Tecar Therapy Efficacy in the Treatment of PDPHNCT05695677
Radiofrequency Therapy of the Neck Muscles for Treating the Post-dural Puncture Headache After Cesarean Delivery.
A study testing Capacitive-Resistive Radiofrequency therapy of the neck muscles in people with Tecar Therapy Efficacy in the Treatment of PDPH, run by Cairo University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Tecar Therapy Efficacy in the Treatment of PDPH
- What is being tested?
- Capacitive-Resistive Radiofrequency therapy of the neck muscles
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Dec 2022to 30 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Patients with a history of long-standing diabetes.
- peripheral vascular diseases
- cervical spine disorders
- receiving analgesics and anticonvulsant medication .
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites, 2 recruiting
- Recruiting
Abeer Ahmed
Cairo, 11562
Abeer Ahmed, abeer_ahmed@kasralainy.edu.eg
- Recruiting
Anesthesia department - Faculty of medicine- Cairo University
Cairo
Abeer Ahmed, Anesthesia lecturer
About this study
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.
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.
- Being tested
- Capacitive-Resistive Radiofrequency therapy of the neck muscles
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capacitive-Resistive Radiofrequency therapy of the neck musclesProcedure or surgery
Capacitive-Resistive Radiofrequency therapy of the neck muscles as a non-invasive technique for treating PDPH.
| Study group | Role | What they receive |
|---|---|---|
| Tecar treatment sucess | Other | Not described Receives: Procedure: Capacitive-Resistive Radiofrequency therapy of the neck muscles |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: starting from day 2 after developing PDPH and over 5 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Dec 2022
- Primary completion30 Mar 2023 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tecar Therapy Efficacy in the Treatment of PDPHStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abeer Ahmed, MD, Cairo University
- Investigators
- Abeer Ahmed, MD, Principal investigator, kasr Alainy Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05695677
- Sponsor's protocol ID
- MS-254-2022
- Status last verified
- Jan 2023
- First submitted
- 18 Oct 2022
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05695677
- Acronym / sponsor ID
- MS-254-2022
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 30 Mar 2023 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 25 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tecar treatment sucess | Other | Procedure: Capacitive-Resistive Radiofrequency therapy of the neck muscles |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Patients with a history of long-standing diabetes.
- peripheral vascular diseases
- cervical spine disorders
- receiving analgesics and anticonvulsant medication .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Capacitive-Resistive Radiofrequency therapy of the neck musclesCapacitive-Resistive Radiofrequency therapy of the neck muscles as a non-invasive technique for treating PDPH. | Procedure or surgery | Tecar treatment sucess |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abeer Ahmed, MD principal investigator
kasr Alainy Faculty of medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Capacitive-Resistive Radiofrequency therapy of the neck muscles in people with Tecar Therapy Efficacy in the Treatment of PDPH, run by Cairo University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abeer Ahmed, MD (01005244590, abeer_ahmed@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.