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

Trigeminal Neuralgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03396406
• Other study ID #: IRB0000871244
• Status: Completed
• Phase: N/A
• First received: January 4, 2018
• Last updated: January 9, 2018
• Start date: August 2012
• Est. completion date: September 2017

Study information

• Verified date: January 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neuralgia
• Trigeminal Neuralgia

Intervention

Device:
• Pulsed radiofrequency (PRF)
received PRF at 42°C for 8 minutes followed by CRF at 60°C for 270s
• thermocoagulation
received sole CRF at 70°C for 270 s

Locations

Country	Name	City	State
Egypt	Assiut university faculty of medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

Elias WJ, Burchiel KJ. Microvascular decompression. Clin J Pain. 2002 Jan-Feb;18(1):35-41. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog pain score	The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone	one month
Primary	Visual analog pain score	The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone	6 months
Primary	Visual analog pain score	The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone	one year
Primary	Visual analog pain score	The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone	2 years
Secondary	change in medical treatment	need for tricyclic antidepressant	2 years