Pulsed Radiofrequency in Trigeminal Neuralgia

NCT ID: NCT04355221

Last Updated: 2020-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-31
• Study Completion Date: 2019-07-31

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.

Conditions

Trigeminal Neuralgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group A

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).

Group Type: ACTIVE_COMPARATOR

pulsed radiofrequency

Intervention Type: PROCEDURE

Pulsed radiofrequency of the trigeminal nerve using NeuroTherm NT 1100 RF generator device

Group B

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.

Group Type: EXPERIMENTAL

pulsed radiofrequency

Intervention Type: PROCEDURE

Pulsed radiofrequency of the trigeminal nerve using NeuroTherm NT 1100 RF generator device

Group C

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.

Group Type: EXPERIMENTAL

pulsed radiofrequency

Intervention Type: PROCEDURE

Pulsed radiofrequency of the trigeminal nerve using NeuroTherm NT 1100 RF generator device

Interventions

pulsed radiofrequency

Pulsed radiofrequency of the trigeminal nerve using NeuroTherm NT 1100 RF generator device

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

MD/16.06.26

Identifier Type: -

Identifier Source: org_study_id