NEW TECHNOLOGY
Recent Innovations in Interventional Pain Treatment
By John Paggioli, MD
SPINAL CORD STIMULATION
Spinal cord stimulation (SCS) has been performed for 30 years. It is
FDA approved for post laminectomy syndrome and complex regional
pain syndrome such as reflex sympathetic dystrophy. The last 15
years have seen the number of off label but successfully treated
conditions expand to pain that is not somatic, including chronic
ischemia (inoperable angina and peripheral vascular disease),
visceral pain including chronic pancreatitis and pelvic pain, post
stroke pain, phantom limb pain, and post herpetic neuralgia.
The last 5 years have seen more innovation from the device industry,
such as rechargeable pulse generators that can last 9 years, as well
as MRI compatible systems. The pulse generators have become
more complex allowing for new programming parameters that
show evidence of increased effectiveness in suppressing chronic
pain. Spinal cord stimulator leads are placed percutaneously into
the epidural space of the thoracic or cervical regions and stimulate
the posterior columns which carry large myelinated A-beta fibers
that mediate touch and vibration. These fibers stimulate inhibitory
interneurons, which decrease firing in unmyelinated or thinly
myelinated C and A-delta fibers. The inhibition occurs in the dorsal
horn of the spinal cord. The pain pathway is slower and travels
in the spinal-thalamic tract, while the touch/vibration pathway is
faster and travels up the dorsal columns to the thalamus where
both types of fibers meet again. The stimulation that travels
to the thalamus again blocks the pain fibers through inhibitory
interneurons. To be effective, the patient needs to feel a slight
tingling or vibration in the painful body part. This is accomplished
during the trial phase with the patient awake, giving input as to
where the lead location should be.
The spinal cord stimulator with pulse generators works well for
arm and leg pain, but is unreliable for axial neck and low back
pain. If the axial pain is somatic and can be induced by movement
(flexion or disk pain and extension for facet pain) then stimulation
will not suppress pain. Some axial pain that is constant, horizontal,
unrelated to movement, and especially if described as throbbing or
burning, should be amenable to SCS. However, the dorsal column
fibers for axial pain are deeper in the cord, and to stimulate these
fibers the voltage needs to be turned up so high that the pain will
be felt in the leg or arm. This stimulation may interfere with balance
and gait in addition to triggering pain.
The traditional stimulation parameters are voltage (strength),
frequency (discharges/second), and pulse width (time duration of
each discharge). The device companies realized that to stimulate
the deep fibers to the axial neck or low back, the “holy grail” of
18 THE OPEN JOURNAL
spinal cord stimulation, a high “charge density” without increasing
voltage needed to be achieved. All the new SCS devices have
increased rate capability of the batteries.
Traditional rates are 50-100 Hz (cycles/second). Nevro, an SCS
device company, invented a pulse generator that fires at 10,000
Hz. There is so much charge delivered to the cord that the voltage
is low, thus patients don’t feel stimulation. The Nevro spinal cord
stimulator improved low back pain relief with a paresthesia free
system compared to traditional SCS. The problem with Nevro’s
pulse generator is that the battery is large and uncomfortable for
small patients. It needs to be recharged daily, and it is not MRI
compatible.
Boston Scientific, a competitor in the SCS device business,
conducted a randomized trial in Europe comparing 10,000 HZ vs
1,000 HZ stimulation with crossover. The patients had no preference:
both high speeds were equally effective for low back pain. The
Boston Scientific study showed that 10K Hz, daily recharging, and a
large battery were ultimately unnecessary. Patients with all systems
now can receive paresthesia free or traditional SCS. They even have
the option to switch one for another should their first choice become
less effective.
Abbott, another SCS device company, markets a pulse generator
capable of both traditional stimulation and burst stimulation, the
latter consisting of five rapid pulses at a rate of 500HZ, followed by
a pause. The sequence is then repeated at 40HZ. In a multicenter
trial 173 patients were randomized to receive traditional paresthesia
based (tonic) stimulation for 12 weeks. Following this regiment the
study group was crossed over to sub-threshold (not perceived) burst
stimulation for 12 weeks. 70% of the patients preferred the burst
stimulation, 20% preferred tonic, and 10% had no preference. Burst
stimulation proved superior for both axial and limb pain. The results
were impressive, and Abbott was awarded superiority labelling for
its SCS device.
One potential advantage of the Abbott system is that it may
decrease the emotional response to pain, not just the intensity.
Animal and human studies show that some neurons in the brain
fire tonically, and others have burst patterns of firing. This was
found to be the case in treating tinnitus with auditory cortex brain
stimulation. The neurons causing tone tinnitus fire tonically, and
tonic stimulation suppresses them. Neurons causing white noise
tinnitus fire with a burst pattern, and tonic stimulation does not
suppress this. A neurosurgeon invented a pulse generator capable
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of burst stimulation that mimics the firing rates and frequency of
certain brain neurons. This stimulation was found to reduce noise
tinnitus. Abbott subsequently bought the rights to this patent.
Studies using functional imaging, including functional MRI and
PET scanning, show that tonic stimulation reduces the lateral pain
pathway which signals the location and intensity of pain. Burst
stimulation reduces both the pain localizing pathway as well as
the limbic system (medial pathway) response to pain. The anterior
cingulate cortex was the location of cingulotomy (lobotomy) that
caused psychiatric patients to not care or react to their negative
feelings. Abbott justifiably claims their system allows for some
degree of electrical lobotomy. While aversion and negative emotion
have an evolutionary survival benefit, they can be harmful in
patients with chronic pain.
A second potential advantage of the Abbott System is the possibility
that it sinks deeper into the cord to stimulate fibers from the low
back and feet without the need for painful, paresthesia causing
high voltage. Evidence for this comes from an observational
study of 15 patients whose permanent leads were placed under
general anesthesia, using systems from the 4 SCS companies. The
neurosurgeons used SSEP monitoring for lead location and studied
EMG responses by placing needles in the muscle groups of both
legs and the back.
To cause EMG firing, the stimulation either must travel to the
anterior part of the cord or retrograde down the motor neuron
to the muscle. Abbot Burst had the most energy efficient system
which resulted in EMG firing at the lowest energy. The result was
that the muscles to the foot were stimulated before the rest of
the leg. These fibers are deeper in the cord, along with the back
fibers, showing an advantage of the Abbott System for hard to
stimulate areas. Medtronic and Nevro systems did not cause EMG
firing. Boston Scientific’s burst program did stimulate the legs, but
stimulated foot EMG last and at a much higher current than Abbot’s
program.
The Abbott system also has a technically improved stimulator
lead for dorsal root ganglion stimulation: smaller and softer leads
that are placed epidurally and steered to a neural foramen. These
leads are most useful for localized pain that is difficult to control
with traditional SCS leads, including post herpetic neuralgia, post
thoracotomy and post mastectomy pain (thoracic DRG), post inguinal
herniorrhaphy pain (T12/L1DRG leads), pelvic/rectal pain (sacral root
stimulation) and diabetic neuropathy (L5/S1DRG leads).
A limitation of the Abbott pulse generator is that it is MRI
conditional. MRI energy must be manually limited to a SAR of .8
Watts/KG for no more than 30 minutes. This restriction will not
compromise limb imaging, but may reduce the quality of spine
and CNS scans. Additionally, the battery that allows for MRI
imaging is not rechargeable and has 2 sizes. The larger one can be
NEW TECHNOLOGY
uncomfortable for smaller patients, but lasts 5-7 years. It will last
less time if the more energy expending tonic programming is chosen.
The smaller battery can last 3-5 years with burst programming.
Boston Scientific’s pulse generator has the most programming
capability. The leads come with 8 or 16 contacts/lead. The 16
contact spans more vertebral levels and can stimulate back and leg
fibers. Each electrode on the lead is independently programmable
with different current per contact. The programming uses an
interesting algorithm. The company representative in the O.R. has a
computerized representation of the patient’s body. The painful areas
are marked with color representing the location of the leads to be
placed by the physician. A computer algorithm then quickly finds
the best stimulation parameters, including charge and current for
all contacts. Additionally, there is a joy stick whereby the patient is
asked where they feel the stimulation and for subtle refinements.
The company representative moves the joystick in response, and
the computer then changes contact charge and current accordingly.
The Boston Scientific battery is capable of alternating between
tonic stimulation and burst stimulation. Its pulse generator is MRI
conditional; but a SAR limit of 2 watts/kg will not compromise MRI
quality.
Medtronic does not have burst capability, and the pulse generator
rates can go to 1,200 Hz and which they call “high density”
stimulation. At the latter’s rate the stimulation voltage is lower
and below patient perception. They have the smallest, most
comfortable pulse generator and the system is fully MRI compatible.
An interesting advancement in the Medtronic model is an
accelerometer within the pulse generator which senses a patient’s
change in position. The stimulation strength is adjusted accordingly.
When patients lie down stimulation gets stronger, and when they
stand up it gets weaker. Patients do not have to adjust the voltage
as the battery will do this automatically. It is rechargeable and will
last 7-9 years.
Since the neck is very mobile sub-perception threshold stimulation
with either high frequency or burst stimulation may be an advantage
in cervical stimulation. Movement will alter the strength of the
stimulation, which some patients find annoying. Cervical stimulation
using sub-threshold stimulation may allow for successful
stimulation of trigeminal related pain including headaches and
atypical facial pain. Stimulator leads placed at C2/C3 can stimulate
the trigeminal nucleus caudalis. Inputs from the face descend
into the cervical cord and synapse at the nucleus caudalis before
ascending to the trigeminal ganglion.
In summary, all companies have advances and the best choices
for each patient depends on the location of their pain. Additional
factors to consider are MRI compatibility and pulse generator
capabilities, desired programming parameters, battery size,
recharging frequency, and lifespan.
Continued on page 20
FALL 2018 19
 NEW TECHNOLOGY
RADIOFREQUENCY
Radiofrequency de-innervation of the nerve supply to cervical and
lumbar facet joints is a an effective technique that can eliminate
pain for 8-12 months before needing to be repeated after nerve
branch regeneration. Any nerve branch that does not innervate skin
or muscle can be lesioned. Recently this technique has been used
successfully on hip and knee arthritis for patients too young or too
infirm to undergo joint replacement. It is also effective in cases of
patients with ongoing pain after joint replacement. The hip and
knee joints have multiple sources of innervation to many adjacent
blood vessels, or other vital anatomic structures. Only 2 anterior
nerve branches to the hip and 4 anterior branches to the knee are
amenable to RFA.
These partial neurotomies will not eliminate all the pain, but can
relieve 50-75% for up to 8 months. A test block is first performed
with 1cc local anesthetic to each branch, to make sure that there is
enough pain relief to warrant radiofrequency. The nerve branches
are targeted just before entering the joint. For treatment of severe
hip pain the femoral nerve branch (or branches) at the 12:00 position
on the superior acetabular rim and the articular branch of the
obturator nerve running laterally from the obturator foramen across
the proximal ischial ramus are accessible for RFA. The superomedial
and superolateral geniculate nerves located at the junction of the
epiphysis and metaphysis of the femur, and the inferomedial nerve
located at the junction of the epiphysis and metaphysis of the tibia,
are potential targets for RFA in treatment of chronic severe knee
pain.
MINIMALLY INVASIVE
LUMBAR DECOMPRESSION
The minimally invasive lumbar decompression (MILD) procedure
is approved by Medicare for spinal stenosis in patients who are
66 years of age with a ligament flavum thickness of 2.5mm or
greater. They must have classic neurogenic claudication, which
encompasses leg pain that progressively worsens with walking
but is relieved by sitting or bending forward. The procedure is
performed under conscious sedation or MAC anesthesia, thereby
avoiding general anesthesia. It involves local anesthesia, a stab
incision, a 5mm port to contact the lower lamina, and a bone
rongeur to remove some of the lower lamina. The port is then
advanced to the upper lamina. Next, some of the upper lamina is
also removed. An epidurogram is performed as a safety margin. A
tissue grasper is placed through the port to remove ligamentum
flavum. The epidural contrast is the margin of safety as the forceps
are never placed anterior to this line.
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PERCUTANEOUS DISK DECOMPRESSION
To reduce protrusions and small herniations causing radicular
pain there are numerous methods with needle-based approaches
that are similar to performing a discogram. These are seldom
performed because of lack of insurance coverage. The procedures
are performed under conscious sedation and do not cause epidural
bleeding or adhesions. Endoscopic discectomy with continuous
visualization, usually performed by orthopedic or neurosurgeons,
is generally covered by insurance. The procedure involves general
anesthesia and an incision to place the scope down to the disk level.
REGENERATIVE MEDICINE
Platelet rich plasma is a procedure where blood is taken from the
patients and spun to obtain the platelet rich fraction. Platelets
contain growth factors and interleukins which stimulate fibroblasts
and nearby stem cells, thus promoting tissue regeneration and
wound repair. Stem cells can be harvested from patient’s bone
marrow, spun and isolated, and injected typically into hip and
knee joints to regenerate cartilage and synovium. They can also
be injected into intervertebral disks. This is usually for discogenic
pain in young patients with small tears and preserved disk height.
In these cases fibrin glue is injected at the same time into the
disk annular tears. It is uncertain whether disk nuclear cells are
regenerated, but some before and after MRI’s have suggested this.
Since there is no insurance coverage for this kind of treatment
these techniques are popular among professional athletes and other
patients who can afford them. There are many early phase studies
of regenerative medicine techniques, some pending FDA approval.
Insurance coverage is by no means guaranteed, since insurance
companies rarely cover quality of life procedures. n