Evaluating the Sensory Index for Success of Trigeminal RF

NCT05748132 | Completed

• 1 other identifier: sensory index in RF
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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 trigeminal nerve and preservation of its regular function. The most common procedures in treating TN pain are the use of radiofrequency (RF).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 .

Conditions

Radiotherapy; Complications

Outcome Measures

Primary Outcomes (1)

• Sensory index effectiveness

  The relation between the sensory index and the success of the procedure defined as reduction of the Visual analogue score by 50% or more.

  3 years

Secondary Outcomes (2)

• Number of recurrence

  3 years

• Assessment of quality of life

  3 Years

Study Arms (1)

trigeminal Radiofrequency

EXPERIMENTAL

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.

Procedure: combined conventional and pulsed RF

Interventions

combined conventional and pulsed RF PROCEDURE

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

trigeminal Radiofrequency

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 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)

Ehab Hanafy Shaker

Cairo, 12588, Egypt

Location

Related Publications (1)

• Ding Y, Li H, Hong T, Zhu Y, Yao P, Zhou G. Combination of Pulsed Radiofrequency with Continuous Radiofrequency Thermocoagulation at Low Temperature Improves Efficacy and Safety in V2/V3 Primary Trigeminal Neuralgia. Pain Physician. 2018 Sep;21(5):E545-E553.

  PMID: 30282402 RESULT

Study Officials

• Ehab H Shaker, MD

  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, ICU and Pain management

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 28, 2023
• Study Start: January 1, 2014
• Primary Completion: February 28, 2019
• Study Completion: March 30, 2021
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)