Radiofrequency Therapy of the Neck Muscles for Treating the Post-dural Puncture Headache After Cesarean Delivery.
Primary Purpose
Tecar Therapy Efficacy in the Treatment of PDPH
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Capacitive-Resistive Radiofrequency therapy of the neck muscles
Sponsored by
About this trial
This is an interventional other trial for Tecar Therapy Efficacy in the Treatment of 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 .
Sites / Locations
- Abeer AhmedRecruiting
- Anesthesia department - Faculty of medicine- Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Tecar treatment sucess
Arm Description
Outcomes
Primary Outcome Measures
is the rate of Tecar therapy success in treating the PDPH after the first session
number of patients with VAS <4 in sitting position after the first session / total number of patients).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05695677
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
March 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tecar Therapy Efficacy in the Treatment of PDPH
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tecar treatment sucess
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Capacitive-Resistive Radiofrequency therapy of the neck muscles
Intervention Description
Capacitive-Resistive Radiofrequency therapy of the neck muscles as a non-invasive technique for treating PDPH.
Primary Outcome Measure Information:
Title
is the rate of Tecar therapy success in treating the PDPH after the first session
Description
number of patients with VAS <4 in sitting position after the first session / total number of patients).
Time Frame
starting from day 2 after developing PDPH and over 5 days.
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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 .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abeer Ahmed, MD
Phone
01005244590
Email
abeer_ahmed@kasralainy.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abeer Ahmed, MD
Organizational Affiliation
kasr Alainy Faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abeer Ahmed
City
Cairo
ZIP/Postal Code
11562
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abeer Ahmed
Email
abeer_ahmed@kasralainy.edu.eg
Facility Name
Anesthesia department - Faculty of medicine- Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abeer Ahmed, Anesthesia lecturer
12. IPD Sharing Statement
Learn more about this trial
Radiofrequency Therapy of the Neck Muscles for Treating the Post-dural Puncture Headache After Cesarean Delivery.
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