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Pulsed Radiofrequency in Trigeminal Neuralgia

Primary Purpose

Trigeminal Neuralgia

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
pulsed radiofrequency
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Trigeminal Neuralgia focused on measuring pulsed radiofrequency

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients are diagnosed as classic TN according to the international headache society classification of headache disorders
  • Visual analogue scale (VAS) for pain of at least 4 or more.
  • Pain is refractory to medical treatment (for at least 3 months with three drugs including carbamazepine with optimum dosage) or patients who developed intolerable side effects from medications.

Exclusion Criteria:

  • Symptomatic (secondary) TN: which is causes by structural lesion other than neurovascular compression such as multiple sclerosis, tumors, stroke or trauma according to the international headache society classification (IHS, 2013).

Local infection at the site of the needle puncture. Bleeding tendency or coagulopathy. Previous treatment with invasive treatments such as radiofrequency thermo coagulation, destructive chemical injection, gamma knife treatment, percutaneous balloon micro-compression or microvascular decompression.

Major mental or psychiatric disorders. History of drug abuse.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Experimental

    Arm Label

    Group A

    Group B

    Group C

    Arm Description

    using the standard settings of pulsed radiofrequency technique (PRFT). two cycles, each one for 2 minutes at 45 Volts (V) with a pulse width of 10 milliseconds (ms) and a pulse frequency of 4 Hertz (Hz). The cut-off needle tip temperature is set at 420 Celsius (C).

    using prolonged duration of PRFT. four cycles, each one for 2 minutes at 45V with a pulse width of 10ms and a pulse frequency of 4Hz. The cut-off needle tip temperature is set at 420C.

    using higher voltage PRFT.. two cycles, each one for 2 minutes at 60V with a pulse width of 10ms and a pulse frequency of 4Hz. The cut-off needle tip temperature is set at 420C.

    Outcomes

    Primary Outcome Measures

    Pain amplitude reduction
    compare the pain amplitude reduction in the three groups using the visual analogue pain scale

    Secondary Outcome Measures

    RAND 36-Item Health Survey
    compare the quality of life changes before and after intervention using RAND 36-Item Health Survey

    Full Information

    First Posted
    December 1, 2019
    Last Updated
    April 17, 2020
    Sponsor
    Mansoura University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04355221
    Brief Title
    Pulsed Radiofrequency in Trigeminal Neuralgia
    Official Title
    Pulsed Radiofrequency in Treatment of Classic Trigeminal Neuralgia (Prolonged Duration Versus Higher Voltage)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2016 (Actual)
    Primary Completion Date
    July 2019 (Actual)
    Study Completion Date
    July 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mansoura University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The current study investigated the efficacy of pulsed radiofrequency in pain reduction in TN patients and compared the efficacy and the impact on the quality of life of the standard technique with a prolonged duration technique and a higher voltage one. Entire enrolled patients were diagnosed as classic TN according to the international headache society classification (IHS, 2013) and underwent brain MRI and MRA to exclude secondary causes. Patients were randomly divided into three groups, Group A patients underwent PRF using the standard settings, group B patients underwent PRF with prolonged duration and Group C patients underwent PRF with higher voltage. VAS and pain amplitude reduction were recorded before the intervention and 1 hour, 1 day, 1week, 1 month, 6 months and 1year after it. Quality of life was assessed before and 1 year after the intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Trigeminal Neuralgia
    Keywords
    pulsed radiofrequency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A
    Arm Type
    Active Comparator
    Arm Description
    using the standard settings of pulsed radiofrequency technique (PRFT). two cycles, each one for 2 minutes at 45 Volts (V) with a pulse width of 10 milliseconds (ms) and a pulse frequency of 4 Hertz (Hz). The cut-off needle tip temperature is set at 420 Celsius (C).
    Arm Title
    Group B
    Arm Type
    Experimental
    Arm Description
    using prolonged duration of PRFT. four cycles, each one for 2 minutes at 45V with a pulse width of 10ms and a pulse frequency of 4Hz. The cut-off needle tip temperature is set at 420C.
    Arm Title
    Group C
    Arm Type
    Experimental
    Arm Description
    using higher voltage PRFT.. two cycles, each one for 2 minutes at 60V with a pulse width of 10ms and a pulse frequency of 4Hz. The cut-off needle tip temperature is set at 420C.
    Intervention Type
    Procedure
    Intervention Name(s)
    pulsed radiofrequency
    Intervention Description
    Pulsed radiofrequency of the trigeminal nerve using NeuroTherm NT 1100 RF generator device
    Primary Outcome Measure Information:
    Title
    Pain amplitude reduction
    Description
    compare the pain amplitude reduction in the three groups using the visual analogue pain scale
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    RAND 36-Item Health Survey
    Description
    compare the quality of life changes before and after intervention using RAND 36-Item Health Survey
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients are diagnosed as classic TN according to the international headache society classification of headache disorders Visual analogue scale (VAS) for pain of at least 4 or more. Pain is refractory to medical treatment (for at least 3 months with three drugs including carbamazepine with optimum dosage) or patients who developed intolerable side effects from medications. Exclusion Criteria: Symptomatic (secondary) TN: which is causes by structural lesion other than neurovascular compression such as multiple sclerosis, tumors, stroke or trauma according to the international headache society classification (IHS, 2013). Local infection at the site of the needle puncture. Bleeding tendency or coagulopathy. Previous treatment with invasive treatments such as radiofrequency thermo coagulation, destructive chemical injection, gamma knife treatment, percutaneous balloon micro-compression or microvascular decompression. Major mental or psychiatric disorders. History of drug abuse.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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