An interventional study of Pulsed radiofrequency (PRF) and thermocoagulation in Trigeminal Neuralgia, sponsored by Assiut University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-01-11.
Sponsored by Assiut University · Not applicable, Interventional, and Treatment
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.
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:-
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:-
Patient with severe, recurrent TN for more than 6 months, non-satisfactory pain relief with medical treatment or/and intolerable to medical drugs
Exclusion Criteria:
Known concurrent neurological or neurodegenerative diseases such as multiple sclerosis, and myasthenia gravis
received Pulsed radiofrequency (PRF) at 42°C for 8 minutes followed by CRF at 60°C for 270s
Device: Pulsed radiofrequency (PRF)
received sole thermocoagulation at 70°C for 270 s
Device: thermocoagulation
received PRF at 42°C for 8 minutes followed by CRF at 60°C for 270s
received sole CRF at 70°C for 270 s
Visual analog pain score
The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone
Time frame: one month
Visual analog pain score
The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone
Time frame: 6 months
Visual analog pain score
The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone
Time frame: one year
Visual analog pain score
The response for interventional treatment was evaluated in subsequent visits at pain clinic or by telephone
Time frame: 2 years
change in medical treatment
need for tricyclic antidepressant
Time frame: 2 years
Plan to share: Undecided
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Assiut University