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Clinical randomized study to compare the clinical effectiveness between two modalities of treatment of trigeminal neuralgia namely gamma knife radio surgery and microvascular decompression
A randomized prospective study conducted in The Neurosciences Hospital, Baghdad, from January 2016 to January 2018, patients had either GKR treatment or treated with MVD. The pain evaluated pre- and post-operatively using the Barrow Neurological Institute Pain Intensity scale (BNIPI), visual analog scale (VAS) and Brief Pain Inventory Facial (BPI-Facial) scoring systems. In GKR procedure, the trigeminal root entry zone targeted with a radiation dose of 80 Gy. MVD was performed using retro-sigmoid approach. Follow-up period for two years
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gamma knife group | Active Comparator | Patients selected to be treated with gamma knife radiosurgery |
|
| MVD Group | Active Comparator | Patients treated with microvascular decompression |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamma knife | Radiation | Microvascular decompression |
|
| Measure | Description | Time Frame |
|---|---|---|
| Barrow Neurological Institute Pain Intensity scale (1-5) | The pain evaluated pre- and post-operatively with the use of analgesic drugs the best is 1 indicates free of pain, the worst is 5. It is dependent score | Two years |
| visual analog scale (0-10) | Pain severity described subjectively by the patient himself pre and post treatment , the 0 is free of pain and worst is 10. It is dependent score | Two years |
| Brief Pain Inventory (1-7) | Assess pain severity as impact to functional activities, the 7 is normal live activity and the worst is 1. It is dependent score | ُTwo years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Moneer K. Faraj, Facs | Neurosciences hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D014277 | Trigeminal Neuralgia |
| ID | Term |
|---|---|
| D020433 | Trigeminal Nerve Diseases |
| D005156 | Facial Neuralgia |
| D005155 | Facial Nerve Diseases |
| D009059 | Mouth Diseases |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| D013514 | Surgical Procedures, Operative |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| D009057 |
| Stomatognathic Diseases |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D008919 |
| Investigative Techniques |