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
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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:-
140 studies on the registry are indexed under Trigeminal Neuralgia; 44 are open to participants now.
This study's enrollment of 40 is close to the median of 40 across 93 interventional studies indexed under Trigeminal Neuralgia.
Browse Trigeminal Neuralgia studies →Assiut University is the lead sponsor of 5,079 studies on the registry; 2,177 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Ran from Aug 2012 to primary completion in Jun 2017, 58 months.
Of 33 non-industry interventional studies with no phase under Trigeminal Neuralgia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 40. This study's 58 months is above that.
Counting every sponsor, half of 33 studies reached it within 27 months; a quarter within 11 and three quarters within 40.
How these figures are worked out, and which studies are left out of them.
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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