Trigeminal NeuralgiaNCT06684275
Comparison of Pulsed and Thermal Radiofrequency for Trigeminal Neuralgia
A study testing Pulsed Radiofrequency (PRF) and Pulsed and Thermal Radiofrequency (PRF + TRF) in people with Trigeminal Neuralgia, run by Zagazig University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to compare the effectiveness of Pulsed Radiofrequency (PRF) with Pulsed and Thermal Radiofrequency (PRF + TRF) in treating Trigeminal Neuralgia (TN) in adults. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Pulsed Radiofrequency (PRF) and Pulsed and Thermal Radiofrequency (PRF + TRF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Nov 2024to 10 Apr 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-60 years.
- Diagnosis of classical trigeminal neuralgia, as per the International Classification of Headache Disorders criteria
- Patients experiencing unilateral, episodic facial pain for at least six months with a Numeric Rating Scale (NRS) score greater than 6, despite medical treatment.
- Able to provide informed consent.
- Agree to follow the study procedures and attend follow-up visits.
Who cannot join
- Patients with secondary trigeminal neuralgia (e.g., due to tumors, multiple sclerosis).
- Previous surgery or radiofrequency treatment for trigeminal neuralgia.
- Pregnant or breastfeeding women.
- Known allergies to anesthetics or other agents used in the procedure.
- Significant psychiatric disorders that may interfere with pain assessment or study participation.
- Coagulopathy or use of anticoagulants that contraindicate the procedure.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Zagazig University, Faculty of Medicine
Zagazig, Sharqia Province, 44519
Ahmed A Bessar, MD, PhD, +201000089595, ahmedawadbessar@gmail.com
About this study
Official title: Comparison of Pulsed and Thermal Radiofrequency for the Treatment of Trigeminal Neuralgia: A Randomized Controlled Trial
The goal of this clinical trial is to compare the effectiveness of Pulsed Radiofrequency (PRF) with Pulsed and Thermal Radiofrequency (PRF + TRF) in treating Trigeminal Neuralgia (TN) in adults.
The main questions it aims to answer are:
Read more
- Does PRF or PRF + TRF provide better pain relief for patients with trigeminal neuralgia?
- What is the safety profile and complication rate of PRF versus PRF + TRF?
Researchers will compare the effects of PRF and PRF + TRF to see if thermal lesioning in addition to pulsed RF provides superior long-term pain relief and reduces the need for analgesic medication.
Participants will:
- Undergo either PRF or PRF + TRF treatment targeting the trigeminal nerve.
- Be assessed for pain relief, functional status, and adverse events over a 3-month follow-up period.
Read the detailed description
This study is a randomized controlled trial designed to evaluate the efficacy and safety of Pulsed Radiofrequency (PRF) versus Pulsed and Thermal Radiofrequency (PRF + TRF) for treating Trigeminal Neuralgia (TN). Trigeminal neuralgia is a debilitating chronic pain condition that affects the trigeminal nerve, causing intense facial pain.
The study will enroll participants with TN, randomized into two groups:
- Group 1 (PRF): Patients will receive pulsed radiofrequency treatment with parameters set to standard levels for pain relief.
- Group 2 (PRF + TRF): Patients will receive pulsed radiofrequency combined with thermal lesioning (60-70°C) to target the trigeminal nerve.
Both procedures will be performed under aseptic conditions with appropriate monitoring and anesthesia. The primary outcome will be pain reduction measured using the Numeric Rating Scale (NRS) and Visual Analog Scale (VAS) over a 12-week period. Secondary outcomes include changes in medication consumption assessed by the Medication Quantification Scale III (MQS III) and the recording of procedure-related adverse events.
Participants will undergo follow-up assessments at Week 1, Week 4, and Week 12 post-treatment.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Pulsed Radiofrequency (PRF), Pulsed and Thermal Radiofrequency (PRF + TRF)
- Keywords
- Trigeminal Neuralgia, Pulsed Radiofrequency, Thermal Radiofrequency, Neuropathic Pain, Facial Pain, Radiofrequency Ablation
- Medical subject headings
- Trigeminal Neuralgia, Neuralgia, Facial Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed Radiofrequency (PRF)Procedure or surgery
Participants will receive pulsed radiofrequency (PRF) treatment targeting the trigeminal nerve to manage pain associated with trigeminal neuralgia. This non-ablative technique uses electrical pulses to modulate nerve function, aiming to provide pain relief without creating a thermal lesion.
Pulsed and Thermal Radiofrequency (PRF + TRF)Procedure or surgery
Participants will receive a combination of pulsed radiofrequency (PRF) and thermal radiofrequency (TRF) treatments targeting the trigeminal nerve. This approach combines the non-ablative effects of PRF with the thermal lesioning of TRF to provide long-term pain relief for trigeminal neuralgia.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed Radiofrequency (PRF) | Experimental | Participants in this group will receive pulsed radiofrequency (PRF) treatment targeted to the trigeminal nerve. The procedure will involve a standard PRF protocol. Receives: Procedure: Pulsed Radiofrequency (PRF) |
| Pulsed and Thermal Radiofrequency (PRF + TRF) | Active comparator | Participants in this group will receive a combination of pulsed radiofrequency (PRF) and thermal radiofrequency (TRF). The TRF procedure will involve creating a thermal lesion at a target temperature in addition to the standard PRF treatment protocol. Receives: Procedure: Pulsed and Thermal Radiofrequency (PRF + TRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Relief - Numeric Rating Scale (NRS)
The primary outcome measure will be the level of pain relief, assessed using the Numeric Rating Scale (NRS), a scale from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain." Pain levels will be recorded at baseline (pre-procedure), and at 1 week, 4 weeks, and 12 weeks post-procedure.
Measured: Baseline, 1 week, 4 weeks, and 12 weeks post-procedure
Pain Relief - Visual Analog Scale (VAS)
Additionally, pain relief will be assessed using the Visual Analog Scale (VAS), a continuous scale ranging from 0 to 100 mm, where 0 represents "no pain" and 100 represents "worst possible pain." Pain levels will be recorded at baseline, 1 week, 4 weeks, and 12 weeks post-procedure.
Measured: Baseline, 1 week, 4 weeks, and 12 weeks post-procedure
Secondary outcomes (2)
Medication Consumption
Changes in medication consumption will be assessed using the Medication Quantification Scale III (MQS III) at 12 weeks post-procedure. This measure evaluates the impact of the interventions on the need for medications to manage trigeminal neuralgia.
Measured: 12 weeks post-procedure
Procedure-Related Adverse Events
Adverse events related to the interventions will be systematically recorded to evaluate the safety profile. Adverse events will be monitored and recorded immediately post-procedure and at follow-up visits at 1 week, 4 weeks, and 12 weeks post-procedure.
Measured: Immediately post-procedure, 1 week, 4 weeks, and 12 weeks post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start10 Nov 2024
- Primary completion10 Mar 2025 (estimated)
- Study completion10 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of the two groups (PRF or PRF + TRF)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ahmed Awad Bessar, Zagazig University
- Investigators
- Ahmed A Bessar, MD, PhD, Principal investigator, Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684275
- Sponsor's protocol ID
- PRF-TRF-TN
- Status last verified
- Dec 2024
- First submitted
- 10 Nov 2024
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At this time, there is no plan to share individual participant data (IPD) with other researchers. This decision is based on considerations related to patient confidentiality, data privacy concerns, and the absence of a current infrastructure for secure data sharing. The primary results of the study will be published in peer-reviewed journals and presented at scientific conferences, ensuring that the findings are accessible to the broader research community.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Pulsed and Thermal Radiofrequency for the Treatment of Trigeminal Neuralgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06684275
- Acronym / sponsor ID
- PRF-TRF-TN
- Conditions
- Trigeminal Neuralgia
- Keywords
- Trigeminal Neuralgia, Pulsed Radiofrequency, Thermal Radiofrequency, Neuropathic Pain, Facial Pain, Radiofrequency Ablation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 10 Nov 2024 (actual)
- Primary completion
- 10 Mar 2025 (estimated)
- Study completion
- 10 Apr 2025 (estimated)
- First posted
- 12 Nov 2024 (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.
The goal of this clinical trial is to compare the effectiveness of Pulsed Radiofrequency (PRF) with Pulsed and Thermal Radiofrequency (PRF + TRF) in treating Trigeminal Neuralgia (TN) in adults.
The main questions it aims to answer are:
- Does PRF or PRF + TRF provide better pain relief for patients with trigeminal neuralgia?
- What is the safety profile and complication rate of PRF versus PRF + TRF?
Researchers will compare the effects of PRF and PRF + TRF to see if thermal lesioning in addition to pulsed RF provides superior long-term pain relief and reduces the need for analgesic medication.
Participants will:
- Undergo either PRF or PRF + TRF treatment targeting the trigeminal nerve.
- Be assessed for pain relief, functional status, and adverse events over a 3-month follow-up period.
Detailed description
This study is a randomized controlled trial designed to evaluate the efficacy and safety of Pulsed Radiofrequency (PRF) versus Pulsed and Thermal Radiofrequency (PRF + TRF) for treating Trigeminal Neuralgia (TN). Trigeminal neuralgia is a debilitating chronic pain condition that affects the trigeminal nerve, causing intense facial pain.
The study will enroll participants with TN, randomized into two groups:
- Group 1 (PRF): Patients will receive pulsed radiofrequency treatment with parameters set to standard levels for pain relief.
- Group 2 (PRF + TRF): Patients will receive pulsed radiofrequency combined with thermal lesioning (60-70°C) to target the trigeminal nerve.
Both procedures will be performed under aseptic conditions with appropriate monitoring and anesthesia. The primary outcome will be pain reduction measured using the Numeric Rating Scale (NRS) and Visual Analog Scale (VAS) over a 12-week period. Secondary outcomes include changes in medication consumption assessed by the Medication Quantification Scale III (MQS III) and the recording of procedure-related adverse events.
Participants will undergo follow-up assessments at Week 1, Week 4, and Week 12 post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to one of the two groups (PRF or PRF + TRF)
| Arm | Type | Receives |
|---|---|---|
| Pulsed Radiofrequency (PRF) | Experimental | Procedure: Pulsed Radiofrequency (PRF)Participants in this group will receive pulsed radiofrequency (PRF) treatment targeted to the trigeminal nerve. The procedure will involve a standard PRF protocol. |
| Pulsed and Thermal Radiofrequency (PRF + TRF) | Active comparator | Procedure: Pulsed and Thermal Radiofrequency (PRF + TRF)Participants in this group will receive a combination of pulsed radiofrequency (PRF) and thermal radiofrequency (TRF). The TRF procedure will involve creating a thermal lesion at a target temperature in addition to the standard PRF treatment protocol. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults aged 18-60 years.
- Diagnosis of classical trigeminal neuralgia, as per the International Classification of Headache Disorders criteria
- Patients experiencing unilateral, episodic facial pain for at least six months with a Numeric Rating Scale (NRS) score greater than 6, despite medical treatment.
- Able to provide informed consent.
- Agree to follow the study procedures and attend follow-up visits.
Key exclusion criteria (6 listed)
- Patients with secondary trigeminal neuralgia (e.g., due to tumors, multiple sclerosis).
- Previous surgery or radiofrequency treatment for trigeminal neuralgia.
- Pregnant or breastfeeding women.
- Known allergies to anesthetics or other agents used in the procedure.
- Significant psychiatric disorders that may interfere with pain assessment or study participation.
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 |
|---|---|---|
| Pulsed Radiofrequency (PRF)Participants will receive pulsed radiofrequency (PRF) treatment targeting the trigeminal nerve to manage pain associated with trigeminal neuralgia. This non-ablative technique uses electrical pulses to modulate nerve function, aiming to provide pain relief without creating a thermal lesion. | Procedure or surgery | Pulsed Radiofrequency (PRF) |
| Pulsed and Thermal Radiofrequency (PRF + TRF)Participants will receive a combination of pulsed radiofrequency (PRF) and thermal radiofrequency (TRF) treatments targeting the trigeminal nerve. This approach combines the non-ablative effects of PRF with the thermal lesioning of TRF to provide long-term pain relief for trigeminal neuralgia. | Procedure or surgery | Pulsed and Thermal Radiofrequency (PRF + TRF) |
Primary outcome
Pain Relief - Numeric Rating Scale (NRS)
Time frame: Baseline, 1 week, 4 weeks, and 12 weeks post-procedure
The primary outcome measure will be the level of pain relief, assessed using the Numeric Rating Scale (NRS), a scale from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain." Pain levels will be recorded at baseline (pre-procedure), and at 1 week, 4 weeks, and 12 weeks post-procedure.
Pain Relief - Visual Analog Scale (VAS)
Time frame: Baseline, 1 week, 4 weeks, and 12 weeks post-procedure
Additionally, pain relief will be assessed using the Visual Analog Scale (VAS), a continuous scale ranging from 0 to 100 mm, where 0 represents "no pain" and 100 represents "worst possible pain." Pain levels will be recorded at baseline, 1 week, 4 weeks, and 12 weeks post-procedure.
2 secondary outcomes
Medication Consumption
Time frame: 12 weeks post-procedure
Procedure-Related Adverse Events
Time frame: Immediately post-procedure, 1 week, 4 weeks, and 12 weeks post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Individual participant dataSharing planned: No. At this time, there is no plan to share individual participant data (IPD) with other researchers. This decision is based on considerations related to patient confidentiality, data privacy concerns, and the absence of a current infrastructure for secure data sharing. The primary results of the study will be published in peer-reviewed journals and presented at scientific conferences, ensuring that the findings are accessible to the broader research community.
Related trials for Trigeminal Neuralgia
RecruitingPhase 2
Effectiveness of Phenotype-based Pain Management Guidelines for Head and Neck Cancer Related Pain: a Pilot Study
Cancer Pain, Orofacial Pain
RecruitingObservational study
Trigeminal Neuralgia Electrophysiology
Trigeminal Neuralgia
RecruitingEarly Phase 1
Trigeminal Evoked Responses to Improve Rhizotomy
Trigeminal Neuralgia, Rhizotomy
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm
RecruitingPhase 1/2
RP-008 in Combination With Daily Oral Varenicline for the Treatment of Trigeminal Neuralgia
Trigeminal Neuralgia
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.
Ahmed A Bessar, MD, PhD principal investigator
Assistant Professor of Diagnostic and Interventional Radiology, Zagazig Uni.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulsed Radiofrequency (PRF) and Pulsed and Thermal Radiofrequency (PRF + TRF) in people with Trigeminal Neuralgia, run by Zagazig University at 1 site 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ahmed A Bessar, MD, PhD (+201000089595, Ahmedawadbessar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Relief - Numeric Rating Scale (NRS) (time frame: Baseline, 1 week, 4 weeks, and 12 weeks post-procedure). The study lists 2 primary outcomes in all. 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 31 Dec 2024.