Download Neuroablation: Radiofrequency (RF) Neurotomy: Trigeminal

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