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Pulsed RF - Nikolai Bogduk
Pulsed RF - Nikolai Bogduk
Pulsed RF - Nikolai Bogduk
200675
396407MiscellaneousISIS Position Paper on Pulsed RFBogduk
PA I N M E D I C I N E
Volume 7 Number 5 2006
Position Papers
Pulsed Radiofrequency
E+
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65 C isotherm Figure 4 The geometry of the lesion generated by a ther-
mal radiofrequency current. The volume of tissue coagu-
lated assumes the shape of a prolate spheroid, i.e., elliptical
in longitudinal section and circular in transverse section.
Figure 3 Effects near the tip of the electrode subjected to The radial extent (r) of the lesion beyond the surface of the
a radiofrequency current. Electric field lines converge onto electrode and its distal extent (d) beyond the tip of the
the tip of the electrode. Charged molecules oscillate with electrode are functions of the width (w) of the electrode.
the electric field (E). Temperatures are higher where the The inset shows the actual dimensions of lesions generated
electric field is denser. Isotherms radiate concentrically by two types of electrodes [9,10]. SMK, RRE = electrode
from the surface of the electrode. types manufactured by Radionics Inc., Burlington, MA.
ISIS Position Paper on Pulsed RF 399
Pathology Efficacy
If the electrode is placed sufciently close to a Thermal RF neurotomy has an established repu-
target nerve, that nerve will be incorporated into tation of efcacy for the treatment of trigeminal
the lesion formed around the electrode. If an elec- neuralgia. Numerous descriptive studies have
trode is inserted into a DRG, heating it to 67C recorded complete pain relief in up to 80% of
produces a hemorrhagic lesion with total loss of patients treated, with follow-up periods in excess
myelinated bers [11]. If a large electrode (14G) of 1 year, and in some studies, up to 11 and
is placed beside a DRG, thermal lesions of 45C, 14 years [19,20]. The efcacy of cervical RF cor-
55C, 65C, 75C, and 85C produce total loss of dotomy has similarly been established in patients
unmyelinated nerve bers and near total loss of with pain of neoplastic origin, although the suc-
myelinated bers [12]. In the sciatic nerve, an cess of cervical RF cordotomy for nonmalignant
80C thermal lesion produces extensive Wallerian pain has been less encouraging.
degeneration of the axons, and disruption of their When applied to peripheral nerves, thermal RF
myelin sheaths and epineurium [13]. In the saphe- neurotomy has been rigorously tested only when
nous nerve, lesions made at 70C destroy both the target nerves have been the medial branches
myelinated and unmyelinated bers [14]. of the lumbar or cervical dorsal rami.
Although there is an abundant literature on a
Physiology procedure that was called lumbar facet denerva-
An early study claimed that RF coagulation selec- tion, most of these reports were awed as a
tively destroyed on A and C bers and hence suboptimal surgical technique was employed.
could be selective for preventing nociception [15]. Electrodes were either placed nowhere near the
This contention, however, has not been borne out target nerve or they were not placed parallel to
by subsequent experiments, and is incompatible them [19]. It transpires that there is very little
with the pathology data, which show that RF literature on the efcacy of lumbar, thermal RF
coagulation affects all nerves, myelinated and neurotomy. What little there is, however, is sup-
unmyelinated. EMG studies have shown that even portive. A placebo-controlled trial showed that the
alpha motor neurons are coagulated [16]. RF neu- effect of thermal neurotomy could not be attrib-
rotomy, therefore, is a nonselective method of uted to placebo [21]. A descriptive study, which
coagulating nerves. used an anatomically accurate technique was uti-
lized, showed that 60% of patients maintained at
Technique least 80% relief of pain for 12 months, and 80%
The technique of thermal RF neurotomy requires of patients maintained at least 60% relief for this
accurate placement of the electrode onto the tar- period [16]. Another outcome study showed that
get nerve. In the case of medial branch neurotomy if pain recurs, relief may be successfully reinstated
for spinal pain performed under uoroscopic by repeating the neurotomy [22].
guidance, the electrode must be carefully juxta- For cervical thermal RF neurotomy, the litera-
posed parallel to the target nerve. Once it has been ture is stronger. A placebo-controlled trial showed
placed, the position of the electrode must be held that the effects of cervical medial branch neurot-
in place while the surrounding tissue temperature omy were genuine [18]. Follow-up studies showed
is increased to the operating temperature and that the median duration of complete relief of pain
maintained until thermal equilibrium is achieved. was over 400 days, and that if symptoms recurred,
Typically, this equilibrium occurs after 60 seconds. relief could be reinstated by repeat neurotomy
Ideally, lesions must be made in several locations [17,23]. Thermal RF neurotomy of the third
along the course of the target nerve in order to occipital nerve successfully relieves cervicogenic
accommodate possible variations in the exact headache stemming from the C2-3 zygapophysial
actual location of the nerve. These requirements joint [24]. The efcacy of cervical medial branch
render the procedure of thermal RF neurotomy neurotomy is not signicantly different in patients
time-consuming and relatively arduous. Between with pending litigation and those not subject to
1 and 2 hours operating time may be required to litigation [17,2325].
thoroughly coagulate two target nerves [17,18]. Signicant features of the literature on medial
These features are pertinent because other RF branch neurotomy are the magnitude and duration
procedures are rendered attractive by promising a of effect. For lumbar medial branch neurotomy,
substantially shorter operating time. the benchmark is 80% relief of pain or greater
400 Bogduk
sustained for 12 months. For cervical medial duced in the DRG. Explicitly, they have stated that
branch neurotomy, it is complete (100%) relief of it is not the intention of this procedure to coagulate
pain sustained for 1 year. Complete relief, not par- the entire ganglion. Rather, the procedure is
tial relief, is the benchmark. intended to expose the dorsal root ganglion to tem-
peratures that prevail in the peripheral part of an
RF lesion to preserve the large myelinated bers
Intradiscal Thermal RF and to deactivate the small myelinated bers [31].
The conventional application of thermal RF Critics are perplexed by the inherent paradox in
requires placing the electrode onto the target this rationale: the DRG is referred to as the target
nerve, so as to incorporate that nerve into the but the lesion must not be so close as to actually
small lesion produced by the electrode. A depar- cause signicant damage to the target [32]. The
ture from this paradigm arose when thermal RF literature [15] cited by the proponents [31] as evi-
was used to treat discogenic low back pain. The dence of a differential effect on small diameter and
origin of this departure is difcult to trace. Inves- large diameter afferents has been refuted [14].
tigators who subsequently studied the procedure This paradox invites the interpretation that per-
[26,27] referred to various personal communica- haps the lesion does nothing to the nerve, and the
tions and unpublished sources dating to 1994. outcomes are due to no more than a placebo effect.
Intradiscal RF involved placing the tip of the This paradox is reected in the empiric clinical
electrode into the center of the nucleus pulposus data.
of the target disk. It was recognized that the lesion A morphological study in goats showed that
produced in this location did not coagulate nerves, DRG-RF produced no destructive changes in the
for the nucleus pulposus is devoid of nerves. How- nerve, provided that the electrode was placed adja-
ever, proponents argued that the electric eld pro- cent to the ganglion [11]. If placed within the
duced around the electrode was sufcient to heat ganglion, the lesion destroys myelinated bers [11].
and destroy nerve bers in the outer anulus bro-
sus, and thereby provide relief of pain. This belief Efficacy
was based on a theoretical assessment of the mag- The outcomes of RF-DRG are not consistent
nitude of the electric eld and the proposition that across cervical [4,7], thoracic [5,6], and lumbar
temperatures of 45C would be achieved in the [33,34] applications. The outcomes of cervical RF-
outer anulus, and would be enough to coagulate DRG are less than modest, even in a controlled
nerves. trial. For lumbar RF-DRG, a rigorous controlled
Cadaver studies rapidly dispelled this notion trial has shown that sham therapy achieves at least
[26,28]. Signicant heating did not occur in the equivalent outcomes to those of active therapy.
outer anulus. Nevertheless, the procedure contin- Thoracic RF-DRG has not been subjected to a
ued to enjoy some popularity in some circles. controlled trial, but it might be effective for cer-
A controlled trial eventually demonstrated that tain types of thoracic pain for which there is not
intradiscal RF achieved no greater relief of pain an analog at cervical and lumbar levels [5,6]. The
than sham therapy [27]. What were promoted as available data hint at the possibility that thoracic
successful outcomes in earlier observational stud- RF-DRG could be useful for postsurgical pain [5],
ies [29] amounted to no more than placebo although not for neuralgias [6].
responses. A later study showed no gain in out-
come when an 80C lesion maintained for
360 seconds instead of 120 seconds [30]. Although Pulsed RF
patients reported substantial reductions in pain
Introduction
immediately after the procedure, those results rap-
idly attenuated until baseline pain scores were It is not evident from their publication why Slap-
restored at 2 months. pendel et al. [8] undertook to compare the effects
of 40C and 67C RF-DRG. Their article simply
announces that the study was performed. Table 1
RF-DRG
summarizes their results.
These data are remarkable for two features.
Rationale First, between groups there is no signicant dif-
Proponents of RF-DRG believe that a therapeutic ference at any time. Within groups, there is an
effect may be achieved by a partial nerve lesion pro- initial decrease in pain scores, but the decrease is
ISIS Position Paper on Pulsed RF 401
is created has been borne out by laboratory sient (5 minutes), which is consistent with no sig-
studies. nicant permanent lesion having been made.
A study that predated the concept of pulsed RF A third study examined the effects on cells in
showed that applying a continuous RF current to a the dorsal horn of the rat spinal cord following
peripheral nerve, with a tip temperature of 40C pulsed RF application to the C6 DRG [39]. The
to 45C, resulted in reversible conduction block in C6 DRG was exposed to continuous RF or pulsed
the nerve [37]. Upon cessation of the current, con- RF at 38C. The animals were sacriced 3 hours
duction promptly reverted to normal. Brodkey after exposure, and immunohistochemical assays
demonstrated that the same effect was achieved by for c-fos reactivity performed. Animals treated with
heating the nerve using water circulated through pulsed RF at 38C exhibited increased expression
a coil around the nerve [37]. of c-fos in lamina I and lamina II. These effects
Thus, heating a nerve to low temperatures (40 were not seen in animals treated with continuous
45C) temporarily blocks conduction along the RF at 38C.
nerve, but the rapid recovery of function indicates These results indicate that pulsed RF activates
that no physiologic lesion is produced. These sensory bers in the DRG and the spinal neurons
experiments do not exclude a possible induced to which they relay. The clinical implications of
electrical effect of RF current, but the fact that this nding are not known. The duration of
heated water achieved the same effect strongly changes in dorsal horn c-fos are not known, as
suggests that it is the low level of heat produced, animals were sacriced 3 hours after RF exposure.
not the current itself, which was responsible for The fact that continuous RF did not produce
the temporary conduction block. changes in dorsal horn c-fos indicates that it is not
In a study using slices of hippocampus as the electrode current itself but its delivery in pulses
target tissue [38], two protocols of pulsed RF that is responsible for the effect.
(one at 38C and one at 42C) and a 42C continu- Somewhat contrary results were obtained in
ous (thermal) RF current were applied for another study [40]. It examined the effects on dor-
120 seconds. The continuous current reduced sal horn cells of both continuous and pulsed RF
excitatory postsynaptic potentials (EPSPs) to less applied to the C6 DRG compared with sham
than 50% of normal amplitude, for the duration treatment. Both forms of RF application induced
of the experiment (25 minutes). The 38C pulsed increased c-fos expression in the dorsal horn. This
RF reduced EPSPs to 75% normal amplitude for contradicts a specic effect attributable to the
ve minutes after application. Thereafter, normal delivery of current in pulses.
amplitudes recovered. The 42C pulsed RF Collectively the results of these studies provide
reduced EPSPs to 50% normal amplitude for extremely limited insight into the potential phys-
5 minutes. Thereafter, normal amplitudes iological effects of pulsed RF. The study of Brod-
recovered. key et al. [37] did not address the effects of pulsed
Beyond 2,000 m from the electrode, neither of RF; but it established a reference point. Heating a
the pulsed RF protocols produced any lesions in nerve temporarily blocks conduction along it.
the tissue; neither did the continuous thermal pro- This is compatible with the effects observed by
tocol. Between 500 m and 1,000 m, tissue dam- Cahana et al. [38] caused by a continuous 42C RF
age occurred with the thermal protocol but not lesion, but not pulsed RF at 38C or 42C.
with either pulsed protocols. Within 500 m, all In contrast to continuous RF lesions, pulsed RF
protocols all produced tissue damage. seems to have limited effects. It transiently sup-
These results show the expected effect of even presses, but does not abolish, EPSPs in tissue
a low temperature continuous RF thermal RF slices [38], and also seems to activate a subset of
lesion. Tissues were coagulated to a distance central spinal cord neurons [39]. Specically, how-
slightly greater than one electrode-width from the ever, pulsed RF does not produce a tissue lesion.
surface of the electrode (1 mm). This coagulation Any therapeutic effect, therefore, would seem to
was consistent with marked reduction in function be akin to a brief and mild electrical stimulation,
of the affected tissues (EPSP > 50% reduced for at perhaps not unlike the effects of a brief application
least 25 minutes). of transcutaneous nerve stimulator or an im-
In contrast, both pulsed RF protocols produced planted nerve stimulator.
only a minimal lesion immediately around the sur- The ndings that pulsed RF, and continuous
face of the electrode (<0.5 mm). Although neural RF for that matter, increase expression of c-fos do
function was suppressed, the effect was only tran- not provide an explanation for the effects of RF.
ISIS Position Paper on Pulsed RF 403
Expression of c-fos is no more than a marker of The effects of continuous RF were poor.
increased cellular metabolic activity; it is not even Indeed, the authors commented that they aban-
specic for nociceptive pathways. It indicates only doned this intervention because of the high failure
that cells are activated. It does not distinguish rate [35]. This appraisal of continuous RF is at
between inhibitory and excitatory activity. It is not direct odds with how Slappendel et al. [8] por-
evidence that patients will be relieved of their pain. trayed their outcomes with the same procedure.
For such reasons, an editorial [41] concluded that Slappendal et al. [8] considered their meager out-
. . . basic scientic studies in the neurobiology of comes with 40C RF-DRG to be sufcient to war-
pain models and analgesic techniques are not a rant exploration of the mechanism by which it was
substitute for randomized controlled clinical trials, therapeutic; which in turn was the step that gave
and studies such as that of van Zundert et al. [41] rise to pulsed RF. It is clearly ironic, therefore, that
do not justify using the technique clinically. Sluijter et al. [35] found and considered the results
A revised theory has sought to convert the orig- of the identical procedure to be so poor as to
inal, purely electrical model into a thermal one warrant abandonment.
[42]. The theory proposes that, during each pulse, Meanwhile, results of pulsed RF in this study
the electrode is heated temporarily, and that this were obviously better, at least at 6 weeks. Unfor-
heat is responsible for the therapeutic effect. An tunately, the report of outcomes was severely lim-
accompanying study, using nite-element model- ited. Global perceived effect is not the same as
ing, explored the magnitude of this effect. It relief of pain; and no other outcome measures
showed that the point of the electrode did, indeed, were provided. Nor was there any longer-term
produce heat. However, the range of inuence was follow-up. At best, it might only be deduced from
limited. Heat was generated at 0.3 mm from the this study that pulsed RF offers a short-term ben-
tip, but was proportional to the intensity of stim- et to some patients with radicular pain.
ulation. Large increases in temperature occurred The second study [35] involved 20 patients
only at voltages well above those commonly used with persistent leg pain after surgery. Five were
in practice. Meanwhile, the theory also still holds excluded because they did not respond to diagnos-
out that the electric eld of pulsed RF might depo- tic blocks. Of the 15 remaining, eight were said to
larize and disrupt nerve cell membranes. have obtained a satisfactory result, dened as a
greater than 2-point improvement in pain scores
Efficacy (range: 24), at 6 months after treatment. Two of
Clinical data on the efcacy of pulsed RF are these had a recurrence between 6 and 12 months.
extremely limited. The worldwide popularity of The fate of the others was not reported.
pulsed RF treatment is severely disproportionate This denition of success is somewhat gener-
to the volume and quality of the available litera- ous, and the sample-size is small. Although these
ture and the efcacy that it describes. data suggest some degree of benet, the results
One publication [35] reports two briey cannot be attributed to pulsed RF, for no controls
described studies. In the rst, patients were treated were used.
with either pulsed RF or continuous RF applied A case report [43] ventured that pulsed RF of
to a DRG. The anatomical location of the target the sphenopalatine ganglion relieved a patient of
nerve (cervical, lumbar) was not given. Both forms posttraumatic headache. That report, however,
of RF were delivered at 42C. Table 2 shows the did not provide data by which to distinguish the
results at 6 weeks. No other outcome measures effects of pulsed RF from those of the local anes-
were provided. thetic and corticosteroids that were injected onto
the ganglion at the time of operation.
In another study [44], the target for pulsed RF
was not a DRG but the medial branches of the
Table 2 The reported results of pulsed radiofrequency
treatment [35]
cervical and lumbar dorsal rami. Here, the authors
reported that 68 of 114 patients (60%) obtained
Global Perceived Effect at least 50% relief of pain for a minimum of
N (%)
1.5 months. On average, the relief lasted
Treatment N >75% 5075% <50% 3.9 1.9 months.
Continuous RF 24 1 (4) 2 (8) 21 (88) These results paint a modest picture of the ef-
Pulsed RF 36 20 (56) 11 (30) 5 (14) cacy of pulsed RF delivered to the medial
RF = radiofrequency. branches. No patients were rendered pain-free,
404 Bogduk
and relief persisted for only a very short period. These approaches differ not only in the quality
There was no control group. Recall that the and quantity of literature available, but with
benchmark set by cervical RF thermal neurotomy respect to mechanism, rationale, and outcomes.
is complete relief, and for lumbar RF thermal neu- For thermal RF neurotomy, there is a strong
rotomy, 80% relief, sustained for 1 year. biological basis. RF current is used to heat tissue,
Thus, it is not evident if the observed outcomes which subsequently results in a pathologic, histo-
from the aforementioned studies could be attrib- logically veriable tissue lesion, and there is no
uted to the pulsed RF. For relief that is moderate dispute of this being the objective of the proce-
in magnitude and limited in duration such as those dure. There is strong evidence of outcome, not
reported by Mikeladze et al. [43], controls are only with respect to relief of pain [16,1719,
essential in order to exclude nonspecic treatment 23,24] but also in terms of restoration of function
effects. For reference, Marks et al. [45] found that [1618,23,24], and even resolution of psychologi-
21% of their patients reported good relief con- cal distress [48]. The procedure has been vindi-
tinuing at 1 month, and 14% at 3 months, simply cated by placebo-controlled trials [18,21]. The
after undergoing anesthetic medial branch blocks. relief of pain from properly performed RF neuro-
An audit of selected patients introduced an tomy is profound. The benchmark is total relief of
additional indication [46]. The authors described pain [17,18,23,24] or nearly so [16]. The nominal
18 patients, with chronic neck and arm pain, who duration of relief is 1 year [1618,23]. Although
were selected for treatment if they obtained at pain may recur in some patients as the peripheral
least 50% relief of their pain following diagnostic nerve regenerates, relief can be successfully rein-
segmental nerve blocks. They underwent pulsed stated by repeating the neurotomy [17,18,2224].
RF of the DRG of the previously anesthetized What is clearly evident from the literature is
nerve. Of these patients, 13 reported greater than that pulsed RF does not produce a lesion [38].
50% improvement at 68 weeks, diminishing to Therefore, pulsed RF cannot be represented as a
10 by 311 months, and six at 1 year. The authors procedure resulting in nerve destruction, neurot-
were guarded in their discussion. They wrote that: omy, axontomesis, neurotemesis, gangloionolysis,
this clinical audit . . . does not allow us to draw rhizotomy, or any other noun connoting tissue
denitive conclusions. Nevertheless, they offered damage or destruction. In this respect, pulsed RF
that the results justify the start of a randomized is clearly a different procedure from thermal RF.
controlled trial. The differences between thermal RF and
A recent study attests to a major departure from pulsed RF are as follows:
the paradigm and application of pulsed RF. It pro-
motes intradiscal pulsed RF for the treatment of Pulsed radiofrequency is not equivalent to ther-
mal radiofrequency. It is not a substitute for thermal
discogenic pain [47]. The electrode is placed in the radiofrequency in conditions for which thermal
center of the nucleus pulposus, where no nerves radiofrequency has an established and proven
efcacy. There is no evidence that pulsed radio-
are present. frequency replicates the efcacy of thermal radio-
The study described outstanding outcomes frequency. The available data indicate that pulsed
radiofrequency is markedly inferior in these
in eight patients with discogenic pain, six of instances [44].
whom were followed for 1 week, and ve for
625 months. No controls were used. If pulsed radiofrequency is misrepresented as the
same procedure or an equivalent alternative to ther-
The mechanism of effect is dissonant with any mal radiofrequency, the inferior outcomes of the
of the theories of pulsed RF. It cannot be attrib- former may likely be misattributed to the latter.
(This has already happened in Switzerland where
uted to an electric eld effect on nerves in the insurers had imposed bans on reimbursements for
vicinity of the electrode-tip. It cannot be attrib- any type of radiofrequency treatment because of the
poor outcomes of pulsed radiofrequency [49]).
uted to pulsed heat, within 0.3 mm of the elec-
trode, as proposed by the revised theory of pulsed Pulsed RF is an attractive procedure on several
RF [42]. Rather, the purported mechanism is a counts. It is simpler than thermal RF. Electrodes
remote effect of the pulsed electric eld on nerves can be introduced in the same manner as needles
in the outer anulus. are used for diagnostic blocks; they do not need to
be positioned laboriously and meticulously as is
required for thermal RF. Because accurate place-
Discussion
ment of electrodes is not critical, this also renders
There are stark differences between thermal RF pulsed RF a faster procedure than thermal RF. It
lesioning techniques and pulsed RF treatment. would not be surprising, therefore, if some prac-
ISIS Position Paper on Pulsed RF 405
titioners have adopted pulsed RF simply because of efcacy become available. Health care adminis-
it is a quicker, easier procedure. trators must also understand that pulsed RF and
Observer bias is probably another factor. Prac- thermal RF are different, nonequivalent proce-
titioners who adopt the procedure are likely to dures, having differing outcomes, and involving
remember their successful cases, but forget the different degrees of medical risk, physician time
failures. Moreover, their impressions of the effec- and training.
tiveness of the procedure are likely to be based on
immediate responses or short-term follow-up at
best. They are unlikely to be aware of the attenu- References
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