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

Not Applicable

Completed

• Conditions: Trigeminal Neuralgia
• Interventions: Device: thermocoagulation; Device: Pulsed radiofrequency (PRF)

• Registration Number: NCT03396406
• Lead Sponsor: Assiut University

Brief 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.

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 Timeline

• Study Start: 2012-08
• Primary Completion: 2017-06
• Study Completion: 2017-09
• Status Verified: 2018-01
• Study First Submitted: 2018-01-04
• Study First Submitted QC: 2018-01-09
• Last Update Submitted: 2018-01-09
• Study First Posted: 2018-01-11
• Last Update Posted: 2018-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CRF group	thermocoagulation	received sole thermocoagulation at 70°C for 270 s
PCRF group	Pulsed radiofrequency (PRF)	received Pulsed radiofrequency (PRF) at 42°C for 8 minutes followed by CRF at 60°C for 270s

Primary Outcome Measures

Name	Time	Method
Visual analog pain score	2 years	The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone

Secondary Outcome Measures

Name	Time	Method
change in medical treatment	2 years	need for tricyclic antidepressant

Trial Locations

Locations (1)

Assiut university faculty of medicine; 🇪🇬 Assiut, Egypt