562
- Recruiting
- Abeer Ahmed
-
Contact:
- Abeer Ahmed
- Email: abeer_ahmed@kasralainy.edu.eg
-
Cairo, Egypt
- Recruiting
- Anesthesia department - Faculty of medicine- Cairo University
-
Principal Investigator:
- Abeer Ahmed, Anesthesia lecturer
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Tecar treatment sucess
|
Capacitive-Resistive Radiofrequency therapy of the neck muscles as a non-invasive technique for treating PDPH.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
is the rate of Tecar therapy success in treating the PDPH after the first session
Time Frame: 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).
|
starting from day 2 after developing PDPH and over 5 days.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Abeer Ahmed, MD, Kasr Alainy Faculty of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS-254-2022
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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