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ESWT and In-line Ultrasound Imaging

Posted by Sunny Jacob - Bayshore on 6/04/02 at 08:50 (086240)

ESWT and In-Line Ultrasound
I will try to cover several messages from various individuals based on our knowledge in Lithotripsy and ESWT and the use of in-line ultrasound.
Lithotriptors are used to break kidney stones with high energy shockwave. This method was developed in Germany in the early 80s. All lithotriptors have an x-ray unit and an in-line ultrasound. The patient lies on the table and the x-ray locates the stone/stones. The shockwave head is pointed to the stone. Now the x-ray is off (to avoid prolonged x-ray exposure)and the in-line ultrasound is on during the approx. 45 minutes of treatment. When the patient moves the stone is out of the shock wave focus (this can be seen on the ultrasound screen) and the shockwave head is readjusted.
In Europe, ultrasound imaging as well as x-ray is part of the curriculum for all physicians. Of course, radiology specialists specialize in x-ray and ultrasound.
For lithotripsy in North America, only x-ray is used in the majority of the clinics and no inline ultrasound; the reason being most urologists are not trained in ultrasound. Result: kidney stone by lithotriptor repeat treatment cases are much higher in North America than in Europe. For those who wish to know more about this, there are numerous comparative studies and statistical information readily available.
ESWT was derived from Lithotripsy and most of the well known ESWT manufacturers are also lithotriptor manufacturers, e.g Dornier, Storz, Siemens, etc.
As in most cases the specific pain area is very small, all ESWT equipments of the above have a built-in inline ultrasound imaging to focus the shockwave to the pain area. Almost all scientific studies in ESWT (most are from Europe) are done by using in-line ultrasound, - not a separate ultrasound equipment.
It is only in U.S.A. when Orbasone and a few other manufacturers started marketing ESWT equipment telling users that ultrasound in-line imaging was not necessary because they had to depend on ultrasound components from other manufacturers. Another explanation was they have a larger focal area. A large focal area is less effective than a small focal point for the treatment of tendinopathy. The focal point is approx. the size of a corn of rice.
So it is not a marketing tool as some have described for Dornier, Siemens, Wolf, etc, because they always saw the importance of in-line ultrasound imaging in ESWT to treat small focal area.
Of course one can do ESWT without ultrasound imaging. The difference will be in success rate. Dr. Z. has experience in both. Though he may not have done a scientific study I am certain he could tell the difference in success rate.
Bayshore does not endorse any manufacturer. We concentrate on our treatment protocol and use the best equipment on the market at a given time. Most of the internationally reputable manufacturers do produce good ESWT equipment.
Our clinic that uses Ossatron does not have ultrasound imaging. We use Ossatron mainly for non-union and stress fracture treatment. The Bayshore ESWT clinic for tendinopathy uses in-line ultrasound imaging for ESWT.

Re: ESWT and In-line Ultrasound Imaging

john h on 6/04/02 at 10:18 (086251)

Sunny: When a patient comes to you with PF and a stated pain level of lets say 6 what is your goal in pain reduction level. Seems I have read or heard that a 50% reduction in pain level is considered a success. When various providers of ESWT report success rates what are they considering a success? Is there some standard of measurement for success used by most or is each provider left to their own standards of success?

Re: ESWT and In-line Ultrasound Imaging

Sunny Jacob - Bayshore on 6/04/02 at 12:54 (086266)

At Bayshore we base the pain level on VAS (Visual Analog Scale) of 1 to 10, with 10 being the maximum pain. Most patients we treat arrive with a scale average of level 8 at activity and 6 at rest. The VAS scale is a subjective scale of measurement.
What we at Bayshore consider 'success' is a pain level of 3, or below 3 at activity, approximately 6 to 12 weeks after the treatment. I was told that some clinics may consider a pain level below 5 a successful outcome.
We had patients with 15 and 25 years of chronic shoulder tendonitis who became 100% pain free (from level 8 to 0) who received treatment three years ago.
Many times it depends on the length of the patient's chronic situation. The patients we accept should have a minimum 6 months chronic pain and should have undergone first line of treatments.
We also had patients (approx. 12%) who achieved only a slight change in their pain level, i.e. 1 to 2 levels below their pain level prior to ESWT, and approx. 3% experienced no change at all. We cannot explain the reason for these differences.
The above results are from Bayshore's treatment data since 1999.
European scientific studies (random accessed double blind) have shown an ESWT success rate of 72% for tendinopathy. Finally, ESWT is not a magic bullet or snake oil.

Re: ESWT and In-line Ultrasound Imaging

Ed Davis, DPM on 6/04/02 at 19:13 (086299)

I have asked David Lowy of the Sonorex Center in Vancouver, BC for his opinion on this. He is out of town for a few days but hopefully he will post here. The Siemen's unit does not include inline ultrasound and has a relatively small treatment head.

Keep in mind that most of the tedninopathies we are treating involve very superficial, easily identified structures so the process of aiming is very simple. Lithotripsy involves going in after deeper things (stones). The Siemen's unit is looking to obtain FDA approval for lateral epicondylitis as opposed to PF. This, too, is a superificial, easily found structure.

There are tendinopathies involving deeper structures where the aiming issue could make a difference. I have been trying to come up with some examples but perhaps areas of the rotator cuff of the shoulder. A unit with ultrasound imaging would offer the flexibility for use on such structures once the indications have been approved. One reason that the manufacturers may not have moved formward with this across the board is the limited number of FDA indications currently and on the horizon.

Siemens, to the best of my knowledge, is also a diagnostic ultrasound manufacturer so inclusion of an 'in-house' ultrasound product in their ESWT units is an option. Considering the relatively low cost of diagnostic ultrasound, cost would not be a prohibitive factor.
Ed

Re: ESWT and In-line Ultrasound Imaging

DR Zuckerman on 6/04/02 at 19:30 (086303)

Good post Ed. I believe the Siemen delivers it energy from the bottom and therefore inline ultrasound may not be needed. When you deliver from the side you need inline ultrsound. When you deliver high energy ESWT you have no pain with the side deliverance , but when you diliver from the bottom with high energy you may hit bone and cause pain and addtional short term trauma.

I really like the inlline ultrasound because you can place an energy pulse eactly where you want it . Is this important, from a logical point of view yes. Are there scientiful studies I am not sure as of yet. I will keep you informed as to what I learn .

I obtain many many cures with the orbie and that had no inline ultrasound.

What may be very important in the sucess of ESWT treatment is the size of the cigar shaped shockwave and the amount of pressure delivered by the shockwave.

Re: ESWT and In-line Ultrasound Imaging

Ed Davis, DPM on 6/04/02 at 22:17 (086324)

Thank you.

I have been bringing this up as an issue because several posters have expressed concern that their ESWT treatment would not be effective without ultrasound and other posters seemed to feed that concern with misinformation. This is a new modality which is still somewhat hard to obtain. This is not the time for patients to fret over unresolved issues such as high energy vs. low energy, ultrasound vs. no ultrasound. We will all be glad when more units of all types are available and the insurance industry recognizes and covers ESWT on a regular basis. It will take several years to sort out issues of efficacy between manufacturers, protocols and such. Lets not place this burden on patients now.
Ed

Re: ESWT and In-line Ultrasound Imaging - Not necessary

David L on 6/05/02 at 15:02 (086387)

I have been asked to give my opinion regarding inline ultrasound. My experience only relates to the Sonocur and the reasons that inline ultrasound is absolutely not needed. We have seven clinics across Canada and none of the devices use ultrasound imaging. We chose the Siemens Sonocur for all of our locations because it has the ability to deliver lower energy levels than any other Health Canada approved device. Our Vancouver location alone has performed more than 7,000 treatments since opening in 1999. Studies for the Workers Compensation Board and the Royal Canadian Mounted Police have been done and success rates are more than satisfactory. These studies have been submitted for publication and I would be happy to provide you with further details once published.
Firstly, with regards to lithotripsy, imaging is required because you are targeting something specific that you want to break up....ie...the stone. With lower energy ESWT, you are targeting the point of MAXIMUM TENDERNESS. A heel spur is a prime example of the reason you do NOT want imaging when using low energy ESWT (it is required in high energy because of anesthesia).

When looking at a 'spur' on an image, the spur is viewed in the middle of the heel. Many people have a spur that causes them no pain, and many don't have a spur, yet have tremendous pf pain. As we have all suffered with heel spur/pf, most of us know that that the 'classic' maximum point of pain is on the inside (medial) portion of the bottom of the heel. It is this point that you want to target....the most painful point. You cannot 'see' pain on an ultrasound. Only by patient feedback can you e certain that you are on the point of maximum tenderness.

In short, we see no need for any type of imaging with our equipment and I am certain that as this technology becomes more widespread across Canada and the US, imaging will not be used as in my opinion imaging (when no anesthesia is used) reduces success because it reduces the clinical focusing involvment of the patient, which is paramount.

Re: ESWT and In-line Ultrasound Imaging - Not necessary

DR Zuckerman on 6/05/02 at 16:08 (086396)

Hi David

I agree that most of pain and problem with classic heel spur/plantar fascia pain is on the inside of the heel. Palpation is very important, along with ultrasound for the following reasons.

1. Ultrsound is an excellent device to evaluate hypertropic plantar fascia and it gives the operator the ability to evaluate the fluid which is an indication that this is damage before the ESWT treatment

2. Keeping the area that you are interested in focus can be difficult due to patient movement.

3. Yes you can use palpation to do the procedure but the use of an ultrasound help to remove the judgement calls that have to be made during
treatment.

In summary the best results from a techinical stand point combine palpation, experience and the use of inline ultrasound before, during the ESWT procedure.

Re: ESWT and In-line Ultrasound Imaging - Not necessary

David L on 6/05/02 at 16:45 (086402)

Dr. Z.
Agree with you on the palpation, experience, and ultrasound before as a diagnostic tool, however during treatment, it is imperative to refocus the shock head every 200-400 pulses to make certain you are 'on the spot'. It is the patient who is the only one that can tell you this, not the ultrasound or the tech.

BTW....did you see the April issue of Foot & Ankle International which had a meta-ananalysis on ESWT for pf. You can read the abstract at
http://www.aofas.org/fai/2304.asp#1
Regards,
David

Re: ESWT and In-line Ultrasound Imaging - Not necessary

Ed Davis, DPM on 6/05/02 at 16:55 (086406)

David:

Thank you for your prompt reply. I hope to send your info. packet to the medical director of Wasghington State Labor and Industries, our workers compensation carrier for consideration of coverage.

I think that the potential work relationship of plantar fasciitis is a 'hot' issue. ESWT would save the worker's comp. system a great deal of money over surgery, not to mention decreased time loss from work.

Thank you again for your comments concerning ultrasound. I use diagnostic ultrasound in my office. I can tell you that the areas of fascia that look the worst on ultrasound do not always correspond to the areas of maximum tenderness -- those areas may be missed if ultrasound was to be the primary targeting method. I think that ultrasound is a great adjunct but not a necessity for current indications.
Ed

Re: ESWT and In-line Ultrasound Imaging - Not necessary

DR Zuckerman on 6/05/02 at 21:16 (086451)

There is always going to be different ways to get the same results. At present I really like the inline ultrasound for delivering shockwaves at the insertion and around the insertion. What is the size of the shockwave for the sieman machine. The dornier is 5mm by 2cm.

Re: ESWT and In-line Ultrasound Imaging - Not necessary

john h on 6/06/02 at 09:39 (086501)

After 7 years the pain spot on both of my feet remains very constant and is at the classic spot of where the fascia attaches to the heel on the inside of the foot. The only thing that changes is sometimes it is more painful when I press on it than at other times. Seems to be about the size of a nickle. Certainly no larger.

Re: ESWT and In-line Ultrasound Imaging

john h on 6/04/02 at 10:18 (086251)

Sunny: When a patient comes to you with PF and a stated pain level of lets say 6 what is your goal in pain reduction level. Seems I have read or heard that a 50% reduction in pain level is considered a success. When various providers of ESWT report success rates what are they considering a success? Is there some standard of measurement for success used by most or is each provider left to their own standards of success?

Re: ESWT and In-line Ultrasound Imaging

Sunny Jacob - Bayshore on 6/04/02 at 12:54 (086266)

At Bayshore we base the pain level on VAS (Visual Analog Scale) of 1 to 10, with 10 being the maximum pain. Most patients we treat arrive with a scale average of level 8 at activity and 6 at rest. The VAS scale is a subjective scale of measurement.
What we at Bayshore consider 'success' is a pain level of 3, or below 3 at activity, approximately 6 to 12 weeks after the treatment. I was told that some clinics may consider a pain level below 5 a successful outcome.
We had patients with 15 and 25 years of chronic shoulder tendonitis who became 100% pain free (from level 8 to 0) who received treatment three years ago.
Many times it depends on the length of the patient's chronic situation. The patients we accept should have a minimum 6 months chronic pain and should have undergone first line of treatments.
We also had patients (approx. 12%) who achieved only a slight change in their pain level, i.e. 1 to 2 levels below their pain level prior to ESWT, and approx. 3% experienced no change at all. We cannot explain the reason for these differences.
The above results are from Bayshore's treatment data since 1999.
European scientific studies (random accessed double blind) have shown an ESWT success rate of 72% for tendinopathy. Finally, ESWT is not a magic bullet or snake oil.

Re: ESWT and In-line Ultrasound Imaging

Ed Davis, DPM on 6/04/02 at 19:13 (086299)

I have asked David Lowy of the Sonorex Center in Vancouver, BC for his opinion on this. He is out of town for a few days but hopefully he will post here. The Siemen's unit does not include inline ultrasound and has a relatively small treatment head.

Keep in mind that most of the tedninopathies we are treating involve very superficial, easily identified structures so the process of aiming is very simple. Lithotripsy involves going in after deeper things (stones). The Siemen's unit is looking to obtain FDA approval for lateral epicondylitis as opposed to PF. This, too, is a superificial, easily found structure.

There are tendinopathies involving deeper structures where the aiming issue could make a difference. I have been trying to come up with some examples but perhaps areas of the rotator cuff of the shoulder. A unit with ultrasound imaging would offer the flexibility for use on such structures once the indications have been approved. One reason that the manufacturers may not have moved formward with this across the board is the limited number of FDA indications currently and on the horizon.

Siemens, to the best of my knowledge, is also a diagnostic ultrasound manufacturer so inclusion of an 'in-house' ultrasound product in their ESWT units is an option. Considering the relatively low cost of diagnostic ultrasound, cost would not be a prohibitive factor.
Ed

Re: ESWT and In-line Ultrasound Imaging

DR Zuckerman on 6/04/02 at 19:30 (086303)

Good post Ed. I believe the Siemen delivers it energy from the bottom and therefore inline ultrasound may not be needed. When you deliver from the side you need inline ultrsound. When you deliver high energy ESWT you have no pain with the side deliverance , but when you diliver from the bottom with high energy you may hit bone and cause pain and addtional short term trauma.

I really like the inlline ultrasound because you can place an energy pulse eactly where you want it . Is this important, from a logical point of view yes. Are there scientiful studies I am not sure as of yet. I will keep you informed as to what I learn .

I obtain many many cures with the orbie and that had no inline ultrasound.

What may be very important in the sucess of ESWT treatment is the size of the cigar shaped shockwave and the amount of pressure delivered by the shockwave.

Re: ESWT and In-line Ultrasound Imaging

Ed Davis, DPM on 6/04/02 at 22:17 (086324)

Thank you.

I have been bringing this up as an issue because several posters have expressed concern that their ESWT treatment would not be effective without ultrasound and other posters seemed to feed that concern with misinformation. This is a new modality which is still somewhat hard to obtain. This is not the time for patients to fret over unresolved issues such as high energy vs. low energy, ultrasound vs. no ultrasound. We will all be glad when more units of all types are available and the insurance industry recognizes and covers ESWT on a regular basis. It will take several years to sort out issues of efficacy between manufacturers, protocols and such. Lets not place this burden on patients now.
Ed

Re: ESWT and In-line Ultrasound Imaging - Not necessary

David L on 6/05/02 at 15:02 (086387)

I have been asked to give my opinion regarding inline ultrasound. My experience only relates to the Sonocur and the reasons that inline ultrasound is absolutely not needed. We have seven clinics across Canada and none of the devices use ultrasound imaging. We chose the Siemens Sonocur for all of our locations because it has the ability to deliver lower energy levels than any other Health Canada approved device. Our Vancouver location alone has performed more than 7,000 treatments since opening in 1999. Studies for the Workers Compensation Board and the Royal Canadian Mounted Police have been done and success rates are more than satisfactory. These studies have been submitted for publication and I would be happy to provide you with further details once published.
Firstly, with regards to lithotripsy, imaging is required because you are targeting something specific that you want to break up....ie...the stone. With lower energy ESWT, you are targeting the point of MAXIMUM TENDERNESS. A heel spur is a prime example of the reason you do NOT want imaging when using low energy ESWT (it is required in high energy because of anesthesia).

When looking at a 'spur' on an image, the spur is viewed in the middle of the heel. Many people have a spur that causes them no pain, and many don't have a spur, yet have tremendous pf pain. As we have all suffered with heel spur/pf, most of us know that that the 'classic' maximum point of pain is on the inside (medial) portion of the bottom of the heel. It is this point that you want to target....the most painful point. You cannot 'see' pain on an ultrasound. Only by patient feedback can you e certain that you are on the point of maximum tenderness.

In short, we see no need for any type of imaging with our equipment and I am certain that as this technology becomes more widespread across Canada and the US, imaging will not be used as in my opinion imaging (when no anesthesia is used) reduces success because it reduces the clinical focusing involvment of the patient, which is paramount.

Re: ESWT and In-line Ultrasound Imaging - Not necessary

DR Zuckerman on 6/05/02 at 16:08 (086396)

Hi David

I agree that most of pain and problem with classic heel spur/plantar fascia pain is on the inside of the heel. Palpation is very important, along with ultrasound for the following reasons.

1. Ultrsound is an excellent device to evaluate hypertropic plantar fascia and it gives the operator the ability to evaluate the fluid which is an indication that this is damage before the ESWT treatment

2. Keeping the area that you are interested in focus can be difficult due to patient movement.

3. Yes you can use palpation to do the procedure but the use of an ultrasound help to remove the judgement calls that have to be made during
treatment.

In summary the best results from a techinical stand point combine palpation, experience and the use of inline ultrasound before, during the ESWT procedure.

Re: ESWT and In-line Ultrasound Imaging - Not necessary

David L on 6/05/02 at 16:45 (086402)

Dr. Z.
Agree with you on the palpation, experience, and ultrasound before as a diagnostic tool, however during treatment, it is imperative to refocus the shock head every 200-400 pulses to make certain you are 'on the spot'. It is the patient who is the only one that can tell you this, not the ultrasound or the tech.

BTW....did you see the April issue of Foot & Ankle International which had a meta-ananalysis on ESWT for pf. You can read the abstract at
http://www.aofas.org/fai/2304.asp#1
Regards,
David

Re: ESWT and In-line Ultrasound Imaging - Not necessary

Ed Davis, DPM on 6/05/02 at 16:55 (086406)

David:

Thank you for your prompt reply. I hope to send your info. packet to the medical director of Wasghington State Labor and Industries, our workers compensation carrier for consideration of coverage.

I think that the potential work relationship of plantar fasciitis is a 'hot' issue. ESWT would save the worker's comp. system a great deal of money over surgery, not to mention decreased time loss from work.

Thank you again for your comments concerning ultrasound. I use diagnostic ultrasound in my office. I can tell you that the areas of fascia that look the worst on ultrasound do not always correspond to the areas of maximum tenderness -- those areas may be missed if ultrasound was to be the primary targeting method. I think that ultrasound is a great adjunct but not a necessity for current indications.
Ed

Re: ESWT and In-line Ultrasound Imaging - Not necessary

DR Zuckerman on 6/05/02 at 21:16 (086451)

There is always going to be different ways to get the same results. At present I really like the inline ultrasound for delivering shockwaves at the insertion and around the insertion. What is the size of the shockwave for the sieman machine. The dornier is 5mm by 2cm.

Re: ESWT and In-line Ultrasound Imaging - Not necessary

john h on 6/06/02 at 09:39 (086501)

After 7 years the pain spot on both of my feet remains very constant and is at the classic spot of where the fascia attaches to the heel on the inside of the foot. The only thing that changes is sometimes it is more painful when I press on it than at other times. Seems to be about the size of a nickle. Certainly no larger.