Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:-
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PCRF group | Experimental | received Pulsed radiofrequency (PRF) at 42°C for 8 minutes followed by CRF at 60°C for 270s |
|
| CRF group | Experimental | received sole thermocoagulation at 70°C for 270 s |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulsed radiofrequency (PRF) | Device | received PRF at 42°C for 8 minutes followed by CRF at 60°C for 270s |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| change in medical treatment | need for tricyclic antidepressant | 2 years |
Not provided
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
Exclusion Criteria:
• Known concurrent neurological or neurodegenerative diseases such as multiple sclerosis, and myasthenia gravis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Abdelrady S Ibrahim, M.D. | Assiut university faculty of medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university faculty of medicine | Asyut | 7111 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11803301 | Background | Elias WJ, Burchiel KJ. Microvascular decompression. Clin J Pain. 2002 Jan-Feb;18(1):35-41. doi: 10.1097/00002508-200201000-00006. | |
| 31571339 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D061208 | Pulsed Radiofrequency Treatment |
| D004564 | Electrocoagulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D000078702 | Radiofrequency Therapy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| thermocoagulation | Device | received sole CRF at 70°C for 270 s |
|
| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D012046 | Rehabilitation |
| D002425 | Cautery |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |