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Comparison Between Radiofrequency and Balloon Compression in the Treatment of Idiopathic Trigeminal Neuralgia

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ClinicalTrials.gov Identifier: NCT02427074
Recruitment Status : Active, not recruiting
First Posted : April 27, 2015
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Hugo Sterman Neto, University of Sao Paulo

Brief 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.

Condition or disease Intervention/treatment Phase
Trigeminal Neuralgia Procedure: Balloon Compression Rhizotomy Procedure: Radiofrequency Thermal Coagulation Rhizotomy Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparative Study Between Radiofrequency and Balloon Compression of the Gasserian Ganglion in the Treatment of Idiopathic Trigeminal Neuralgia
Study Start Date : February 2014
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Balloon Compression Rhizotomy
Patients that are submitted to Balloon Compression Rhizotomy
Procedure: Balloon Compression Rhizotomy
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.

Active Comparator: Radiofrequency Thermal Coagulation Rhizotomy
Patients that are submitted to Radiofrequency Thermal Coagulation Rhizotomy
Procedure: Radiofrequency Thermal Coagulation Rhizotomy
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.




Primary Outcome Measures :
  1. Pain relief using the visual analogic scale [ Time Frame: 6 months ]
    Average pain using the visual analogic scale in the Brief Pain Inventory


Secondary Outcome Measures :
  1. Changes in how the pain is perceived by the patient assessed by the Short-Form of the McGill Pain Questionnaire [ Time Frame: 6 months ]
    Short-Form of the McGill Pain Questionnaire

  2. Changes in neuropathic pain quality assessed by Douleur Neuropatique 4 [ Time Frame: 6 months ]
    Douleur Neuropatique 4

  3. Evaluation of chronic pain and its influence in patients life assessed by Brief Pain Inventory [ Time Frame: 6 months ]
    Brief Pain Inventory

  4. Changes in types of symptoms of neuropathic pain assessed by Neuropathic Pain Symptom Inventory [ Time Frame: 6 months ]
    Neuropathic Pain Symptom Inventory

  5. Changes in quality of life assessed by World Health Organization Quality of Life - brief form [ Time Frame: 6 months ]
    World Health Organization Quality of Life - brief form

  6. Both patient and investigator impression in the treatment assessed by Global Clinical Impression [ Time Frame: 6 months ]
    Global Clinical Impression

  7. Evaluation of how pain affects patients perception assessed by Pain Catastrophizing Scale [ Time Frame: 6 months ]
    Pain Catastrophizing Scale

  8. Onset of changes in anxiety or depression assessed by Hospital Anxiety and Depression [ Time Frame: 6 months ]
    Hospital Anxiety and Depression

  9. Quantification of facial sensibility changes assessed by Quantitative Sensorial Testing [ Time Frame: 6 months ]
    Quantitative Sensorial Testing

  10. Changes in olfactory threshold assessed by isopropanol solution [ Time Frame: 6 months ]
    Olfactory Threshold using isopropanol solution

  11. Changes in gustatory threshold assessed using sweet, sour, salty and bitter solutions [ Time Frame: 6 months ]
    Gustatory Threshold using sweet, sour, salty and bitter solutions

  12. Changes in salivary flow assessed using cotton weights [ Time Frame: 6 months ]
    Evaluation of salivary flow using cotton weights

  13. Changes in olfactory discrimination assessed using Sniffin' Sticks [ Time Frame: 6 months ]
    Using Sniffin' Sticks to evaluate olfactory discrimination



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Idiopathic Trigeminal Neuralgia
  • Refractory/Intolerable medical treatment
  • Pain restricted to second or third trigeminal division

Exclusion Criteria:

  • Secondary Trigeminal Neuralgia
  • Pain restricted to the first trigeminal division
  • Refuse to participate
  • Unable to comprehend the questionnaires

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02427074


Locations
Brazil
HCFMSUP
São Paulo, SP, Brazil, 05403000
Sponsors and Collaborators
University of Sao Paulo
Investigators
Study Chair: Daniel Ciampi, MD, PhD HCFMSUP

Responsible Party: Hugo Sterman Neto, medical doctor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02427074     History of Changes
Other Study ID Numbers: 1180/09
First Posted: April 27, 2015    Key Record Dates
Last Update Posted: October 11, 2018
Last Verified: October 2018

Additional relevant MeSH terms:
Neuralgia
Trigeminal Neuralgia
Trigeminal Nerve Diseases
Facial Neuralgia
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms
Facial Nerve Diseases
Mouth Diseases
Stomatognathic Diseases
Cranial Nerve Diseases