the Value of Sensory Index in Trigeminal Neuralgia

NCT04864964 | Completed

• 1 other identifier: Ehab-Hossam trigeminal
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pain, Chronic

Outcome Measures

Primary Outcomes (1)

• Motor index

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

  2 weeks

Study Arms (1)

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 .

Procedure: combined conventional and pulsed radiofrequency (CCPRF)

Interventions

combined conventional and pulsed radiofrequency (CCPRF) PROCEDURE

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

combined conventional and pulsed radiofrequency of trigeminal nerve nucleus

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, 11796, Egypt

Location

Related Links

• efficacy of Pulsed Radiofrequency Stimulation in Patients with Peripheral Neuropathic Pain: A Narrative Review

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ehab H Shaker

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesia, intensive care and Pain releif

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: April 29, 2021
• Study Start: May 1, 2014
• Primary Completion: October 28, 2019
• Study Completion: July 15, 2020
• Last Updated: November 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)