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Completed

NCT Number: NCT04864964

the Value of Sensory Index in Trigeminal Neuralgia

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Institute

Cairo, 11796, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

combined conventional and pulsed radiofrequency (CCPRF)

Procedure

Patients with trigeminal neuralgia who underwent combined conventional and pulsed radiofrequency (CCPRF) for treatment of pain.

Primary outcomes

  1. Motor index

    Time frame: 2 weeks

    Change of the visual analogue scale score, from 0 to 100 , where 100 means worst pain

Sponsors and collaborators

Lead sponsor

National Cancer Institute, Egypt

Other

Registry information

Official study title

The Value of Sensory Index in Predicting the Success of Radiofrequency Treatment of Trigeminal Neuralgia: A Retrospective Study

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Apr 29, 2021
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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