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Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve Neuroablation: Radiofrequency (RF) Neurotomy: Trigeminal Nerve Evidence of effectiveness 1 systematic review (1 included) ~ 10 comparative studies (1 included) ~/− − − − − − − 7 observational studies (3 included) 2 2 1.5 0.5 0.5 0.5 0 − − − Evidence of safety and harm 3 other reports 13 studies appraised as low quality (excluded above) Generic legend: n/a - not applicable n/s - not stated n/r - not relevant ? - unsure or unclear 1 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve Systematic Review study authors and year study inclusion & exclusion criteria exposure / comparison treatment (number of studies included) common outcomes among studies results validity / applicability yes no n/a n/s ? conclusions, comments and quality scores 15 specific quality criteria for reporting of other study information, studies scoring 10 or more were included. Other inclusions: Kaplan-Meier actuarial analysis for single procedure, not more than 20% loss to follow up, less than 10% of patients treated more than once and results analysed separately for each procedure, min 12 month median/mean follow up, min 30 patients in whole series, reporting of complete pain relief with/without medication. All ablative techniques for the treatment of trigeminal neuralgia: radiofrequency thermocoagulati on (RF) (n=4), glycerol rhizolysis (n=2), balloon microcompressi on (n=1), stereotactic radiosurgery (n=2). complete pain relief at 3 years, RF 61%, 62%, 58%, 64% focussed question yes thorough search strategy yes validity: + precision: ~ applicability: ~/− complete pain relief at 3 years, glycerol rhizolysis 54%, 53% search terms defined yes yes complete pain relief at 3 years, balloon microcompression 69% appropriate inclusion / exclusion criteria two reviewers - selection study validity rated yes two reviewers - validity yes valid combination of studies yes appropriate analysis yes all important outcomes considered balance between benefits and harms fair conclusions from evidence yes study design Lopez, B. C., Hamlyn, P. J., & Zakrzewska, J. M. (2004). Systematic review of ablative neurosurgical techniques for the treatment of trigeminal neuralgia. Neurosurgery, 54(4), 973-983. systematic review Included studies radiofrequency: Latchaw et al, 1983; Kanpolat, 2001; Oturai, 1996; Zakrzewska, 1999 glycerol rhizotomy: North, 1990; Slettebo, 1993 balloon microcompression: Brown, 1993 stereotactic radiosurgery: Maesawa, 2001; Pollock, 2002 yes no yes? overall quality: ~ authors’ conclusions: RF offers best pain relief, RCTs required, reporting should be improved. reviewer’s comments: strict validity criteria set down for these papers, so not many included. clear appreciation of differences between studies, so no actual combination of results performed. main concern is that these were all uncontrolled studies, so comparisons between interventions should be tentative. 2 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve Comparative Study study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (include adverse events) patients with facial pain: 181 with trigeminal neuralgia (TN), 31 with multiple sclerosis & TN, 25 with atypical facial pain, 4 with anaesthesia dolorosa (total 241) no details of reasons for allocation to each intervention thermo-coagulation: normally 3 lesions at 70°C for 60 seconds (133 operations) results therm GR micro idiopathic TN long term success, one Tx only 56/61 (92%) 29/36 (81%) 7/7 (100%) idiopathic TN long term success as 1st Tx 31 / 71 (44%) 25/32 (78%) 6/8 (75%) idiopathic TN long term success as subsequent Tx 30/62 (48%) 11/12 (92%) 1/1 (100%) multiple sclerosis TN long term success 8/18 (44%) 9/18 (50%) 4/4 (100%) multiple sclerosis TN long term success, one Tx only 5/18 (28%) 8/18 (44%) 4/4 (100%) validity / applicability yes no n/a n/s ? conclusions, comments, and quality scores randomised no method described n/a validity: − precision: ~ applicability: −/? similar at baseline n/s concealment n/a intention to treat n/a blinding appropriate no single blind no double blind no blind outcome assessment no compliance OK n/a follow-up OK yes? study design Braun, V., Nehls, B., Wellmann, A., Rath, S. A., Antoniadis, G., & Richter, H. P. (1996). Percutaneous treatment for trigeminal neuralgia Experience with 241 patients for 16 years. Neurology Psychiatry & Brain Research, 4(1), 37-43. historical control retrogasserian glycerol rhizolysis (44 ops) microcompression of gasserian ganglion, balloon filled with contrast medium, pressure kept constant for 1 minute. (9 ops) side effects hypaesthesia / hypalgesia 54 – 67% 23 – 33% 78 – 100% drop outs <20% yes hyp / anaesthesia dolorosa meningitis 1 – 11% 0 0 generalisability ? 0 2 – 11% 0 feasible / affordable ? herpes infection 0 5% 0 no atrophy of masseter muscle 0 0 25% all important outcomes considered balance between benefits and harms overall quality: ~/− authors’ conclusions: glycerol is Tx of choice, poor success with any Tx in patients with atypical face pain and anaesthesia dolorosa reviewer’s comments: useful presentation of results. overall study is messy though – variation in follow up duration, different conditions treated, multiple interventions. Direct comparison between results of each intervention is inappropriate no 3 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve Observational Studies study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (including adverse events) results validity / applicability patients with facial pain, evaluated by interview, history and physical examination. Trigeminal neuralgia diagnosed if: paroxysmal, lancinating, electric-like pain; tactile trigger areas; unilateral symptoms; restricted to the distribution of the trigeminal nerve and no neurosensory deficit. All patients had an MRI scan and were excluded if an abnormality was identified. People for whom medical therapy was not adequate or not well tolerated surgical treatment were considered for surgery = 39% of those evaluated. percutaneous RF thermal rhizotomy of Gasserian ganglion. Foramen ovale imaged with fluoroscopy, cannula inserted under general anaesthesia. Position confirmed by electrical stimulation in conscious patient. Lesion carried out in unconscious patient at 60°C for 60 secs (increased temperature may be required in repeat lesions if no appreciable analgesia is achieved). (n=258) excellent or good pain relief 0-6 months 0.870 excellent or good pain relief 12-80 months (mean 38)* 0.830 study design Mathews, E. S., & Scrivani, S. J. (2000). Percutaneous stereotactic radiofrequency thermal rhizotomy for the treatment of trigeminal neuralgia (erratum appears in Mt Sinai J Med. 2003 Jan 70 (1): 2). Mount Sinai Journal of Medicine, 67(4), 288-299. case series Scrivani, 1999 not fully appraised as it involves a smaller group of this same body of patients followed for a shorter time period side effects yes no n/a n/s ? conclusions, comments, and quality scores randomised no case series score: 2 / 3 method described n/a similar at baseline n/a concealment n/a intention to treat n/a authors’ conclusions: using specified diagnostic and management algorithm, RF treatment was effective with few side effects blinding appropriate n/a single blind n/a masticatory muscle weakness dysesthesia 28.8% double blind n/a 8% blind outcome assessment n/a anaesthesia dolorosa 2% compliance OK n/a corneal analgesia 3% follow-up OK yes? keratitis 0.8% drop outs <20% yes aseptic (chemical) meningitis 0.8% generalisability yes feasible / affordable ? all important outcomes considered balance between benefits and harms yes no significant morbidity or mortality reviewer’s comments: reasonable case series *this includes repeat procedures for 31 people and 37 people on medical therapy no 4 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (including adverse events) results validity / applicability yes no n/a n/s ? conclusions, comments, and quality scores consecutive patients treated by main author for trigeminal neuralgia with this technique percutaneous stereotactic radiofrequency rhizotomy: “all procedures used straight electrode and radiofrequency current” - no other details provided pain recurrence at 5 years (Kaplan-Meier estimates) 15% randomised no case series score: 2 / 3 method described n/a pain recurrence at 5-10 years (Kaplan-Meier estimates) 7% similar at baseline n/a concealment n/a pain recurrence at 10-15 years (Kaplan-Meier estimates) 3% intention to treat n/a blinding appropriate n/a authors’ conclusions: 99% of patients received immediate pain relief, which persisted for most people for several years. Level of facial numbness correlated with time to recurrence. (n=154, 100 followed up to 15 years) side effects facial numbness 66 (46%) analgesia 61 (42%) dense hypalgesia 17 (12%) mild hypalgesia single blind n/a double blind n/a dysaesthesia blind outcome assessment n/a compliance OK n/a follow-up OK yes drop outs <20% no* generalisability no keratitis 103 (77%) ‘not disturbing’ 20 (15%) ‘rare and a mild disturbance’ 7 (5%) ‘occasional and moderate disturbance’ 4 (3%) ‘frequent and severe disturbance’ 21 decreased 8 absent 3 trigeminal motor weakness 22 pterygoid or masseter (resolved in 12 months for 19 patients) study design Taha, J. M., Tew Jr, J. M., & Buncher, C. R. (1995). A prospective 15year follow up of 154 consecutive patients with trigeminal neuralgia treated by percutaneous stereotactic radiofrequency thermal rhizotomy. Journal of Neurosurgery., 83(6), 989-993. case series corneal reflex feasible / affordable ? all important outcomes considered balance between benefits and harms no reviewer’s comments: disappointing level of reporting on patient selection and technique. 35% loss to follow up at 15 years. no 5 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (including adverse events) patients with essential trigeminal neuralgia (TN), intolerant or intractable to medical therapy (carbamazepine, diphenylhydantoin), TN confirmed by CT scan (from 1976 onwards), MRI carried out if demyelinating disease suspected (after 1981). Percutaneous retrogasserian thermorhizotomy (technique (with minimal modification) as described by Sweet (’69)). Electrode placed under fluoroscopic control, and checked by motor/sensory stimulation, RF lesion carried out at 6570°C for 60 seconds, repeated until analgesia developed in the involved branch (n=1000) no recurrence of pain at 3 years results yes no n/a n/s ? validity / applicability study design Broggi, G., Franzini, A., Lasio, G., Giorgi, C., & Servello, D. (1990). Longterm results of percutaneous retrogasserian thermorhizotom y for 'essential' trigeminal neuralgia: Considerations in 1000 consecutive patients. Neurosurgery, 26(5), 783-786. case series 0.872 conclusions, comments, and quality scores randomised no case series score: 1.5 / 3 method described n/a similar at baseline n/a authors’ conclusions: successful pain relief in most patients, sensory deficits are to be expected as a side effect and risk explained to patient. no recurrence of pain at last follow up 0.829 concealment n/a side effects n (%) intention to treat n/a masseter weakness 105 (10.5) blinding appropriate n/a paresthesias requiring medical treatment 52 (5.2) single blind n/a double blind n/a painful anaesthesia 15 (1.5) blind outcome assessment n/a ocular palsies and diplopia 5 (0.5) compliance OK n/a corneal reflex impairment without keratitis 197 (19.7) follow-up OK yes drop outs <20% yes? corneal reflex impairment with keratitis 6 (0.6) generalisability yes? feasible / affordable ? vasomotor rhinorrhea 1 (0.1) no* mortality 0 all important outcomes considered balance between benefits and harms reviewer’s comments: as reasonable / useful as a retrospective case series can be. * optimal outcome of complete pain relief was only outcome ? 6 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve Other Reports (safety and harm) study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (including adverse events) results pure TN mix TN patients diagnosed with trigeminal neuralgia, no prior surgery, lack of tolerance or efficacy from drug treatment. RF thermocoagulation of the Gasserian ganglion, lesion produced at 7080°C for 300 seconds pain recurrence rate at 3 years (Kaplan-Meier) 0.387 0.352 mean time to recurrence (months) 40 study design Zakrzewska, J. M., Jassim, S., & Bulman, J. S. (1999). A prospective, longitudinal study on patients with trigeminal neuralgia who underwent radiofrequency thermocoagulati on of the Gasserian ganglion. Pain, 79(1), 51-58. Exclusions: poor command of english language (n= 31 pure trigeminal neuralgia, n=17 mixed trigeminal neuralgia / atypical facial pain) conclusions, comments, and quality scores means (precision) authors’ conclusions: pure TN patients were more satisfied with outcomes, had fewer complications, and more willing to have repeat surgery. Depression/anxiety reduced more in pure TN group 36 McGill Questionnaire (MGQ) present pain intensity MD 0.3 (95% CI -0.3 to 0.9) MGQ pain rating index MD -5.0 (95% CI 12.5 to 2.5) MGQ sensory MD -1.1 (95% CI -6.5 to 4.3) MGQ affective MD -4.6 (95% CI -6.2 to -3.0) case series n<50 side effects atypical face pain numbness 12% 71% p<0.001 32% 37% p<0.001? problems with eating 8% 25% p<0.01 eye problems 8% 25% p<0.001 reviewer’s comments: reasonable smallish study, also included Hospital Anxiety & Depression Scale (HAD) on partial follow up group 7 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (including adverse events) results patients with multiple sclerosis treated for symptomatic trigeminal neuralgia percutaneous controlled radiofrequency rhizotomy, foramen ovale punctured by electrode, position confirmed by x-ray and electrical stimulation in 14 patients. RF lesion applied at 60-70°C for 1 minute in conscious patients, average 5 lesions made per location complete pain relief after single procedure 0.706 complete pain relief (no medication required) (mean follow up 5 years) 0.824 partial pain relief (reduced medication required, 5 years) 0.164 overall recurrence (mean 25 months) 0.294 conclusions, comments, and quality scores study design Kanpolat, Y., Berk, C., Savas, A., & Bekar, A. (2000). Percutaneous controlled radiofrequency rhizotomy in the management of patients with trigeminal neuralgia due to multiple sclerosis. Acta Neurochirurgica , 142(6), 685689. retrospective case series n<50 (n=17) authors’ conclusions: all 17 patients classified as having achieved good results, no complications reviewer’s comments: retrospective analysis –hence risk of bias in results. Vague presentation of follow up figures to each time period – makes results less clear. side effects post operative hypalgesia & hypoesthesia n=13 dysesthesia 0 anaesthesia dolorosa 0 no other major complication / morbidity / mortality 8 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (including adverse events) results patients with typical trigeminal neuralgia (including 3 with multiple sclerosis, 1 with septum in foramen ovale, 1 with tuberculous meningitis) – all but 2 patients had a range of prior treatments / medications. modified Sweet & Wepsic technique. local anaesthetic used, then electrode advanced towards foramen ovale, position checked using radiographs and electrical stimulation. Electrode tip heated to 60°C for two minutes under general anaesthesia, further lesions as required after sensory testing in conscious patient. (n=39) pain relief at follow-up (2-20 months) 0.923 side effects unpleasant sensation in face n=8 loss of sensation in treated division n=9 corneal reflex affected n=6 keratitis n=2 anaesthetic dolorosa 0 conclusions, comments, and quality scores study design Sengupta, R. P., & Stunden, R. J. (1977). Radiofrequency thermocoagulati on of Gasserian ganglion and its rootlets for trigeminal neuralgia. British Medical Journal, 1(6054), 142143. authors’ conclusions: effective and relative harmless technique reviewer’s comments: incomplete data on how long each patient was followed for. case series n<50 9 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve Studies appraised as low quality study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (including adverse events) results RTR MVD patients with trigeminal neuralgia, who underwent these two interventions in one institution 1. radiofrequency trigeminal rhizotomy: one or two lesions at70-75°C for 60-90 seconds dependent on pain distribution and patient’s age (n=206) 2. microvascular decompression: offending vessel dissected and pushed away with a muscle pad or Gore-Tex sleeve. If no offending vessel, partial rhizotomy performed by pinching the nerve with bipolar forceps without current. (n=225) pain-free survival (Kaplan-Meier analysis) 2 years 50% 24% pain-free survival (Kaplan-Meier analysis) 4.5 years 25% pain-free survival (Kaplan-Meier analysis) 10 years <20% pain-free survival (Kaplan-Meier analysis) 20 years <10% validity / applicability yes no n/a n/s ? conclusions, comments, and quality scores randomised no method described n/a validity: ~/− precision: ~ applicability: ~/− similar at baseline n/s concealment n/a intention to treat n/a blinding appropriate no single blind no double blind no study design Tronnier, V., Rasche, D., Hamer, J., Kienle, A., & Kunze, S. (2001). Treatment of idiopathic trigeminal neuralgia:comp arsion of long term outcome after radiofrequency rhizotomy and microvascular decompression. Neurosurgery, 48(6), 12611267, discussion 1267-1268. historical control ~30% 35% 37% complications mortality hypacusis blind outcome assessment no 0.8% (n=3) 5.3% compliance OK n/a anacusis 2.6% follow-up OK yes facial paresis / tinnitus 0.9% each drop outs <20% no vertigo >14 days duration hypesthesia 2.2% generalisability ? 12% feasible / affordable ? cerebrospinal fluid fistula herpes labialis 0.8% all important outcomes considered balance between benefits and harms yes painful dysesthesia 3.0% overall quality: − authors’ conclusions: authors make direct comparison between treatments and conclude that MVD should be treatment of choice. reviewer’s comments: retrospective with significant loss to follow up. Microvascular decompression excluded from this project no 0.9% 10 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (including adverse events) patients with trigeminal neuralgia, no further details 1. radiofrequency rhizotomy, at 65-70°C for 1 min (n=235) 2. glycerol rhizotomy (Hakanson technique) no further details (n=36) 3. microvascular decompression, vessels causing compression ewere dissected away from nerve and Teflon felt interposed, patients without compressing vessels were given partial rhizotomy. (n=146) results validity / applicability yes no n/a n/s ? conclusions, comments, and quality scores validity: − precision: − applicability: − RF GR MVD initial pain relief 92% 83% 96% randomised no method described n/a pain recurrence nr 46% 9% similar at baseline n/s concealment n/a intention to treat n/a blinding appropriate no study design Lee, K. H., Chang, J. W., Park, Y. G., & Chung, S. S. (1997). Microvascular decompression and percutaneous rhizotomy in trigeminal neuralgia. Stereotactic & Functional Neurosurgery, 68(1-4 Pt 1), 196-199. historical control complications facial dysaesthesia mortality 5% nr 3% nr 0.3% 1.4% single blind no double blind no blind outcome assessment no compliance OK n/s follow-up OK no drop outs <20% n/s generalisability no feasible / affordable ? all important outcomes considered balance between benefits and harms no overall quality: − authors’ conclusions: microvascular decompression is procedure of choice for tolerant younger patients, for reduced sensory deficit reviewer’s comments: presentation of data and information methodology is poor no 11 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (include adverse events) glycerol rhizolysis Hakanson technique, 99.5% glycerol (0.20.4ml), CSF flow considered evidence of satisfactory needle placement, patient supine throughout (n=50) immediate pain relief radiofrequency lesion, electrical stimulation used to confirm electrode placement, 1 to 3 lesions at 70°C for 60 seconds (some variation implied) (n= 80) complications absence of corneal reflex n=3 sensory loss n=24 Results EGO GR RF 0.80 0.88 validity / applicability yes no n/a n/s ? conclusions, comments, and quality scores randomised no method described n/a validity: ~/− precision: − applicability: − similar at baseline ? concealment n/a intention to treat n/a blinding appropriate no single blind no double blind no study design Tan, L. K. S., Robinson, S. N., & Chatterjee, S. (1995). Glycerol versus radiofrequency rhizotomy: A comparison of their efficacy in the treatment of trigeminal neuralgia. British Journal of Neurosurgery, 9(2), 165-169. historical control retrospective analysis of case notes of patients with trigeminal neuralgia refractory to drug treatment st pain free at 1 review repeat within 1 year sensory loss with repeats no sensory loss no repeat anaesthesia dolorosa 0.68 0.42 0.65 0.25 n=12 N=66 n=7 / 24 N= 20 / 66 n= 12 / 50 N= 10 / 80 n=0 N=1 blind outcome assessment no compliance OK n/a follow-up OK no drop outs <20% ? generalisability no feasible / affordable ? all important outcomes considered no balance between benefits and harms no overall quality: − authors’ conclusions: glycerol rhizotomy preferred as first line treatment reviewer’s comments: authors make direct comparisons between effectiveness of interventions, not justifiable on basis of this type of study, retrospective analysis and lack of info on outcome assessment, follow up etc 12 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (including adverse events) inclusions: patients with idiopathic trigeminal neuralgia, over 50 years, diagnosis verified by CT scan, pain refractory to carbamazepine (6001200mg/day) (however 3 patients with multiple sclerosis and 4 with malignancy were included) glycerol injection (G): needle placed through foramen ovale using Hartel technique and pure glycerol injected. (n=77) RF thermocoagulation (RF): thermal lesions made at 80°C for 60 seconds (n=26) complications venous puncture during procedure results validity / applicability yes no n/a n/s ? conclusions, comments, and quality scores validity: − precision: − applicability: − G RF G+RF mean pain relief (method not described) 72% 72% 88% randomised no method described n/a time to recurrence 10.3 months (range 120) n=2 (3%) 10 months (range 318) n=2 (8%) 13 months (range 423) similar at baseline n/s concealment n/a n=2 (2%) intention to treat n/a blinding appropriate no single blind no double blind no study design Erdine, S., Yucel, A., & Ozyalcin, S. (1994). Longterm follow-up: Retrogasserian glycerol injection, radiofrequency thermocoagulati on and radiofrequency + glycerol injection for the treatment of trigeminal neuralgia. Pain Digest., 4(4), 279-282. historical control RF + glycerol: lesion created at 60°C for 45 seconds, pure glycerol 0.2-0.3cc injection (n=119) hematoma during procedure n=0 hyperesthesia n=2 (3%) n=2 (8%) N=4 (3%) blind outcome assessment no hypoesthesia n=3 (4%) N=10 (8%) compliance OK n/a keratitis n=1 (1%) n=10 (38%) n=1 (4%) N=2 (2%) follow-up OK no herpetic eruption n=0 n=1 (4%) N=0 drop outs <20% n/s anaesthesia dolorosa n=1 (1%) n=2 (8%) N=2 (2%) generalisability no feasible / affordable ? all important outcomes considered balance between benefits and harms no orbital hematoma n=1 (1%) n=1 (4%) n=0 n=1 (1%) N=0 overall quality: − authors’ conclusions: thermocoagulation and glycerol combined treatment is safe and effective reviewer’s comments: not enough information provided on patients, outcome evaluation, follow up no 13 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (including adverse events) inclusions: typical trigeminal neuralgia, all patients had CT scan; strictly standardised operative technique used in each intervention group, mean follow up of 24 months in each group percutaneous microcompression (PM), catheter inflated with 0.75ml of contrast - 1 to 10 minutes (Mullan and Lichtor technique) n=74 results PM RF MD complete pain relief at mean 2 year follow up 0.44 0.58 0.75 mean time to recurrence (months) 6.5 18.5 11.3 validity / applicability yes no n/a n/s ? conclusions, comments, and quality scores randomised no method described n/a validity: − precision: ~/− applicability: − similar at baseline n/s concealment n/a intention to treat n/a blinding appropriate no study design Meglio, M., Cioni, B., Moles, A., & Visocchi, M. (1990). Microvascular decompression versus percutaneous procedures for typical trigeminal neuralgia: Personal experience. Stereotactic & Functional Neurosurgery, 54(55), 76-79. historical control radiofrequency thermocoagulation (RF) carried out at 7580°C for 1-3 minutes n=33 microvascular decompression (MD), compressing vessel gently mobilised and held away with teflon felt. n=20 side effects marked dysesthesia permanent masticatory weakness ipsilateral hypoacusia and transient IV cranial nerve palsy marked dysesthesia 7% 10% 24% 0 5% single blind no double blind no blind outcome assessment no compliance OK n/a follow-up OK yes? drop outs <20% n/s generalisability no feasible / affordable ? all important outcomes considered balance between benefits and harms no overall quality: − authors’ conclusions: author makes claims about effectiveness of one procedure over another reviewer’s comments: insufficient information on reasons for allocation to each intervention, cannot compare directly. unclear information on follow up and outcome evaluation. no 14 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (including adverse events) 1.controlled differential thermocoagulation, Sweet and Wepsic technique (n=533) 2.glycerolization of trigeminal cistern, Hakanson technique (n=32) 3.compression of gasserian ganglion with a balloon catheter, Mullan and Lichtor without intratracheal intubation (n=159) Results EGO thermo GR comp early pain relief typical TN 0.991 0.625 0.916 early pain relief MS 1.0 validity / applicability yes no n/a n/s ? conclusions, comments, and quality scores randomised no method described n/a validity: − precision: − applicability: − similar at baseline n/s concealment n/a intention to treat n/a blinding appropriate no study design Fraioli, B., Esposito, V., Guidetti, B., Cruccu, G., & Manfredi, M. (1989). Treatment of Trigeminal Neuralgia by Thermocoagulat ion, Glycerolization and percutaneous Compression of the Gasserian Ganglion and /or Retrogasserian Rootlets: Longterm Results and Therapeutic Protocol. Neurosurgery, 24(2), 239-245. historical control typical drug refractory trigeminal neuralgia diagnosed strictly: attacks of lancinating and shooting pain triggered by facial movements / trigger zones; well-being between attacks, attacks of pain that are unilateral and confined to trigeminal divisions; long periods of relief obtained by treatment with carbamazepine. But also patients with trigeminal neuralgia secondary to multiple sclerosis, tumours; also atypical and postherpetic trigeminal neuralgia - small number of cases. 0 0.333 complications corneal reflex reduced 17% single blind no corneal reflex disappeared keratitis 3% double blind no blind outcome assessment no anaesthesia dolorosa 2% compliance OK n/a paresthesia requiring medical treatment 15% follow-up OK no drop outs <20% n/s persistent masticatory weakness 3% transient 6th nerve palsy 0.2% persistent masticatory weakness anaesthesia 2% 3% 9% 7% 7% 3% generalisability no feasible / affordable ? all important outcomes considered balance between benefits and harms yes? overall quality: − authors’ conclusions: authors make conclusions on relative merits of each intervention and propose a therapeutic protocol. reviewer’s comments: too much missing information to have confidence in results. Direct comparisons between interventions not justified. no 3% 15 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (including adverse events) Patients with trigeminal neuralgia – no explicit inclusion / exclusion criteria given. 1. Percutaneous thermorhizotomy (PT): 90 sec to 2 min coagulation performed at 65°C. If neuralgia is resistant further coagulations are performed at 70-75°C. Sweet and Wepsic technique. 2. Percutaneous microcompression– balloon inflated for 23 mins (not more than 4). Mullan and Lichtor technique recurrence rate at 3 years results PT MC 25% ‘similar’ validity / applicability yes no n/a n/s ? conclusions, comments, and quality scores randomised no method described n/a validity: − precision: − applicability: − similar at baseline n/s concealment n/a intention to treat n/a blinding appropriate no study design Frank, F., & Fabrizi, A. P. (1989). Percutaneous surgical treatment of trigeminal neuralgia. Acta Neurochirurgica , 97(3-4), 128130. historical control side effects transitory left VI cranial nerve palsy n=1 anaesthesia dolorosa n=4 n=2 n=0 transitory masticatory disorder n=55 n=18 corneal anaesthesia n=1 n=0 single blind no double blind no blind outcome assessment no compliance OK n/a follow-up OK no drop outs <20% n/s generalisability no feasible / affordable ? all important outcomes considered no balance between benefits and harms no overall quality: − authors’ conclusions: authors make comparisons between interventions’ effectiveness. they note indications for one over the other in certain patients. reviewer’s comments: minimal information given on outcomes, not helpful 16 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (including adverse events) instrumentation used which permits all 3 types of lesions or any combination of the 3. retrogasserian thermocoagulation (RT) (n=390), glycerol radiculolysis (GR) (n=61) and / or trigeminal balloon compression (TBC) (n=32). pain free results EGO RT FR TBC 0.82 0.82 0.66 validity / applicability yes no n/a n/s ? conclusions, comments, and quality scores randomised no method described n/a validity: − precision: − applicability: − similar at baseline n/s concealment n/a intention to treat n/a authors’ conclusions: blinding appropriate no single blind no double blind no reviewer’s comments: not enough information on methodology: follow up, inclusions study design Vladyka, V., & Subrt, O. (1989). The possibility of retrogasserian thermocoagulati on, glycerol radiculolysis and balloon compression in Meckel's cavity with a single surgical instrumentariu m. Zentralblatt fur Neurochirurgie, 50(3-4), 149152. historical control patients with tic douloureux, no further inclusions detailed pain free with medication 0.13 residual pain 0.03 without improvement 0.02 0.12 0.03 0.03 0.25 0.06 0.03 blind outcome assessment no compliance OK n/a follow-up OK n/s drop outs <20% n/s generalisability no feasible / affordable ? all important outcomes considered balance between benefits and harms no overall quality: − no 17 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (including adverse events) results EGO PTR MVC patients with idiopathic trigeminal neuralgia, all intolerant of or refractory to medical therapy. Posterior fossa procedure not offered to patients over 70 years or if considered a ‘poor risk’, 8 patients with TN 2y to multiple sclerosis were not considered for MVD. 1.percutaneous trigeminal rhizotomy, Sweet and Wepsic technique. temperature / duration of current not provided (PTR) (n=55) immediate failure 0.04 0.12 delayed recurrence 0.42 0.17 2.microvascular decompression (MVC), Jannetta method, , vascular compression / distortion of nerve was identified, offending vessel mobilised then separated from nerve by a piece of felt (n=24) 4 patients counted twice as they had both procedures complications study design Ferguson, G. G., Brett, D. C., Peerless, S. J., Barr, H. W., & Girvin, J. P. (1981). Trigeminal neuralgia: a comparison of the results of percutaneous rhizotomy and microvascular decompression. Canadian Journal of Neurological Sciences, 8(3), 207-214. historical control no other selection details provided. pain free (at 30, 28 months follow up) 0.54 0.71 validity / applicability yes no n/a n/s ? conclusions, comments, and quality scores randomised no method described n/a validity: ~/− precision: ~/− applicability: − similar at baseline n/s concealment n/a intention to treat n/a blinding appropriate no single blind no double blind no n=1 blind outcome assessment no corneal anaesthesia n=4 compliance OK n/a asymptomatic motor root involvement gait ataxia and vertigo n=16 follow-up OK yes n=3 drop outs <20% yes transient conductive hearing loss facial weakness n=3 generalisability ? n=3 feasible / affordable ? post operative wound infection post operative headache / vomiting n=1 all important outcomes considered no common balance between benefits and harms no mortality 0 anaesthesia dolorosa 0 overall quality: − authors’ conclusions: PTR useful for its safety in elderly patients, MVD nondestructive but long term efficacy unknown at this stage reviewer’s comments: complete follow up, but little detail on how patients were identified, allocated to each intervention, and evaluated microvascular decompression excluded from this project 18 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (including adverse events) results validity / applicability yes no n/a n/s ? conclusions, comments, and quality scores patients with idiopathic trigeminal neuralgia (= electric shock-like, paroxysmal pain without pathological findings on cranial MRI or CT scans). RF trigeminal rhizotomy, needle inserted towards temporal fossa then inserted through the foramen ovale to the preganglionic (retrogasserian) fibres of gasserian ganglion, guided by x-rays. Electrodes made lesions at 55-70°C. Duration not reported. Average 4 lesions per procedure. Cardiovascular signs monitored throughout. (n=160) complete pain relief (acute – time not provided) (n=1600) 0.976 randomised no case series score: 0.5 / 3 method described n/a complete pain relief at 5 years (of those who experienced it at any stage) (*n=719) 0.921 similar at baseline n/a concealment n/a authors’ conclusions: low risk procedure with high effectiveness for pain relief. Can be repeated safely. intention to treat n/a anaesthesia dolorosa n=12, 0.8% blinding appropriate n/a painful dysesthesia n=16, 1.0% single blind n/a absent corneal reflex n=91, 5.7% double blind n/a masseter paresis n=48, 3.0% blind outcome assessment n/a study design Kanpolat, Y., Savas, A., Bekar, A., & Berk, C. (2001). Percutaneous controlled radiofrequency trigeminal rhizotomy for the treatment of idiopathic trigeminal neuralgia:25 year experience with 1,600 patients. Neurosurgery, 48(3), 524-532. case series ‘patients who were older, who did not want microvascular decompression and those with poor medical status were selected’. masseter paralysis n=18, 1.1% compliance OK n/a transient cranial nerve paralysis permanent cranial nerve paralysis cerebrospinal fluid leak n=12, 0.75% follow-up OK yes n=2, 0.13% drop outs <20% no n=2, 0.13% generalisability no carotid-cavernous fistula n=1, 0.06% feasible / affordable ? aseptic meningitis n=1, 0.06% yes? mortality 0 all important outcomes considered balance between benefits and harms reviewer’s comments: retrospective case series seriously limits confidence in results. Long follow up but with dramatically reduced numbers over time e.g. 50% at 5 years. no 19 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (including adverse events) results all patients who underwent percutaneous RF thermocoagulation Jan ‘86 Dec ’90 for typical trigeminal neuralgia symptoms or patients with additional atypical features if pain character was paroxysmal (people with multiple sclerosis, brain tumour or previous injury to trigeminal nerve also included) Sweet and Wepsic technique. Needle inserted through foramen ovale and electrode tip positioned among the trigeminal rootlets using fluoroscopy. RF current applied (temperature/time varied between patients – 60 to 90°C for 90 to 540 seconds). Sensory response checked in conscious patient and further lesion applied if necessary. (n=81) immediate success rate 0.87 validity / applicability study design Yoon, K. B., Wiles, J. R., Miles, J. B., & Nurmikko, T. J. (1999). Longterm outcome of percutaneous thermocoagulati on for trigeminal neuralgia. Anaesthesia, 54(8), 803-808. case series pain free at 1 year (Kaplan-Meier) 0.65 pain free at 2 years (Kaplan-Meier) 0.49 pain free at 11 years (Kaplan-Meier) 0.26 yes no n/a n/s ? conclusions, comments, and quality scores randomised no case series score: 0.5 / 3 method described n/a similar at baseline n/a concealment n/a intention to treat n/a authors’ conclusions: success rate similar to other studies, pain returned for most after around 2 years. Patients with typical symptoms and those without prior surgery tended to achieve better results. blinding appropriate n/a single blind n/a double blind n/a blind outcome assessment n/a 20 (25%) compliance OK n/a corneal numbness 12 (15%) follow-up OK ? keratitis 2 (2%) drop outs <20% no masseter weakness 3 (4%) generalisability yes others 2 (2%) feasible / affordable ? all important outcomes considered balance between benefits and harms yes? side effects dysaesthesia reviewer’s comments: retrospective analysis – inherently incorporates considerable risk of bias. Very little patient data included. no 20 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (including adverse events) results validity / applicability yes no n/a n/s ? conclusions, comments, and quality scores patients with trigeminal neuralgia, no further inclusions provided radiofrequency rhizotomy performed under IV sedation, curved electrode used to create dense hypalgesia in the painful trigger zone. Procedure described in detail in a book (Tew, Operative neurosurgical techniques, 1995). (n=500) initial pain relief 0.98 randomised no case series score: 0.5 / 3 method described n/a authors’ conclusions: authors make direct comparisons between interventions paper includes historical comparisons with other author’s published work complications facial numbness 98% minor dysesthesia study design Taha, J. M., & Tew Jr, J. M. (1996). Comparison of surgical treatments for trigeminal neuralgia: reevaluation of radiofrequency rhizotomy.[see comment]. Neurosurgery, 38(5), 865-871. case series success of procedure 0.98 similar at baseline n/a concealment n/a pain recurrence 0.20 intention to treat n/a blinding appropriate n/a single blind n/a double blind n/a 9% blind outcome assessment n/a major dysesthesia 2% compliance OK n/a anaesthesia dolorosa 0.2% follow-up OK no corneal anaesthesia 3% drop outs <20% n/s keratitis 0.6% generalisability no trigeminal motor dysfunction perioperative morbidity 0.7% feasible / affordable ? 0.6% no perioperative mortality 0 all important outcomes considered balance between benefits and harms reviewer’s comments: large retrospective study, not enough information on own series of patients – focussed on making comparisons with selected articles which are not justifiable no 21 Evidence Tables: Neuroablation-Radiofrequency Neurotomy Trigeminal Nerve study authors and year participants inclusion exclusion exposure / comparison treatment (number in each group) outcomes (including adverse events) results patients with trigeminal neuralgia, no inclusion criteria listed, no sampling frame described, no selection process described percutaneous RF coagulation of the Gasserian ganglion (‘similar to Sweet & Wepsic’) – details previously reported in 2 spanish language papers which are referenced (n=98) recurrence (=return to requirement of medication / further treatment) at 1 year n=13 recurrence at 2 years n=7 validity / applicability study design Piquer, J., Joanes, V., Roldan, P., Barcia-Salorio, J. L., & Masbout, G. (1987). Longterm results of percutaneous gasserian ganglion lesions. Acta Neurochirurgica Supplementum, 39, 139-141. recurrence at 3 years recurrence at 4 years n=2 side effects sensory loss (substantial) case series n=8 31 yes no n/a n/s ? conclusions, comments, and quality scores randomised no case series score: 0 / 3 method described n/a similar at baseline n/a concealment n/a intention to treat n/a authors’ conclusions: well tolerated procedure. patients with marked sensory deficits had reduced risk of recurrence. blinding appropriate n/a single blind n/a double blind n/a blind outcome assessment n/a compliance OK n/a sensory loss (moderate deficit) 42 follow-up OK no sensory loss (partial or no permanent deficit) corneal sensory loss 25 drop outs <20% ? 18 generalisability no keratitis 3 feasible / affordable ? anaesthesia dolorosa 2 all important outcomes considered no herpes on affected trigeminal division 1 balance between benefits and harms no reviewer’s comments: not enough data provided to give any confidence in success rate. Although long-term follow up reportedly took place, little detail is given to allow rate calculations. 22