Training Certification course guide

SoftWaves™Training Guide
Pre-Treatment:
For pain indications, it is important to explain several items to the patient in
advance and for the technician to understand:
The average number of treatments for pain pathologies is between 2 and 3
treatments. The additional treatments usually target an expanded or additional
injury site not recognized during the first treatment. A patient can only sense
pain from the most painful spot for any single chronic injury. During the first
treatment this primary area is identified with exploratory pulses and the vast
majority of pulses are directed at this level. Additional treatments are typically
scheduled at weekly intervals; however, earlier or later treatments are also
beneficial. During second and additional treatments, the primary injury site is
usually much less painful. This site should be treated again with at least 500
pulses, but newer, adjoining, or related areas should be sought out and identified
with exploratory pulses. There are almost always secondary injury sites for any
given chronic injury.
Exploratory pulses are intended to identify the injury sites. You cannot move over
the potential injury sites too quickly. Oddly enough, sometimes it takes 10 plus
pulses in a location to initiate a pain response. A single pulse will not typically
cause a patient to respond with pain. Take your time and be thorough with these
exploratory pulses to get a clear picture of the painful sites. Mark these sites
down on an anatomical drawing to help locate the painful sites for additional
treatments if required.
SoftWaves™ offer a huge advantage as they cover a very broad area helping you
to easily locate and treat the pathologies. When you understand and accept that
the technology’s mechanism of action is a true biologic response, it is not hard to
accept that ultimately each location may only require one treatment if it is
thoroughly covered with adequate pulses. Additional treatments may be limited
to treating secondary and tertiary locations. Radial devices often require up to 12
treatments as they do not generate a biologic response as they do not create
sheering (negative) forces on the cell walls.

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The historical trend for treating pain pathologies with electrohydraulic waves
(true shockwaves) is with fewer treatments, lower energy, and fewer shocks for
better outcomes. Do not over treat the patients, as it is theoretically possible to
disrupt the initial biologic response with additional treatments. The vast majority
of treatments are not required for healing, but only to moderate pain in the
interim. Remember, the initial healing response (stem cells) last up to 12 weeks.
The inflammatory (pain reduction) response is nearly immediate and this is what
most patients recognize and appreciate in the short term. The inflammatory
response should not be confused with long term healing and remodeling.
Healthy tissue is not painful to treat. Only inflamed tissue is painful to treat. A
patient will give excellent feedback when you have located the actual injury site.
The operator should pulse (at a low frequency so as not to waste pulses) the
suspected injury site each treatment with exploratory pulses to identify all painful
areas. These areas should be marked on the patient or on a treatment form so
fewer pulses are wasted. The pulses should only be directed at the painful areas.
Any pulse that is not uncomfortable is a wasted pulse with the exception of
exploratory pulses to identify the injury sites. There is a huge correlation
between the level of pain during a treatment and outcomes. If the treatment is
painless there usually will be no benefit. The more painful the treatment the
better the outcome
It must be explained that there are two mechanisms of action for SoftWaves™.
First, SoftWaves™ reduce inflammation and swelling, oftentimes immediately
which leads to the immediate or near-term reduction of pain and swelling. The
effects of the first treatment can best be explained via a comparison to a deep
tissue massage. These massages are painful at times but result in an immediate
improvement. This first reduction in pain is not permanent healing. This
reduction in pain is due to managing the inflammatory system in the short term.
The second, more important mechanism of SoftWaves™ is that the pulses fool
the body into thinking that it has been injured. The waves cause the localized cell
walls to become permeable and pass proteins through the walls via exosomes
that mimic cellular injury. This stimulates the body to initiate a biologic cascade,
including the production of stem cell attractants, the recruitment of stem cells,
and the activation and differentiation of stem cells that leads to new and healthy
tissue. This “healing” takes place over 12 weeks from the last treatment.

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Additional treatments can be utilized to reduce pain and make a patient
comfortable over this 12-week healing cycle. Treatments in excess of 3 only help
manage short term pain and inflammation. These additional treatments do not
lead to statistically significantly higher success rates. Patients can return to
normal lifestyle immediately after treatment including light athletic workouts.
Gyms such as CrossFit should be avoided until the patient returns to health.
Whatever a doctor has prescribed in the past, such as stretching, and PT should
be continued.
The longer a patient has been injured, the more likely that there is a secondary or
tertiary injury site. Imagine favoring one heel (plantar fasciitis) for months. This
often requires a patient to change gait and not place weight on the affected heel.
This often leads to additional injuries in the Achilles, midfoot and even the mid-
calf. Ask the patients about these sites and briefly explore and mark these sites
with exploratory SoftWaves™. A patient will react with pain when you have
identified another injury site.
Think Biomechanics. For every muscle or pathology that is constricted over time,
another muscle has been over extended over the same timeframe and probably
has suffered some injury. Use common sense when evaluating a patient. During
the first treatment, a patient oftentimes does not even realize there are other
painful areas. Explore these obvious biomechanical links at the beginning of each
therapy session with exploratory, low frequency SoftWaves™.
If a patient does not get better after 12 weeks and after multiple treatments it is
because you did not treat the correct area/areas or undertreated the area.
Although there are very few contraindications, explain them in detail to the
patient. Some important reminders: the lungs and esophagus should be avoided
as they contain air. SoftWaves™ release their remaining energy when they enter
air from tissue, and this could cause bruising. Bruising could be harmful in the
esophagus and lungs. When treating the shoulders or back, be aware if a patient
starts coughing, or has a tickling feeling in their throat; change the location and
direction of the SoftWaves™ probe.
It is best that treatments only be directed to the extremities.

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Make certain a patient is seated or lying down during the treatment. There have
been a few reported incidences of a patient fainting during a treatment from
anxiety, increased pain, or even low blood pressure.
Very rarely, a patient will complain of increased pain after a treatment
(sometimes even severe pain). These rare cases have been explained in the past
by the patient having had recent multiple steroidal injections in the injury site. We
have only witnessed a handful of these cases over our ten-year history. Patients
should be questioned about steroidal injections prior to the first treatment and
warned of the potential response. These injections fool the smart response
initiated by the SoftWaves™. Wait at least 4 to 6 weeks after steroid injections
before applying ESWT (wash out). These injections mask the inflammatory levels
at the injury site and cause the SoftWaves™ to actually increase the inflammation
in the short term. This increased pain can be managed with OTC pain meds for
less than 24 hours and ultimately the site heals as normal.
Make certain a patient is not on pain medication during therapy as this may
prevent a correct diagnosis of the injury. Pain medications to avoid prior to
treatment include Advil, Motrin (Ibuprofen), Aleve (Naproxen Sodium), and
Ascriptin, Bayer, Ecotrin (Aspirin). Please avoid prescription NSAIDs including
Anaprox (Naproxen Sodium), Cambia, Cataflam (diclofenac potassium), Celebrex
(celecoxib), Clinoril (sulindac), Daypro (oxaprozin), Feldene (piroxicam), Indocin,
Tivorbex (indomethacin), Mobic, Vivlodex (meloxicam), Nalfon (fenoprofen),
Narprelan, Naprosyn (naproxen), Vimovo, Voltaren, Zorvolex (diclofenac,
diflunisal, etodolac, ketorolac tromethamine, meclofenamate, nabumetone,
salsalate
The treatment varies in pain level. The entire treatment lasts only a few minutes.
The pain is highest in the beginning and should moderate as the patient becomes
less inflamed and gets used to the treatment. Less than 1 in 1000 patients has
refused treatment after the initial pulse. Never start the treatment directly in the
most painful region. Always start delivering the first pulses before touching the
skin to get the patient used to the noise. The pain can be managed by starting
therapy at lower energy levels and starting on the margins of the injury and
working inward, slowly raising the energy levels to the therapeutic levels required
to initiate the biologic cascade (levels 10 or 11).

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Most patients have some immediate improvement although not everyone does.
Immediate improvement is a very good indicator of the ultimate success of the
therapy. It is very important to tell the patient to be careful to avoid overuse
shortly after ESWT because the immediate reduction of pain after ESWT does not
mean that the tissue has completely healed!!It is expected that at least 80% of
the patients to be 100% pain free at 12 weeks. This varies by indication.
See the complete list of contraindications in the operator’s manual. This Training
guide does not replace the operator’s manual. The manual should be read and
understood in full prior to treating any patients.
Treatment
Before the first treatment, it is important to pulse a patient’s hand so they can get
used to the sensation, including the light flashes and the noise. Many patients are
nervous at first and this "test pulse" helps to make them feel more comfortable.
Always clean the membrane with alcohol prior to and immediately after each
treatment. Follow all additional standards of care for disinfection at your facility.
Infections, open wounds, or abrasions must be covered with either a sterile drape
or disposable ultrasound probe cover, and sterile ultrasound gel.
You can never use too much ultrasound gel. Do not skimp. Constantly add gel or
move into place with the therapy head during treatment. Air is your enemy as
SoftWaves™ cannot propagate through air and release their energy in the
presence of air. If you overwork gel by movement, you add micro air bubbles in
path of the SoftWaves™. Air dramatically reduces the effect of SoftWaves™.
Even excess amounts of hair increase air and reduce effectiveness. Excessive hair
can be shaved in the target areas. Even thick calluses can reduce the
effectiveness (frequent on heel and midfoot). A pedicure in advance may be
required to remove calluses or excess dry skin.
Dirty water and filters increase the air levels in the pathway. Always exchange
water cartridges with each probe exchange to minimize both.

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Look for air bubbles in the membrane prior to the treatment. Work them out
with gravity and your hand. A SoftWaves™ sounds different as it passes through
air and you will quickly learn to identify this sound and to make adjustments.
Try to limit the number of treatment sites during any one therapeutic session. A
typical session, especially the first session, consist of identifying the most painful
area and focusing on it with at least 1500 pulses per area/joint. Only in rare cases
should more than 4000 pulses be delivered during any session.
The minimum therapeutic energy level is .08 mj/mm squared. This corresponds
to levels 8 through 13. Level 10 is the most utilized level known to generate a
biologic response (.1mj/mm) Lower levels can be used initially to limit the pain of
the patient. Get to the therapeutic level as quickly as possible to get the best
outcome…. yes, no pain, and no gain. If a patient does not recognize pain at level
11, increase the energy level until you locate the painful areas. Excessive tissue in
the path requires higher levels (hips or muscular arms for example).
You may be able to identify secondary injury sites during the second and third
treatments. Utilize about a third of the pulses on the initial pathology during the
second or third sessions in addition to treating the secondary site.
Refrain from relying on a patient’s predetermined diagnosis. The patients are
visiting us for a reason. The previous treatments DID NOT WORK. The probe is an
incredible diagnostic tool as it identifies inflammation/injuries via a painful
patient response. The vast majority of patients do not realize they have
alternative/additional injuries until we locate them with the probe. It is very
common for a patient to present insisting that they have had plantar fasciitis for
years only to discover the Achilles and calf are actually more inflamed. These
areas have never been treated before, and when treated the patients recover
quickly.
Over time as a patient continues to use an injured limb, inflammation builds up
and spreads. A tennis elbow after 6 months may affect nearly the entire arm. The
initial treatments reduce this broad inflammation, and only after several
treatments can you recognize the actual injury site.

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In extremely rare cases an analgesic may be required or requested. NEVER use a
local anesthetic as this is proven to reduce successful outcomes. If necessary
use a block only. Some people use freezing spray to reduce pain.
A maximum frequency of 4 pulses per second is suggested.
The pressure setting should be at the lowest level as this maximizes the amount
of energy that enters the body. To minimize pain for sensitive patients, you can
fill to higher levels to minimize pain (at the expense of outcomes however).
If a patient has not shown improvement after several sessions, try to identify
alternative injury sites and change parameters, increase or decrease energy or
change the frequency. It is rare that we cannot have a positive outcome.
Experienced patients can be trusted to hold the probe and to treat themselves.
This is quite beneficial as they can immediately identify the pain and they trust
themselves not to hurt themselves allowing for higher energy levels to be used.
Patients who are scared can also be encouraged to hold the probes as this
minimizes anxiety.
Constantly monitor the treatment as it can be quite boring and you may have
moved off the painful area, or not be making good contact. Any painless pulse is
a wasted pulse.
Ask patient frequently if you are on the most painful location. This may change
over the course of a treatment.

After Treatment
Note all of the patient treatment protocols including treated areas, number of
pulses, frequency, and range of energy levels. If possible maintain the database
to be provided by TRT. These databases can be used to learn ideal protocols over
time.
Remind patient to avoid extreme exercise.

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Remind patient that just like after a massage, they need to drink lots of water.
Remind patients that oftentimes patients are tired after SoftWaves™ treatment.
Avoid a long drive (as a driver) for instance after your treatment.
Remind patients that many report a tingling sensation in the treatment area for
several days after therapy. This is good.
Avoid anti-inflammatory medicine (as described above) for several days after
therapy as this may reduce outcomes.
Wait a full 12 weeks after your last treatment to evaluate outcomes as the
biologic response is active during this entire 12 weeks.
If an operator notices several consecutive patients do not have successful
outcomes, consult service as the device may be malfunctioning. You will learn to
differentiate good from bad pulses with your ears and with your hands.
Erectile Dysfunction/Peyronie’s Protocol Differences
Unlike pain pathology patients, the ED treatment should not be painful. Each
patient should be told to tell the SoftWaves™ Operator of any pain. The energy
level can be turned down, and any painful area avoided. If pain persists, the
treatment should be discontinued as the device has located a condition other
than ED.
Also, unlike any pain pathology, the patient and probe needs to be protected
from any potential cross contamination. There are several disposable ultrasound
probe covers, or large condoms, or other disposable covers that can be utilized.
First, apply a large amount of gel to the membrane of the probe after checking for
any air bubbles in the probe. Next, apply disposable cover, check for any
substantial air bubbles in gel, remove if necessary, and lock in place with a rubber
band if required. Finally, apply more gel to shaft of penis, the perineum, and to
the probe as well. Never skimp on the Gel. Air is your enemy.

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The typical treatment is 1500 – 2000 pulses. For the first treatment, try to use the
higher range of shocks. An equal number of pulses should be applied to the
penis, shaft, and the perineum, all along the base of the scrotum. The shaft
should be targeted laterally (from the side), all along the shaft, including targeting
the base of the shaft and below as well. The tip of the penis should be avoided as
this is sometimes painful. Also, avoid treating the urethra directly.
During the treatment, frequently ask the patient if there is any pain or discomfort
and adjust the therapy accordingly. This should not be painful.
The perineum should be targeted at a 45 degree angle up towards the shaft of the
penis as well.
After the treatment, the disposable probe cover should be removed, disposed of
properly, and the probe disinfected with alcohol or other disinfectant.
A total of 3 to 6 treatments are required, Improvement continues for 8 weeks
after the last treatment. Early symptom improvement can be seen as early as a
few weeks from the first treatment. One of the first signs of improvement for the
patient is morning erections. A minimum of 12 weeks from first treatment should
be reserved prior to final outcome evaluation.
The Peyronie's patient’s protocol should be adjusted such that half of the pulses
should be applied to the scar tissue associated with the condition from several
different angles. The balance of pulses should be applied to the shaft and
perineum if the patient also suffers from poor blood supply or ED.
Improvements are thought to last from 12 to 24 months based on recent
publications.