Trigeminal NeuralgiaNCT03396406
Treatment of Recurrent Trigeminal Neuralgia by Using Extended Duration of Pulsed Radiofrequency
A study testing Pulsed radiofrequency (PRF) and thermocoagulation in people with Trigeminal Neuralgia, run by Assiut University at 1 site in Egypt.
Trial summary
Forty patients with history of recurrent TN were recruited in Assiut University Hospitals, Pain Unit from 2012 to 2017. Before the study, all patients were given adequate and informative data about the nature of the study, interventional procedure and its possible complications, and a well-informed written consent was… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trigeminal Neuralgia
- What is being tested?
- Pulsed radiofrequency (PRF) and thermocoagulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2012to Sep 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • Patient with severe, recurrent TN for more than 6 months, non-satisfactory pain relief with medical treatment or/and intolerable to medical drugs
- Age more than 18 years old
- Pain score ≥ 7
- Patient consent to participate
Who cannot join
- • Known concurrent neurological or neurodegenerative diseases such as multiple sclerosis, and myasthenia gravis
- Breast feeding or pregnant women
- Advanced malignancy or brain stem tumors
- Coagulopathy or patients on anticoagulant medications
- Allergy/ sensitivity to Lidocaine anesthetic or/and non- ionic contrast media
- Presence of Progressive Motor or sensory deficit in the distribution of trigeminal nerve
Show all 9Show fewer
- Active psychological or mental diseases
- Uncontrolled medical or respiratory conditions
- Patients who are unwilling to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Extended Duration Pulsed Radiofrequency Plus Low Temperature Thermal Radiofrequency With Thermal Radiofrequency Alone in Treatment of Recurrent Trigeminal Neuralgia
Forty patients with history of recurrent TN were recruited in Assiut University Hospitals, Pain Unit from 2012 to 2017. Before the study, all patients were given adequate and informative data about the nature of the study, interventional procedure and its possible complications, and a well-informed written consent was obtained from each patients.
Read the detailed description
All interventions were done in a specialized well-equipped unit at Assiut University hospital and continuous hemodynamic monitoring with pulse oximetry, blood pressure and ECG applied for each patient. Light sedation by using midazolam 5mg bolus. In a supine position with slightly extended head and under fluoroscopic control, C arm rotated caudo-cranially and ipsilateraly to produce an oblique submental view and visualize foramen ovale beside the ramus of the mandible. The point of entry varied according to the affected branch, but it ranged from 0.5-1.5 cm from the corner of the mouth. The point of entry cleaned by aseptic solution and anaesthetized with 1% of Lidocaine. C arm has been rotated laterally to confirm the depth of penetration once the needle entered into Meckel's cavity. RF electrode (22-G, 10 cm needle, with a curved 5 mm active tip, Neurotherm 1100) was used and the exact position of the needle confirmed by sensory stimulation, motor stimulation and negative aspiration as the following criteria:-
- Sensory stimulation (50 Hz) threshold between 0.1-0.3 V which made paresthesia and/ or tingling in the affected painful area. Patient was awake to respond to the sensory stimulation
- Motor stimulation at 2Hz with 0.1-1.5V caused muscle contraction of the lower mandible.
After confirming the position of the RF electrode, each patient received 0.5 ml of 1% of Lidocaine to avoid discomfort during treatment. Then the type of intervention determined by the person who was responsible for randomisation process and who did not involve in assessing eligibility or interventional technique and divided into:-
- Group A: pulsed radiofrequency was applied for 4 cycles of 120 seconds ( 8 minutes in total) at 45 V and temperature was set at 42 C. then conventional radiofrequency thermal lesion was applied for 3 cycles of 90 seconds at 60 c.
- Group B: thermal energy was applied gradually for 3 cycles of 90 seconds at 70 C.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Pulsed radiofrequency (PRF), thermocoagulation
- Keywords
- trigeminal neuralgia, radiofrequency
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed radiofrequency (PRF)Device
received PRF at 42°C for 8 minutes followed by CRF at 60°C for 270s
thermocoagulationDevice
received sole CRF at 70°C for 270 s
| Study group | Role | What they receive |
|---|---|---|
| PCRF group | Experimental | received Pulsed radiofrequency (PRF) at 42°C for 8 minutes followed by CRF at 60°C for 270s Receives: Device: Pulsed radiofrequency (PRF) |
| CRF group | Experimental | received sole thermocoagulation at 70°C for 270 s Receives: Device: thermocoagulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual analog pain score
The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone
Measured: one month
Visual analog pain score
The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone
Measured: 6 months
Visual analog pain score
The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone
Measured: one year
Visual analog pain score
The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone
Measured: 2 years
Secondary outcomes (1)
change in medical treatment
need for tricyclic antidepressant
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study startAug 2012
- Primary completionJun 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Trigeminal NeuralgiaStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrady S Ibrahim, MD, Assiut University
- Investigators
- Abdelrady S Ibrahim, M.D., Principal investigator, Assiut university faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396406
- Sponsor's protocol ID
- IRB0000871244
- Status last verified
- Jan 2018
- First submitted
- 4 Jan 2018
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Elias WJ, Burchiel KJ. Microvascular decompression. Clin J Pain. 2002 Jan-Feb;18(1):35-41. doi: 10.1097/00002508-200201000-00006.
PubMed 11803301Abdel-Rahman KA, Elawamy AM, Mostafa MF, Hasan WS, Herdan R, Osman NM, Ibrahim AS, Aly MG, Ali AS, Abodahab GM. Combined pulsed and thermal radiofrequency versus thermal radiofrequency alone in the treatment of recurrent trigeminal neuralgia after microvascular decompression: A double blinded comparative study. Eur J Pain. 2020 Feb;24(2):338-345. doi: 10.1002/ejp.1489. Epub 2019 Oct 16.
PubMed 31571339
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Extended Duration Pulsed Radiofrequency Plus Low Temperature Thermal Radiofrequency With Thermal Radiofrequency Alone in Treatment of Recurrent Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT03396406
- Acronym / sponsor ID
- IRB0000871244
- Conditions
- Trigeminal Neuralgia
- Keywords
- trigeminal neuralgia, radiofrequency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2012 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 11 Jan 2018 (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.
Forty patients with history of recurrent TN were recruited in Assiut University Hospitals, Pain Unit from 2012 to 2017. Before the study, all patients were given adequate and informative data about the nature of the study, interventional procedure and its possible complications, and a well-informed written consent was obtained from each patients.
Detailed description
All interventions were done in a specialized well-equipped unit at Assiut University hospital and continuous hemodynamic monitoring with pulse oximetry, blood pressure and ECG applied for each patient. Light sedation by using midazolam 5mg bolus. In a supine position with slightly extended head and under fluoroscopic control, C arm rotated caudo-cranially and ipsilateraly to produce an oblique submental view and visualize foramen ovale beside the ramus of the mandible. The point of entry varied according to the affected branch, but it ranged from 0.5-1.5 cm from the corner of the mouth. The point of entry cleaned by aseptic solution and anaesthetized with 1% of Lidocaine. C arm has been rotated laterally to confirm the depth of penetration once the needle entered into Meckel's cavity. RF electrode (22-G, 10 cm needle, with a curved 5 mm active tip, Neurotherm 1100) was used and the exact position of the needle confirmed by sensory stimulation, motor stimulation and negative aspiration as the following criteria:-
- Sensory stimulation (50 Hz) threshold between 0.1-0.3 V which made paresthesia and/ or tingling in the affected painful area. Patient was awake to respond to the sensory stimulation
- Motor stimulation at 2Hz with 0.1-1.5V caused muscle contraction of the lower mandible.
After confirming the position of the RF electrode, each patient received 0.5 ml of 1% of Lidocaine to avoid discomfort during treatment. Then the type of intervention determined by the person who was responsible for randomisation process and who did not involve in assessing eligibility or interventional technique and divided into:-
- Group A: pulsed radiofrequency was applied for 4 cycles of 120 seconds ( 8 minutes in total) at 45 V and temperature was set at 42 C. then conventional radiofrequency thermal lesion was applied for 3 cycles of 90 seconds at 60 c.
- Group B: thermal energy was applied gradually for 3 cycles of 90 seconds at 70 C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCRF group | Experimental | Device: Pulsed radiofrequency (PRF)received Pulsed radiofrequency (PRF) at 42°C for 8 minutes followed by CRF at 60°C for 270s |
| CRF group | Experimental | Device: thermocoagulationreceived sole thermocoagulation at 70°C for 270 s |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- • Patient with severe, recurrent TN for more than 6 months, non-satisfactory pain relief with medical treatment or/and intolerable to medical drugs
Key exclusion criteria (9 listed)
- • Known concurrent neurological or neurodegenerative diseases such as multiple sclerosis, and myasthenia gravis
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)received PRF at 42°C for 8 minutes followed by CRF at 60°C for 270s | Device | PCRF group |
| thermocoagulationreceived sole CRF at 70°C for 270 s | Device | CRF group |
Primary outcome
Visual analog pain score
Time frame: one month
The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone
Visual analog pain score
Time frame: 6 months
The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone
Visual analog pain score
Time frame: one year
The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone
Visual analog pain score
Time frame: 2 years
The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone
1 secondary outcome
change in medical treatment
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Background: PubMed 11803301Elias WJ, Burchiel KJ. Microvascular decompression. Clin J Pain. 2002 Jan-Feb;18(1):35-41. doi: 10.1097/00002508-200201000-00006.
- Derived from this study: PubMed 31571339Abdel-Rahman KA, Elawamy AM, Mostafa MF, Hasan WS, Herdan R, Osman NM, Ibrahim AS, Aly MG, Ali AS, Abodahab GM. Combined pulsed and thermal radiofrequency versus thermal radiofrequency alone in the treatment of recurrent trigeminal neuralgia after microvascular decompression: A double blinded comparative study. Eur J Pain. 2020 Feb;24(2):338-345. doi: 10.1002/ejp.1489. Epub 2019 Oct 16.
- Individual participant dataSharing planned: Undecided
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. This study is not recruiting at the moment.
Abdelrady S Ibrahim, M.D. principal investigator
Assiut university faculty of medicine
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 thermocoagulation in people with Trigeminal Neuralgia, run by Assiut 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 4 inclusion and 9 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: finished, as of the sponsor's last update on 11 Jan 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual analog pain score (time frame: one month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03396406, which also lists 2 linked publications.
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 11 Jan 2018.