Treatment of Recurrent Trigeminal Neuralgia by Using Extended Duration of Pulsed Radiofrequency

Comparison of Extended Duration Pulsed Radiofrequency Plus Low Temperature Thermal Radiofrequency With Thermal Radiofrequency Alone in Treatment of Recurrent Trigeminal Neuralgia

Forty patients with history of recurrent TN were recruited in Assiut University Hospitals, Pain Unit from 2012 to 2017. Before the study, all patients were given adequate and informative data about the nature of the study, interventional procedure and its possible complications, and a well-informed written consent was obtained from each patients.

Study Overview

• Status: Completed
• Conditions: Trigeminal Neuralgia
• Intervention / Treatment: Device: Pulsed radiofrequency (PRF); Device: thermocoagulation

Detailed Description

All interventions were done in a specialized well-equipped unit at Assiut University hospital and continuous hemodynamic monitoring with pulse oximetry, blood pressure and ECG applied for each patient. Light sedation by using midazolam 5mg bolus. In a supine position with slightly extended head and under fluoroscopic control, C arm rotated caudo-cranially and ipsilateraly to produce an oblique submental view and visualize foramen ovale beside the ramus of the mandible. The point of entry varied according to the affected branch, but it ranged from 0.5-1.5 cm from the corner of the mouth. The point of entry cleaned by aseptic solution and anaesthetized with 1% of Lidocaine. C arm has been rotated laterally to confirm the depth of penetration once the needle entered into Meckel's cavity. RF electrode (22-G, 10 cm needle, with a curved 5 mm active tip, Neurotherm 1100) was used and the exact position of the needle confirmed by sensory stimulation, motor stimulation and negative aspiration as the following criteria:-

1. Sensory stimulation (50 Hz) threshold between 0.1-0.3 V which made paresthesia and/ or tingling in the affected painful area. Patient was awake to respond to the sensory stimulation
2. Motor stimulation at 2Hz with 0.1-1.5V caused muscle contraction of the lower mandible.

After confirming the position of the RF electrode, each patient received 0.5 ml of 1% of Lidocaine to avoid discomfort during treatment. Then the type of intervention determined by the person who was responsible for randomisation process and who did not involve in assessing eligibility or interventional technique and divided into:-

• Group A: pulsed radiofrequency was applied for 4 cycles of 120 seconds ( 8 minutes in total) at 45 V and temperature was set at 42 C. then conventional radiofrequency thermal lesion was applied for 3 cycles of 90 seconds at 60 c.
• Group B: thermal energy was applied gradually for 3 cycles of 90 seconds at 70 C.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 7111
    • Assiut University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• • Patient with severe, recurrent TN for more than 6 months, non-satisfactory pain relief with medical treatment or/and intolerable to medical drugs

  • Age more than 18 years old
  • Pain score ≥ 7
  • Patient consent to participate

Exclusion Criteria:

• • Known concurrent neurological or neurodegenerative diseases such as multiple sclerosis, and myasthenia gravis

  • Breast feeding or pregnant women
  • Advanced malignancy or brain stem tumors
  • Coagulopathy or patients on anticoagulant medications
  • Allergy/ sensitivity to Lidocaine anesthetic or/and non- ionic contrast media
  • Presence of Progressive Motor or sensory deficit in the distribution of trigeminal nerve
  • Active psychological or mental diseases
  • Uncontrolled medical or respiratory conditions
  • Patients who are unwilling to participate

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PCRF group; received Pulsed radiofrequency (PRF) at 42°C for 8 minutes followed by CRF at 60°C for 270s	Device: Pulsed radiofrequency (PRF); received PRF at 42°C for 8 minutes followed by CRF at 60°C for 270s
Experimental: CRF group; received sole thermocoagulation at 70°C for 270 s	Device: thermocoagulation; received sole CRF at 70°C for 270 s

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analog pain score	The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone	one month
Visual analog pain score	The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone	6 months
Visual analog pain score	The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone	one year
Visual analog pain score	The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
change in medical treatment	need for tricyclic antidepressant	2 years

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Elias WJ, Burchiel KJ. Microvascular decompression. Clin J Pain. 2002 Jan-Feb;18(1):35-41. doi: 10.1097/00002508-200201000-00006.
• Abdel-Rahman KA, Elawamy AM, Mostafa MF, Hasan WS, Herdan R, Osman NM, Ibrahim AS, Aly MG, Ali AS, Abodahab GM. Combined pulsed and thermal radiofrequency versus thermal radiofrequency alone in the treatment of recurrent trigeminal neuralgia after microvascular decompression: A double blinded comparative study. Eur J Pain. 2020 Feb;24(2):338-345. doi: 10.1002/ejp.1489. Epub 2019 Oct 16.

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2012
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: January 4, 2018
• First Submitted That Met QC Criteria: January 9, 2018
• First Posted (Actual): January 11, 2018

Study Record Updates

• Last Update Posted (Actual): January 11, 2018
• Last Update Submitted That Met QC Criteria: January 9, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: trigeminal neuralgia, radiofrequency
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Stomatognathic Diseases; Mouth Diseases; Peripheral Nervous System Diseases; Cranial Nerve Diseases; Facial Nerve Diseases; Trigeminal Nerve Diseases; Facial Neuralgia; Neuralgia; Trigeminal Neuralgia
• Other Study ID Numbers: IRB0000871244

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No