Trigeminal NeuralgiaNCT02427074
Comparison Between Radiofrequency and Balloon Compression in the Treatment of Idiopathic Trigeminal Neuralgia
A study testing Balloon Compression Rhizotomy and Radiofrequency Thermal Coagulation Rhizotomy in people with Trigeminal Neuralgia, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Two percutaneous procedures used in the treatment of idiopathic trigeminal neuralgia are analysed. The effects on pain relief, alterations in cutaneous sensibility and olfactory and salivatory functions are analysed as well. 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?
- Balloon Compression Rhizotomy and Radiofrequency Thermal Coagulation Rhizotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2014to 30 Aug 2019
- 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
- Idiopathic Trigeminal Neuralgia
- Refractory/Intolerable medical treatment
- Pain restricted to second or third trigeminal division
Who cannot join
- Secondary Trigeminal Neuralgia
- Pain restricted to the first trigeminal division
- Refuse to participate
- Unable to comprehend the questionnaires
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Radiofrequency and Balloon Compression of the Gasserian Ganglion in the Treatment of Idiopathic Trigeminal Neuralgia
Two percutaneous procedures used in the treatment of idiopathic trigeminal neuralgia are analysed. The effects on pain relief, alterations in cutaneous sensibility and olfactory and salivatory functions are analysed as well.
Read the detailed description
Patients diagnosed with idiopathic trigeminal neuralgia, refractory or intolerant to medical treatment, are randomly assigned (after signing a consent form), to receive one of two percutaneous procedures. The patients are evaluated a week before and a week, a month, two months, three months and six months after the surgery.
The questionnaires (Short-Form of the McGill Pain Questionnaire - SF-MPQ, Douleur Neuropathique - DN4, Neuropathic Pain Symptom Inventory - NPSI, Brief Pain Inventory - BPI, Global Clinical Impression - GCI, Hospital Anxiety and Depression - HAD, Brief World Health Organization Quality of Life Questionnaire - WHOQOL-brief, Pain Catastrophizing Scale - PCS) and tests (Quantitative Sensory Testing - QST, olfactory threshold - OT - and discrimination - OD, taste threshold - TT, and salivatory quantification - SQ) are applied as follows:
- Pre-op evaluation: SF-MPQ, DN4, BPI, NPSI, HAD, WHOQOL-brief, PCS, QST, OT, OD, TT, SQ.
- First visit post-op: SF-MPQ, BPI, NPSI, GCI
- Second visit post-op: SF-MPQ, BPI, NPSI, GCI
- Third visit post-op: SF-MPQ, BPI, NPSI, GCI
- Fourth visit post-op: SF-MPQ, DN4, BPI, NPSI, GCI, WHOQOL-brief, HAD, PCS, QST, OT, TT, SQ.
- Fifth visit post-op: SF-MPQ, DN4, BPI, NPSI, GCI, WHOQOL-brief, HAD, PCS, QST, OT, OD, TT, SQ.
Patients with pain recurrence are excluded after the last visit attended. An exploratory analysis is made with 30 patients for a proper sample size calculation during the study.
- Conditions
- Trigeminal Neuralgia
- Being tested
- Balloon Compression Rhizotomy, Radiofrequency Thermal Coagulation Rhizotomy
- Medical subject headings
- Trigeminal Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon Compression RhizotomyProcedure or surgery
The balloon compression rhizotomy is performed in a percutaneous fashion where a Fogarty catheter is positioned in the gasserian ganglion and inflated with 0,7 milliliters of radiopaque dye during 120 seconds.
Radiofrequency Thermal Coagulation RhizotomyProcedure or surgery
The gasserian ganglion is submitted to a controlled thermal coagulation with a electrode with 80 Celsius degrees of temperature during 60 seconds on the specific division.
| Study group | Role | What they receive |
|---|---|---|
| Balloon Compression Rhizotomy | Active comparator | Patients that are submitted to Balloon Compression Rhizotomy Receives: Procedure: Balloon Compression Rhizotomy |
| Radiofrequency Thermal Coagulation Rhizotomy | Active comparator | Patients that are submitted to Radiofrequency Thermal Coagulation Rhizotomy Receives: Procedure: Radiofrequency Thermal Coagulation Rhizotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief using numeric rating scale
Worst pain in the last 24h scale in the Brief Pain Inventory
Measured: 6 months
Secondary outcomes (13)
Changes in how the pain is perceived by the patient assessed by the Short-Form of the McGill Pain Questionnaire
Short-Form of the McGill Pain Questionnaire
Measured: 6 months
Changes in neuropathic pain quality assessed by Douleur Neuropatique 4
Douleur Neuropatique 4
Measured: 6 months
Evaluation of chronic pain and its influence in patients life assessed by Brief Pain Inventory
Brief Pain Inventory
Measured: 6 months
Changes in types of symptoms of neuropathic pain assessed by Neuropathic Pain Symptom Inventory
Neuropathic Pain Symptom Inventory
Measured: 6 months
Changes in quality of life assessed by World Health Organization Quality of Life - brief form
World Health Organization Quality of Life - brief form
Measured: 6 months
Both patient and investigator impression in the treatment assessed by Global Clinical Impression
Global Clinical Impression
Measured: 6 months
Evaluation of how pain affects patients perception assessed by Pain Catastrophizing Scale
Pain Catastrophizing Scale
Measured: 6 months
Onset of changes in anxiety or depression assessed by Hospital Anxiety and Depression
Hospital Anxiety and Depression
Measured: 6 months
Quantification of facial sensibility changes assessed by Quantitative Sensorial Testing
Quantitative Sensorial Testing
Measured: 6 months
Changes in olfactory threshold assessed by isopropanol solution
Olfactory Threshold using isopropanol solution
Measured: 6 months
Changes in gustatory threshold assessed using sweet, sour, salty and bitter solutions
Gustatory Threshold using sweet, sour, salty and bitter solutions
Measured: 6 months
Changes in salivary flow assessed using cotton weights
Evaluation of salivary flow using cotton weights
Measured: 6 months
Changes in olfactory discrimination assessed using Sniffin' Sticks
Using Sniffin' Sticks to evaluate olfactory discrimination
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study start1 Feb 2014
- Primary completion31 Mar 2019
- Study completion30 Aug 2019
Why it stopped: Study halted due to futility
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 University of Sao PauloThe 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
- Participant, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hugo Sterman Neto, University of Sao Paulo
- Investigators
- Daniel Ciampi, MD, PhD, Study chair, HCFMSUP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427074
- Sponsor's protocol ID
- 1180/09
- Status last verified
- Feb 2020
- First submitted
- 18 Apr 2015
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Radiofrequency and Balloon Compression of the Gasserian Ganglion in the Treatment of Idiopathic Trigeminal Neuralgia
- ClinicalTrials.gov ID
- NCT02427074
- Acronym / sponsor ID
- 1180/09
- Conditions
- Trigeminal Neuralgia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study halted due to futility
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 1 Feb 2014 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 27 Apr 2015 (estimated)
- 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.
Two percutaneous procedures used in the treatment of idiopathic trigeminal neuralgia are analysed. The effects on pain relief, alterations in cutaneous sensibility and olfactory and salivatory functions are analysed as well.
Detailed description
Patients diagnosed with idiopathic trigeminal neuralgia, refractory or intolerant to medical treatment, are randomly assigned (after signing a consent form), to receive one of two percutaneous procedures. The patients are evaluated a week before and a week, a month, two months, three months and six months after the surgery.
The questionnaires (Short-Form of the McGill Pain Questionnaire - SF-MPQ, Douleur Neuropathique - DN4, Neuropathic Pain Symptom Inventory - NPSI, Brief Pain Inventory - BPI, Global Clinical Impression - GCI, Hospital Anxiety and Depression - HAD, Brief World Health Organization Quality of Life Questionnaire - WHOQOL-brief, Pain Catastrophizing Scale - PCS) and tests (Quantitative Sensory Testing - QST, olfactory threshold - OT - and discrimination - OD, taste threshold - TT, and salivatory quantification - SQ) are applied as follows:
- Pre-op evaluation: SF-MPQ, DN4, BPI, NPSI, HAD, WHOQOL-brief, PCS, QST, OT, OD, TT, SQ.
- First visit post-op: SF-MPQ, BPI, NPSI, GCI
- Second visit post-op: SF-MPQ, BPI, NPSI, GCI
- Third visit post-op: SF-MPQ, BPI, NPSI, GCI
- Fourth visit post-op: SF-MPQ, DN4, BPI, NPSI, GCI, WHOQOL-brief, HAD, PCS, QST, OT, TT, SQ.
- Fifth visit post-op: SF-MPQ, DN4, BPI, NPSI, GCI, WHOQOL-brief, HAD, PCS, QST, OT, OD, TT, SQ.
Patients with pain recurrence are excluded after the last visit attended. An exploratory analysis is made with 30 patients for a proper sample size calculation during the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balloon Compression Rhizotomy | Active comparator | Procedure: Balloon Compression RhizotomyPatients that are submitted to Balloon Compression Rhizotomy |
| Radiofrequency Thermal Coagulation Rhizotomy | Active comparator | Procedure: Radiofrequency Thermal Coagulation RhizotomyPatients that are submitted to Radiofrequency Thermal Coagulation Rhizotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Idiopathic Trigeminal Neuralgia
- Refractory/Intolerable medical treatment
- Pain restricted to second or third trigeminal division
Key exclusion criteria (4 listed)
- Secondary Trigeminal Neuralgia
- Pain restricted to the first trigeminal division
- Refuse to participate
- Unable to comprehend the questionnaires
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 |
|---|---|---|
| Balloon Compression RhizotomyThe balloon compression rhizotomy is performed in a percutaneous fashion where a Fogarty catheter is positioned in the gasserian ganglion and inflated with 0,7 milliliters of radiopaque dye during 120 seconds. | Procedure or surgery | Balloon Compression Rhizotomy |
| Radiofrequency Thermal Coagulation RhizotomyThe gasserian ganglion is submitted to a controlled thermal coagulation with a electrode with 80 Celsius degrees of temperature during 60 seconds on the specific division. | Procedure or surgery | Radiofrequency Thermal Coagulation Rhizotomy |
Primary outcome
Pain relief using numeric rating scale
Time frame: 6 months
Worst pain in the last 24h scale in the Brief Pain Inventory
13 secondary outcomes
Changes in how the pain is perceived by the patient assessed by the Short-Form of the McGill Pain Questionnaire
Time frame: 6 months
Changes in neuropathic pain quality assessed by Douleur Neuropatique 4
Time frame: 6 months
Evaluation of chronic pain and its influence in patients life assessed by Brief Pain Inventory
Time frame: 6 months
Changes in types of symptoms of neuropathic pain assessed by Neuropathic Pain Symptom Inventory
Time frame: 6 months
Changes in quality of life assessed by World Health Organization Quality of Life - brief form
Time frame: 6 months
Both patient and investigator impression in the treatment assessed by Global Clinical Impression
Time frame: 6 months
Evaluation of how pain affects patients perception assessed by Pain Catastrophizing Scale
Time frame: 6 months
Onset of changes in anxiety or depression assessed by Hospital Anxiety and Depression
Time frame: 6 months
Quantification of facial sensibility changes assessed by Quantitative Sensorial Testing
Time frame: 6 months
Changes in olfactory threshold assessed by isopropanol solution
Time frame: 6 months
Changes in gustatory threshold assessed using sweet, sour, salty and bitter solutions
Time frame: 6 months
Changes in salivary flow assessed using cotton weights
Time frame: 6 months
Changes in olfactory discrimination assessed using Sniffin' Sticks
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Study halted due to futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
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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.
Daniel Ciampi, MD, PhD study chair
HCFMSUP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Balloon Compression Rhizotomy and Radiofrequency Thermal Coagulation Rhizotomy in people with Trigeminal Neuralgia, run by University of Sao Paulo at 1 site in Brazil.
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 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: stopped early, as of the sponsor's last update on 13 Feb 2020. 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 Brazil. 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 was stopped early (reason given: Study halted due to futility). Results are not available in the source record.
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?
Pain relief using numeric rating scale (time frame: 6 months). 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 13 Feb 2020.