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ab
a
c
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J. Weil
b
Fig. 14.1 Symplicity Spyral™ multi-electrode renal denervation catheter electrode conguration (a, by courtesy of Medtronic, Inc.). The
electrodes are deployed into a spiral (helical) shape by partially retracting the guidewire proximal to the spiral section of the catheter. The
treatment length (the distance between electrodes 1 and 4) of the cath-
Table 14.1
distance between electrodes 1 and 4 as a function
of deployed diameter of the SPYRAL™ catheter
Treatment length according to the
Vessel diameter (mm) Treatment length (mm)
3 21
4 20
5 20
6 19
7 18
8 17
d
eter changes with the vessel diameter. 1–4 mark the electrode from distal [1] to proximal [4]. Straightening tool used over the distal portion of
the catheter (b, by courtesy of Medtronic, Inc.). Guidewire inserted (c)
beyond the distal tip (spiral not deployed). Guidewire retracted (d)
proximal to the proximal most electrode (spiral deployed)
Fig. 14.2 In the READY state (a), the “D” icon indicates the most
distal channel on the four-channel catheter. The icon is shaded green
when selected or shaded gray when deselected as shown here for channel 2. The text on the bottom displays the current status of the RF delivery. In the RF ON state (b) the current status of the RF delivery is
documented. Icons display the temperature value (blue) in degrees
Celsius and the impedance drop (white) from the baseline temperature
or impedance value, respectively. The arrow shows if the impedance
has decreased, stayed the same or increased from the baseline
impedance

14 Symplicity SPYRAL™: Device andProcedural Tips andTricks
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Patient Preparation
The patient is prepared using standard techniques for electrosurgery and catheterization. Ensure the patient’s entire body,
including extremities, is insulated from contact with
grounded metal parts. The dispersive electrode should be
placed on the thigh or any other nonbony area of the body
and should be outside the angiographic eld of view. Failure
to achieve good skin contact by the entire adhesive surface of
the dispersive electrode may result in a burn or high impedance measurements. Intravenous (IV) access for drug administration should be established and maintained throughout
the entire procedure. After inserting the introducer sheath
appropriate systemic anticoagulation (e.g. Heparin 80IE/kg)
is given to the patient aiming for an activated clotting time
(ACT) of at least 250seconds.
Since the patient will experience some visceral pain during ablation, analgesic and sedative medications are administered at least 5 minutes prior to ablation. Vital signs
including oxygen saturation need to be monitored throughout the procedure. Typically, intravenous midazolam and
fentanyl are used (incremental administration of up to or
4 mg and 150 mcg, respectively). Antiemetics (e.g. 4 mg
intravenous odansetron) may be used to prevent opioidassociated nausea. Due to their short half-life, we prefer the
use of remifentanil (0.025–0.1 mcg/kg/min as continuous
infusion) and propofol (0.5–1mg/kg IV loading dose; may
repeat by 0.5-mg/kg increments q3-5min). An infusion can
be started at 20mcg/kg/hour) titrated according to the clinical effect. As a rule, these patients do not need prolonged
monitoring, even after extensive procedures. Intravenous
atropine (1mg) should be available in case of a vagal reaction (due to RDN associated pain) as well as umazenil and
naloxone to reverse benzodiazepine and opioid actions in
case of clinical signicant respiratory depression.
Catheter Placement
Prepare the patient for catheter placement using standard
interventional techniques. Connect the Tuohy-Borst adapter
to the guide catheter and the stopcock sidearm to the TuohyBorst adapter. Under uoroscopy, inject contrast in both
renal arteries to assess anatomy. The renal arteries usually
originate from the lateral segment of the abdominal aorta at
the level of the rst and second lumbar intervertebral disc
space, right below the origin of the superior mesenteric
artery [3]. The right renal artery often arises more cranial.
The majority of renal arteries have an inferior take-off and
the conguration of an internal mammary catheter (IMA) is
most suitable for selective engagement. For renal arteries
with a horizontal take-off, a double curve guide (RDC) cath-
eter or a Judkins right (JR 1 or 2) may be well suitable. A
multipurpose catheter may provide optimal alignment in
renal arteries with a superior take-off. In general, before
reaching the hilum of the kidney, the main renal artery
divides into two or more branches (segmental arteries).
Ablation beyond the proximal main renal artery (Y-pattern),
including the primary branches allowing a greater number of
lesions is safe, and results in a signicantly greater decrease
in mean 24-hour ambulatory systolic and diastolic blood
pressure compared to the conventional approach [4]. Each
renal artery usually supplies small branches to the adrenal
gland, ureter and surrounding cellular tissue and muscles.
However, these branches should be avoided and not damaged
by ablation.
Cholesterol embolism is an infrequent but serious complication of renal artery angiography. It may be avoided by
minimizing contact between the guide catheter and the atherosclerotic aorta. Therefore, in the presence of severe atherosclerotic disease of the abdominal aorta guide catheter
engagement should optimally be performed by the “no
touch” technique [5]. In this case, the 0.035-inch J-wire
remains in the thoracic aorta while directing the tip of the
guide towards the ostium of the renal artery. Position of the
catheter is conrmed by small injections of contrast media.
Once the guide-tip is in the correct position, the 0.035 wire
will be carefully withdrawn allowing the catheter to passively to engage the ostium of the vessel. Optimal guide
position is important prior to insertion of any further equipment. The guide catheter tip should protrude 3–4mm into
the renal artery. The ablation catheter typically straightens
the guiding catheter slightly and may lead to disengagement.
If engagement and stability of the guide catheter proves challenging, consideration may be given to advancing a “buddy
wire” [6] carefully into the renal artery (Fig.14.3) or using a
guide catheter extension (Guidezilla™ or GuideLiner V3™,
inner diameter 0.057 and 0.056 inch, respectively) gently
advanced in a telescoping fashion (“mother and child”
concept).
Selective angiography is performed using 5–10cc of contrast. It is important to allow prolonged cine-angiographic
imaging for visualization of the contrast nephrogram. This
facilitates the detection of accessory renal arteries which also
can be treated by RDN, provided the vessel diameter is >3mm
(Fig.14.4). The risk of contrast-induced nephropathy is minimized by using as little contrast as possible. After angiography
it needs to be determine whether the arteries are suitable for
treatment. Exclusion criteria are summarized in Table14.2. In
patients with renal impairment or severe allergic reactions to
contrast agents, carbon dioxide (CO2) can be used as an alternative contrast agent (Fig.14.5) for RDN [7]. After visualization of the right and left renal artery there should be a
team-time-out to determine the ablation strategy.

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J. Weil
Once the guidewire has exited the rapid-exchange port, the
catheter is advanced over the guidewire through the guide
catheter. To reduce risk of arterial spasm nitroglycerine
(100–200mg) is given prior to advancing the catheter into
the artery. When all four electrodes exit the guide catheter,
the impedance monitoring screen (Fig.14.6) will then be displayed. If the display does not continue to the impedance
monitoring screen, follow these steps: (1) Check catheter
position and ensure that all 4 electrodes are outside of the
guide catheter. (2) Verify appropriate dispersive electrode
connection and contact with patient. If the previous steps do
not result in the display of the impedance monitoring screen,
b
(3) try moving the dispersive electrode to the patient’s ank.
If needed, replace the dispersive electrode.
Under uoroscopic guidance, advance the ablation catheter until the proximal electrode is located in the renal artery.
Branches outside the renal parenchyma with a diameter>3mm can also be treated. Under uoroscopic guidance,
the spiral is deployed by retracting the guidewire into the
device (Fig.14.1c, d) until the guidewire tip is well proximal
to electrode 4. However, make sure the guidewire does not
completely exit the rapid exchange port. Adequate wall contact is assessed angiographically after deployment of the
c
SPYRAL™ catheter and impedance values (approx. 250
Ohm) at each electrode should remain stable throughout at
least one respiratory cycle. If the starting impedance varies
by more than 10–20 Ohm, the catheter tip is not stable and its
position should be modied. To do so, slightly torque the
catheter clockwise and/or slightly move the catheter forward.
These small maneuvers should improve electrode apposition
against the vessel wall. If any electrode deploys in an unsuitable location (such as the ostium of a small vessel, a bifurcation or an adrenal gland artery), these electrodes can be
Fig. 14.3 The buddy wire technique, i.e., using an additional 0.014inch coronary guidewire along with the one being used to advance
SPYRAL™ catheter help to accomplish otherwise challenging anatomy. (a) showing an unstable guide catheter position. (b) Additional
coronary guidewire in a side branch of the right renal artery to stabilize
the tip of the guiding catheter, allowing advancement of the SPYRAL™.
(c) Guide wires are retracted before RF ablation
deselected by pressing the electrode number button on the
remote control or on the generator touch screen (Fig.14.2a).
By deselecting these individual electrodes, RF energy will
not be delivered to these electrodes when RF is activated.
Once electrodes are well apposed angiographically and
impedance values and tracings are stable, RF energy can be
delivered to the treatment site. This is ensured by pressing
any of the following: (1) the foot switch, (2) the RF button on
A 0.36-mm (0.014-in) guidewire is advanced into the target vessel. It is recommended to use only guidewires with a
exible soft distal tip without hydrophilic coating to avoid
kidney perforation. Prior to use, do not ush the SPYRAL™
catheter lumen or the catheter while in the hoop. Do not wipe
the spiral section of the catheter. Carefully insert the proximal end of the guidewire through the tip of the catheter.
Continue to pass the guidewire through the catheter until the
guidewire exits through the rapid exchange proximal port.
This exit port is located 30cm proximal to tip of the catheter.
the remote control, or (3) the RF button on the generator
front panel. The generator delivers power for a target duration
of 60s using an automated algorithm and will cease power
delivery upon completion of the treatment cycle. The timer
begins counting up and the LED indicator remains blue
while RF therapy is being delivered. At any point during the
60-sec. Treatment cycle, delivery of RF energy can be
stopped by depressing the foot switch, pressing the RF button on the generator front panel, or pressing the RF button on
the remote control.

ac
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145
Fig. 14.4 Selective angiography performed using 5–10cc of contrast.
(a) It is important to allow prolonged cine-angiographic imaging for
visualization of the contrast nephrogram. Please note “missing” tissue
Table 14.2
Major exclusion criteria
Severe renal impairment
Signicant atherosclerotic disease or stenosis
Signicant bro muscular dysplasia (FMD)
Previous renal artery intervention
Renal artery anatomy that precluded treatment (dened as <4mm
diameter)
Type 1 diabetes mellitus
Pregnancy
Exclusion criteria for renal denervation
(arrows) at the lower pole of the left kidney. (b) Accessory renal artery
supplying the lower pole of the left kidney
If the generator stops delivering RF energy to one or more
electrode(s) prior to reaching the 60-second treatment duration, an additional RF application may be performed from
the electrode(s) that did not complete treatment, at the same
location. However, rst visualize the artery to ensure that it
is safe to perform a repeated ablation at the same site, second
deselect electrodes that completed a 60-second cycle. If
needed, perform a slight adjustment to the catheter to warrant proper wall contact, then initiate ablation again.
Guarantee that the guide catheter is ushed with heparinized

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J. Weil
a
b
Fig. 14.5 Carbon dioxide angiography showing the right renal artery
in a 65-year-old patient with severe allergic reaction to contrast dye. A
negative contrast agent (carbon dioxide) is used for the diagnostic study
(a) in patients with impaired renal function or severe allergic reaction to
the iodinated contrast load and possible nephrotoxicity or allergic
shock, respectively. (b) Showing the position of the SPYRAL™ catheter during uoroscopy
saline periodically. Whenever ushing the guide catheter,
however, wait at least 3–5seconds to permit the temperature
and impedance measurements to become constant before initiating the next treatment cycle.
If multiple ablations are to be performed in one artery,
move the catheter proximally by pulling it back while taking
care to avoid diseased or calcied areas of the vessel
(Fig.14.7), by advancing the guidewire carefully out the tip
of the catheter to straighten the spiral distal end. A slight
clockwise rotation while pulling back can be applied to ease
the motion. In general, all treatments should be located at
least 5mm proximal to any prior treatment location. In case
of guiding instability, a buddy wire technique can be used to
position the SPYRAL™ catheter. However, the extra wire
should always be removed prior to ablation. Once the treatment is completed on one side, take an image of the artery,
then advance the guidewire carefully out the tip of the catheter to straighten the spiral distal end. Retract the straightened catheter into the guide catheter. If treating another
vessel, reposition the guide catheter within the next vessel.
Repeat the procedure for positioning the catheter and delivering treatments.
Luminal irregularities and or spasms (“notches”) after
ablations are common (Fig.14.8). According to histological
evaluation of renal arteries, luminal changes likely correspond to vessel wall edema, endothelial denudation and
adherent thrombotic material [8]. Occasionally, spasm may
improve with the use of vasodilators. More likely vasodilators will not improve the angiographic appearance (Fig.14.9).
Usually, the changes will invariably resolve during the next
days as been shown previously (with the rare exception of
development of renal artery stenosis) [9]. Therefore, it is
important not to perform balloon angioplasty or stenting in
the effected vessel. Once the treatment is completed on one
side, take an image of the artery, then advance the guidewire
carefully out the tip of the catheter to straighten the spiral
distal end.

cd
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a b
147
Fig. 14.6 Display of front touch screen (a) with electrodes partly within the guide catheter (b). The impedance monitoring screen will be dis-
played (c) when all four electrodes exit the guide catheter (d). Images by courtesy of Medtronic, Inc
Fig. 14.7 Areas which should be avoided and are major exclusion criteria for RDN. (a) Fibromuscular dysplasia (FMD) of the renal artery in
52-year-old women. (b) Signicant left renal stenosis in a 65-year-old man with known coronary artery disease

148
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Fig. 14.8 angiogram of the right renal artery before (a) and after (b) renal denervation of the main branch. Please note the notches (arrows) after
RDN
J. Weil
a
Dicult Anatomy
Tortuosity of the iliac artery and/or abdominal aorta are seen
frequently, especially in older patients. Severe tortuosity
may not allow to advance the guiding catheter or cause friction within the guide catheter so that advancement of the
renal denervation catheter into the renal artery may not be
possible. In this situation a long (e.g., 45cm) sheath can be
used to straighten the vasculature to allow positioning of the
guiding catheter and diminish friction. Alternatively, brachial access may be considered. However, care should be
taken to puncture the brachial artery successfully on the rst
b
attempt. Given the smaller space in the arm, uncontrolled
hematoma formation here can readily cause compression
syndrome with ischemia of the forearm and hand.
If the renal artery has an acute angle inferior take-off,
guide catheter engagement and support may be suboptimal
causing the guide to back out upon renal denervation catheter advancement. In this case, insertion of an 0.014-inch
buddy wire into the distal renal artery may offer more support and a stable guide catheter position (Fig.14.3). Again, it
is important to remember to remove the buddy wire during
ablation.
Fig. 14.9 Angiogram of a left lower accessory renal artery before (a)
and after RDN (b) showing spasms in the distal part and the proximal
part of the vessel which has not be ablated (arrows)

14 Symplicity SPYRAL™: Device andProcedural Tips andTricks
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Safety
No major adverse events (including all-cause death, major
cardiovascular events, peri-procedural complications, signicant renal impairment, or hypotensive/hypertensive crisis) were reported in the active arm of any of the novel sham
control trials (SPYRAL HTN-ON MED, the SPYRAL
HTN-OFF MED) [10]. However, the results are rather short
term and the diagnostic imaging modality used to reassess
the renal artery at follow-up maybe inadequate. In this context, the poor sensitivity of ultrasound in detecting subclinical lesions in the renal arteries should be mentioned [11]. It
is well known that development of atherosclerotic lesions
after endothelial injury can progress slowly and may take
years to become clinically apparent. Renal artery stenosis
has been reported after RDN [9]. Thus, long-term safety data
are still needed.
Post-Procedure
Upon completion of all treatments and angiographic control
for any complications, the distal end of the ablation catheter
is straightened by advancing the guidewire and then withdrawn in its straightened conguration completely from the
guide catheter. The guide catheter is retracted into the sheath
according to local standards. The introducer sheath is
removed from the artery and hemostasis at the puncture site
is achieved by standard of care. Hemostasis of arterial
puncture sites is still a critical point of vascular interventional. Vascular access site complication rate is approx. 5%
[12]. Endovascular vascular closure devices (e.g.
Angioseal™, St. Jude Medical, Minnetonka, MN, USA)
have been shown to be safe and effective in reducing the time
to hemostasis following angiographic or interventional procedures [13]. At our institution, a femoral arteriotomy closure device is used regularly to achieve immediate
post-procedure hemostasis. Every patient should, if not contraindicated, receive an antiplatelet drug (e.g. aspirin 100mg
qd) for 4weeks to avoid local thrombosis at the ablation site.
In summary, renal denervation represents a signicant
progress in the treatment of difcult to treat hypertension.
Renal denervation using the Simplicity SPYRAL™ catheter
is a straightforward procedure, which is well tolerated and
safe. However, given the fact that there is yet no intraprocedural control of ablation success, interventionalists have to
be aware about the anatomy and imaging of the renal arteries, the distribution of renal sympathetic nerves, the equipment necessary, and the procedural details in order to
enhance the success and decrease potential complications.
Therefore, RDN should be performed by physicians with
comprehensive capability in catheterization and endovascular techniques.
References
1. Liang B, Zhao YX, Gu N.Renal denervation for resistant hypertension: where do we stand? Curr Hypertens Rep. 2020;22:83.
2. Versaci F, Sciarretta S, Scappaticci M, Calcagno S, di Pietro
R, Sbandi F, Dei Giudici A, Del Prete A, de Angelis S, BiondiZoccai G.Renal arteries denervation with second generation systems: a remedy for resistant hypertension? Eur Heart J Suppl.
2020;22(Suppl L):L160–5.
3. Turba UC, Uacker R, Bozlar U, Hagspiel KD.Normal renal arterial anatomy assessed by multidetector CT angiography: are there
differences between men and women? Clin Anat. 2009;22:236–42.
4. Petrov I, Tasheva I, Garvanski I, Stankov Z, Simova I.Comparison
of standard renal denervation procedure versus novel distal and
branch vessel procedure with brachial arterial access. Cardiovasc
Revasc Med. 2019;20:38–42.
5. Feldman RL, Wargovich TJ, Bittl JA. No-touch technique for
reducing aortic wall trauma during renal artery stenting. Catheter
Cardiovasc Interv. 1999;46:245–8.
6. Selig MB.Lesion protection during xed-wire balloon angioplasty:
use of the “buddy wire” technique and access catheters. Catheter
Cardiovasc Diagn. 1992;25:331–5.
7. Renton M, Hameed MA, Dasgupta I, Hoey ET, Freedman
J, Ganeshan A. The use of carbon dioxide angiography for
renal sympathetic denervation: a technical report. Br J Radiol.
2016;89:20160311.
8. Templin C, Jaguszewski M, Ghadri JR, Sudano I, Gaehwiler R,
Hellermann JP, Schoenenberger-Berzins R, Landmesser U, Erne P,
Noll G, Lüscher TF.Vascular lesions induced by renal nerve ablation as assessed by optical coherence tomography: pre- and postprocedural comparison with the simplicity catheter system and the
EnligHTN multi-electrode renal denervation catheter. Eur Heart J.
2013;34:2141–8.
9. Kaltenbach B, Id D, Franke JC, Sievert H, Hennersdorf M, Maier J,
Bertog SC.Renal artery stenosis after renal sympathetic denervation. J Am Coll Cardiol. 2012;60:2694–5.
10. Stavropoulos K, Patoulias D, Imprialos K, Doumas M, Katsimardou
A, Dimitriadis K, Tsious C, Papademetriou V.Efcacy and safety
of renal denervation for the management of arterial hypertension:
a systematic review and meta-analysis of randomized, shamcontrolled, catheter-based trials. J Clin Hypertens (Greenwich).
2020;22:572–84.
11. Harvin HJ, Verma N, Nikolaidis P, Michael Hanley M, Dogra VS,
Goldfarb S, Gore JL, Savage SJ, Steigner ML, Strax R, Taffel MT,
Wong-You-Cheong JJ, Yoo DC, Remer RM, Dill KE, Lockhart
ME.Expert panels on urologic imaging and vascular imaging. ACR
appropriateness criteria® renovascular hypertension. J Am Coll
Radiol. 2017;14:S540–9.
12. Sesana M, Vaghetti M, Albiero R, Corvaja N, Martini G, Sivieri
G, Colombo A.Effectiveness and complications of vascular access
closure devices after interventional procedures. J Invasive Cardiol.
2000;12:395–9.
13. Kussmaul WG 3rd, Buchbinder M, Whitlow PL, Aker UT, Heuser
RR, King SB, Kent KM, Leon MB, Kolansky DM, Sandaz JG Jr.
Rapid arterial haemostasis and decreased access site complications
after cardiac catheterisation and angioplasty. J Am Coll Cardiol.
1995;25:1685–92.

ReCor Medical Paradise™ System:
HydroCooling System
ATTACH ME NTA
https://t.me/medicina_free
Device andProcedural Tips andTricks
VictorZeijen andJoostDaemen
15
General System Characteristics
The Paradise™ System consists of two main components: a
single use Paradise™ Catheter, containing an ultrasound
energy source (transducer) (Fig. 15.1) and a portable
Paradise™ Generator, which powers the transducer
(Fig.15.2). The Paradise™ Catheter is introduced via femoral access under uoroscopic guidance and advanced into the
renal artery. Bilateral renal denervation (RDN) is achieved
by delivering ultrasound energy within each renal artery
(Fig.15.3).
The system differentiates itself by using a thermal ultrasound element positioned in a uid lled balloon that prevents direct tissue contact with the energy source in order to
lower the risk of arterial wall damage and thromboembolism.
By using circumferential energy delivery the device is less
likely to suffer from issues related to catheter positioning
and suboptimal wall contact. Moreover, with a need for only
two to three 7-s ablations per main artery, denervation can be
performed fast with minimal patient discomfort.
The Paradise™ System is currently CE-marked but is still
considered to be investigational in the United States of
America.
Sono Wave 360
Transducer
Non-compliant balloon with
Fig. 15.1 Individual Paradise™ catheter components (courtesy of
ReCor Medical, Inc)
™
™
Atraumatic tip
V. Zeijen · J. Daemen (*)
Department of Cardiology, Erasmus University Medical Center,
Rotterdam, The Netherlands
e-mail: v.zeijen@erasmusmc.nl; j.daemen@erasmusmc.nl
© The Author(s), under exclusive license to Springer Nature Switzerland AG 2023
R. R. Heuser et al. (eds.), Renal Denervation, https://doi.org/10.1007/978-3-031-38934-4_15
151

152
ATTACHMENT B
https://t.me/medicina_free
Fig. 15.2 Paradise™ Generator (courtesy
of ReCor Medical, Inc)
Fig. 15.3 Renal denervation
using the Paradise™
ultrasound system (courtesy
of ReCor Medical, Inc)
V. Zeijen and J. Daemen
1-6mm
targeted depth
Complete 360
energy emission
0-1mm kept cool by
HydroCooling
°
™
System
Scientic Evidence
The Paradise™ System was rst introduced for treatment of
hypertension in 2011in the open-label single-arm REDUCE
study (n = 15) [1]. This rst-in-man study showed a sustained decrease in ofce and home blood pressure (BP) comparable to radiofrequency therapy in patients with severe
hypertension [1]. In the process, the cooling ow rate within
the balloon was increased to reduce the risk of renal artery
stenosis.
To conrm the rst-in-man study results, efcacy and
safety were evaluated in the larger single-arm REALISE
(n = 20) and ACHIEVE (n = 96) studies [2, 3]. The
ACHIEVE study demonstrated a sustained signicant
decrease in ambulatory systolic BP of −7.5mmHg 1year
post RDN in therapy resistant hypertensive patients [3].
Both studies demonstrated a good safety prole for use of
the Paradise™ system with low major adverse event rates,
no procedure- related major adverse events and no renal
artery stenosis [2, 3].
Following these larger single-arm studies, the randomized
double-blind sham-controlled RADIANCE-HTN study was
designed to overcome possible confounding bias and placebo effect issues [4]. In this study the effect of ultrasound
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