Pulsed Radiofrequency in Trigeminal Neuralgia

NCT04355221 | Completed

• 1 other identifier: MD/16.06.26
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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

Keywords

pulsed radiofrequency

Outcome Measures

Primary Outcomes (1)

• Pain amplitude reduction

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

  1 year

Secondary Outcomes (1)

• RAND 36-Item Health Survey

  1 year

Study Arms (3)

Group A

ACTIVE COMPARATOR

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).

Procedure: pulsed radiofrequency

Group B

EXPERIMENTAL

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.

Procedure: pulsed radiofrequency

Group C

EXPERIMENTAL

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.

Procedure: pulsed radiofrequency

Interventions

pulsed radiofrequency PROCEDURE

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

Group A; Group B; Group C

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

MeSH Terms

Conditions

Trigeminal Neuralgia

Interventions

Pulsed Radiofrequency Treatment

Condition Hierarchy (Ancestors)

Trigeminal Nerve Diseases; Facial Neuralgia; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Radiofrequency Therapy; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2019
• First Posted: April 21, 2020
• Study Start: July 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: April 21, 2020

Record last verified: 2020-04