Pain, ChronicNCT04864964
the Value of Sensory Index in Trigeminal Neuralgia
A study testing combined conventional and pulsed radiofrequency (CCPRF) in people with Pain, Chronic, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial summary
Interventional therapies for Trigeminal Neuralgia are of variable efficacy and safety, and have different results for different periods of time before the recurrence of symptoms. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Chronic
- What is being tested?
- combined conventional and pulsed radiofrequency (CCPRF)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2014to 15 Jul 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with trigeminal neuralgia, diagnosed in accordance with the International Headache Society (7) and with a visual analogue score (VAS) for pain of at least 7 or more for a minimum of 3 months before the intervention .
- Patients on a stable analgesic regimen for 2 weeks (consisting of at least two analgesics, including anticonvulsants) before the intervention .
- Patients examined by use of MRI/A of the brain to exclude secondary neuralgia.
Who cannot join
- Patients with severe mental or psychiatric disorders
- Patients with history of drug abuse, high intracranial tension and history of MVD, SGK, balloon compression, RF treatment, or glycerol injection
- The possibility of vascular loop compression and other causes of TN
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of Sensory Index in Predicting the Success of Radiofrequency Treatment of Trigeminal Neuralgia: A Retrospective Study
Interventional therapies for Trigeminal Neuralgia are of variable efficacy and safety, and have different results for different periods of time before the recurrence of symptoms. Interventional therapy for TN is either destructive with trigeminal nerve sensory function destroyed intentionally or non-destructive with decompression of the trigeminal nerve and preservation of its regular function. The most common procedures in treating TN pain are the use of radiofrequency (RF). the aim of this study is to assess the possible value of motor index as a prediction of success of radiofrequency lesioning of the Gasserian ganglion during treatment of trigeminal neuralgia.
Read the detailed description
Trigeminal neuralgia (TN) is defined by the International Headache Society (IHS) as "unilateral disorder characterized by brief electric shock-like pains, abrupt in onset and termination, and limited to the distribution of one or more divisions of the trigeminal nerve". It is considered the worst type of facial pain and described as intense, sharp, stabbing, and shooting like electric shock pain. It can be triggered by touch, chewing, laughing, shaving or face wash .
The IHS suggests a classification of TN as either classic (essential or idiopathic) TN (CTN) or symptomatic TN (STN; pain indistinguishable from that of CTN, but caused by a demonstrable structural lesion other than vascular compression).Treatment of TN is conservative, surgical or interventional. Pharmacotherapy with carbamazepine is tried early in cases of TN but has many side effects .Other medications can be used in the treatment of TN, include oxycarbazepine, gabapentin, pregabalin, baclofen, valproate, clonazepam, phenytoin, and lamotrigime .
The most clinically appropriate treatment includes surgical microvascular decompression (MVD), stereotactic radiation therapy, gamma knife (SGK), percutaneous balloon decompression, percutaneous glycerol rhizolysis, percutaneous radiofrequency (RF) of the Gasserian ganglion (GG), and GG stimulation and neuromodulation. Interventional therapies for TN are of variable efficacy and safety, and have different results for different periods of time before the recurrence of symptoms. Interventional therapy for TN is either destructive with trigeminal nerve sensory function destroyed intentionally or non-destructive with decompression of the trigeminalnerve and preservation of its regular function. The most common procedures in treating TN pain are the use of radiofrequency (RF) .
Radiofrequency thermos-coagulation of the GG is thought to selectively destroy the pain fibers by thermos-coagulation at > 65°C , that helps reduce pain and prevent triggering, but can cause bothersome dysesthesia. Another method, pulsed radiofrequency (PRF) which defined as the delivery of short pulses of RF via a needle tip, thereby a short exposure at the same temperature will result in less thermal tissue destruction (6).
Combined conventional and pulsed radiofrequency (CCPRF) achieved comparable pain relief to PRF treatment alone in patients with chronic pain, the combination of PRF and CRF would increase the effect of CRF and reduce the need for long-duration CRF (LCRF) and its attendant side effects .
The main objective of this study is to assess the possible value of motor index as a prediction of success of radiofrequency lesioning of the Gasserian ganglion during treatment of trigeminal neuralgia.
- Conditions
- Pain, Chronic
- Being tested
- combined conventional and pulsed radiofrequency (CCPRF)
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined conventional and pulsed radiofrequency (CCPRF)Procedure or surgery
Patients with trigeminal neuralgia who underwent combined conventional and pulsed radiofrequency (CCPRF) for treatment of pain.
| Study group | Role | What they receive |
|---|---|---|
| combined conventional and pulsed radiofrequency of trigeminal nerve nucleus | Other | The technique of the CCPRF is described as follows;
1. the classic Hartle technique is used to reach the Gasserian ganglion
2. Sensory stimulation with the RF equipment is conducted and parathesia of the affected branch is achieved at 0.1-0.2 V (50 Hz), keeping in mind that the mandibular part of the Gasserian ganglion is ventrolateral and the ophthalmic rootlets are postrolateral. Motor pre-stimulation (2 Hz) is achieved with masseter contraction at 0.1-0.3 V .
3. After sensory and motor stimulation, RF therapy is conducted by use of the RF generator , in the sequence:
* Conventional RF 1st lesion at 60 °C for 60 s then 2nd lesion at 65°C for 60 seconds then 3rd lesion at 70°C for 60 seconds
* Finally, PRF is applied for 360 second repeated at 45 V, with a pulse width of 10 ms and a pulse frequency of 4 Hz. The cut-off needle tip temperature is set at 42 °C.
4. Before withdrawal of needle 1 cc xylocaine 1% + 0.5 cc dexamethasone 4mg to be given . Receives: Procedure: combined conventional and pulsed radiofrequency (CCPRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor index
Change of the visual analogue scale score, from 0 to 100 , where 100 means worst pain
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start1 May 2014
- Primary completion28 Oct 2019
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, ChronicStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ehab Hanafy Shaker, National Cancer Institute, Egypt
- Investigators
- Ehab H Shaker, Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864964
- Sponsor's protocol ID
- Ehab-Hossam trigeminal
- Status last verified
- Nov 2021
- First submitted
- 25 Apr 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: contacts personal details are not planned to be shared but the results can be shared after publication
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Sensory Index in Predicting the Success of Radiofrequency Treatment of Trigeminal Neuralgia: A Retrospective Study
- ClinicalTrials.gov ID
- NCT04864964
- Acronym / sponsor ID
- Ehab-Hossam trigeminal
- Conditions
- Pain, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 1 May 2014 (actual)
- Primary completion
- 28 Oct 2019 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 29 Apr 2021 (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.
Interventional therapies for Trigeminal Neuralgia are of variable efficacy and safety, and have different results for different periods of time before the recurrence of symptoms. Interventional therapy for TN is either destructive with trigeminal nerve sensory function destroyed intentionally or non-destructive with decompression of the trigeminal nerve and preservation of its regular function. The most common procedures in treating TN pain are the use of radiofrequency (RF). the aim of this study is to assess the possible value of motor index as a prediction of success of radiofrequency lesioning of the Gasserian ganglion during treatment of trigeminal neuralgia.
Detailed description
Trigeminal neuralgia (TN) is defined by the International Headache Society (IHS) as "unilateral disorder characterized by brief electric shock-like pains, abrupt in onset and termination, and limited to the distribution of one or more divisions of the trigeminal nerve". It is considered the worst type of facial pain and described as intense, sharp, stabbing, and shooting like electric shock pain. It can be triggered by touch, chewing, laughing, shaving or face wash .
The IHS suggests a classification of TN as either classic (essential or idiopathic) TN (CTN) or symptomatic TN (STN; pain indistinguishable from that of CTN, but caused by a demonstrable structural lesion other than vascular compression).Treatment of TN is conservative, surgical or interventional. Pharmacotherapy with carbamazepine is tried early in cases of TN but has many side effects .Other medications can be used in the treatment of TN, include oxycarbazepine, gabapentin, pregabalin, baclofen, valproate, clonazepam, phenytoin, and lamotrigime .
The most clinically appropriate treatment includes surgical microvascular decompression (MVD), stereotactic radiation therapy, gamma knife (SGK), percutaneous balloon decompression, percutaneous glycerol rhizolysis, percutaneous radiofrequency (RF) of the Gasserian ganglion (GG), and GG stimulation and neuromodulation. Interventional therapies for TN are of variable efficacy and safety, and have different results for different periods of time before the recurrence of symptoms. Interventional therapy for TN is either destructive with trigeminal nerve sensory function destroyed intentionally or non-destructive with decompression of the trigeminalnerve and preservation of its regular function. The most common procedures in treating TN pain are the use of radiofrequency (RF) .
Radiofrequency thermos-coagulation of the GG is thought to selectively destroy the pain fibers by thermos-coagulation at > 65°C , that helps reduce pain and prevent triggering, but can cause bothersome dysesthesia. Another method, pulsed radiofrequency (PRF) which defined as the delivery of short pulses of RF via a needle tip, thereby a short exposure at the same temperature will result in less thermal tissue destruction (6).
Combined conventional and pulsed radiofrequency (CCPRF) achieved comparable pain relief to PRF treatment alone in patients with chronic pain, the combination of PRF and CRF would increase the effect of CRF and reduce the need for long-duration CRF (LCRF) and its attendant side effects .
The main objective of this study is to assess the possible value of motor index as a prediction of success of radiofrequency lesioning of the Gasserian ganglion during treatment of trigeminal neuralgia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| combined conventional and pulsed radiofrequency of trigeminal nerve nucleus | Other | Procedure: combined conventional and pulsed radiofrequency (CCPRF)The technique of the CCPRF is described as follows; 1. the classic Hartle technique is used to reach the Gasserian ganglion 2. Sensory stimulation with the RF equipment is conducted and parathesia of the affected branch is achieved at 0.1-0.2 V (50 Hz), keeping in mind that the mandibular part of the Gasserian ganglion is ventrolateral and the ophthalmic rootlets are postrolateral. Motor pre-stimulation (2 Hz) is achieved with masseter contraction at 0.1-0.3 V . 3. After sensory and motor stimulation, RF therapy is conducted by use of the RF generator , in the sequence: * Conventional RF 1st lesion at 60 °C for 60 s then 2nd lesion at 65°C for 60 seconds then 3rd lesion at 70°C for 60 seconds * Finally, PRF is applied for 360 second repeated at 45 V, with a pulse width of 10 ms and a pulse frequency of 4 Hz. The cut-off needle tip temperature is set at 42 °C. 4. Before withdrawal of needle 1 cc xylocaine 1% + 0.5 cc dexamethasone 4mg to be given . |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with trigeminal neuralgia, diagnosed in accordance with the International Headache Society (7) and with a visual analogue score (VAS) for pain of at least 7 or more for a minimum of 3 months before the intervention .
- Patients on a stable analgesic regimen for 2 weeks (consisting of at least two analgesics, including anticonvulsants) before the intervention .
- Patients examined by use of MRI/A of the brain to exclude secondary neuralgia.
Key exclusion criteria (3 listed)
- Patients with severe mental or psychiatric disorders
- Patients with history of drug abuse, high intracranial tension and history of MVD, SGK, balloon compression, RF treatment, or glycerol injection
- The possibility of vascular loop compression and other causes of TN
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 |
|---|---|---|
| combined conventional and pulsed radiofrequency (CCPRF)Patients with trigeminal neuralgia who underwent combined conventional and pulsed radiofrequency (CCPRF) for treatment of pain. | Procedure or surgery | combined conventional and pulsed radiofrequency of trigeminal nerve nucleus |
Primary outcome
Motor index
Time frame: 2 weeks
Change of the visual analogue scale score, from 0 to 100 , where 100 means worst pain
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 8 Nov 2021.
- efficacy of Pulsed Radiofrequency Stimulation in Patients with Peripheral Neuropathic Pain: A Narrative ReviewLink provided by the sponsor.
- Individual participant dataSharing planned: No. contacts personal details are not planned to be shared but the results can be shared after publication
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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.
Ehab H Shaker principal investigator
National Cancer Institute (NCI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined conventional and pulsed radiofrequency (CCPRF) in people with Pain, Chronic, run by National Cancer Institute, Egypt 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 3 inclusion and 3 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 8 Nov 2021. 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?
Motor index (time frame: 2 weeks). 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 8 Nov 2021.