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To Elyse

Posted by Ralph on 7/01/05 at 14:43 (177661)

Good for you Elyse by now you recognize the fork in the path and which one not to go down.

I'm not an expert in ESWT but it's my understanding that the only machine FDA approved to treat Chronic Lateral Epicondylatis, which is commonly called tennis elbow, is the Ossation Machine.

Here is an article that states this. I just surfed the web and found it.

HealthTronics OssaTron Receives FDA Approval to Treat Chronic Lateral Epicondylitis - Tennis
2003-03-18 HealthTronics Surgical Services, Inc. announced that the US Food and Drug Administration has approved its high energy OssaTron(R) orthopaedic shock wave device for the treatment of chronic lateral epicondylitis (also known as tennis elbow).

The OssaTron is the only high-energy orthopaedic shock wave device approved for one time treatment of epicondylitis. The OssaTron already is approved for treatment of plantar fasciitis (heel pain) and now becomes the only such device approved for multiple indications.

The FDA approved the device based on the results of a 225 patient multi-center, randomized, placebo-controlled, double-blinded study. The comparison of results between active treatment patients and placebo-treated patients was highly significant according to the statistical analyses. In fact, 90% of treated patients received a benefit from the treatment and 64% had an excellent or good outcome.

Epicondylitis is most often associated with overuse of the arm in a wide variety of activities associated with work and play. Traditionally, the only alternative for patients who did not respond to conservative non-surgical treatment was an invasive surgical procedure. These procedures typically have extended recovery times and may be associated with significant complications and poor outcomes.

Now my interpetation(guess) of how a Podiatrist could provide treatment for this condition. Under current law in the U.S. I don't think that they can provide treatment unless under the supervision of an M.D. or D.O. who is licensed to treatment that part of the skelton. In addition they must be trained and certified to do so, but picture this. Say the Podiatrist is also a certified ESWT Tech. He/she is wearing two hats and working two jobs , one of a Podiatrist, the other of a certified ESWT Tech or simply a Pod that was trained in how to do ESWT on the Ossatron and happens to be an ESWT tech at the surgical center when he has time. I don't know of many Pods that have spare time, but picture that. Any Podiatrist certified to use the Ossatron would be considered a certified ESWT Tech.

Situation at hand, Ortho Doc. A has a patient with tennis elbow and wants that patient to have ESWT. Ortho Doc. A has two choices. He can send his patient to the Outpatient Surgical Center that has the Ossatron and he and the tech work together along with an anaestheologist if one is required provide the patients treatment, or if that center accepts the fact that the ESWT tech they employ has the necessary training to do the entire procedure themselves Ortho Doc A's patient could be treated at the center by the Tech alone with of course the anaestheologist if needed for this procedure.

My guess and it's strickly a guess is that Ortho Doc A is going to be on the scene for the treatment. At the cost of malpractice insurance I bet he shows up at the surgical center. Heck he want to be paid even if the tech administers the treatment.

Now imagine the Tech at that OutPatient Surgical Center just happens to be a Podiatrist. Bingo one could say that a Podiatrist is treating the elbow, but in reality that isn't how it would be seen. The tech who happens to also be a Pod in this case I think would more than likely be under the supervision of the attending Ortho Doc just an any other tech would be. I think how the treatment is delivered depends on the Ortho Doc, the Surgical Center's requirements and the certification of the tech and of course the help of anaesthologist if one is required.

I think what Dr. Zuckerman is imagineing for the future are centers where the more portable Dornier machines are set up or even the use of mobile units like his and Ortho doctors send their patients to these sites for their treatment or the mobile unit rolls up to the Orthos office. The ortho does the diagnosis and the 'ESWT center's tech' provides the treatment using the Dornier machine in 'off label usage'.

Doctors are permitted to use the machine to provide treatment that they think is beneficial to other areas of the body even though the machine may not have been FDA approved to treat that area. Pods must stick to treating the area of the body they are licensed by their state to treat. Right now I don't think they can legally treat an elbow or shoulder in any state in off label usage unless under the supervision of an Ortho, but I'm not certain. You'd have to check with the state. An Ortho on the other hand could use the machine off label to treat any part of the skeleton. They are not restricted to ankles and feet.

With law restrictions I think you'll find docs don't take chances when providing treatments. No one wants to risk their licenses.

Personally I think Doc's just want to treat patients. They want to make their pains go away. Each tries his/her best to do so with the training, medicine and machines available.

I think it's best to live in the present, not worry about the past, plan for the future, but don't fixate on problems that haven't happen yet.

Re: To Elyse

Elyse B on 7/01/05 at 15:09 (177667)

Ralph, thanks for the detailed explanation.

I am part of a huge running community in NYC and have never once heard of anyone having ESWT. Not that it has not been done I guess but I find it odd that I have never heard of it being done. It does not seem to be very popular here in NYC although I have seen it being advertised on subways which that in and of itself gives me reason to pause on doctors who advertise on the subway.

Again, I am on a running team of over 100 people and not once have I heard of any of my teammates seeing a podiatrist for anything other than feet issues. Not once has anyone mentioned seing a podiatrist for knee issues, ITB issues or shoulder issues.

I don't know how many times I can say this, but I am sure ESWT is for some people but it is like everything else, do your research before having it done. That is my whole point, do your research.

The whole thing is complicated and I would think long and hard about having treatment in a van by a technician giving anesthesia. Why not have my dentist do it for that matter?

Let the buyer beware.

Re: To Elyse

Ralph on 7/01/05 at 17:19 (177675)

Elyse,
I don't think it's that complicated. Basicly what you have is an FDA approved treatment for Plantar Fasciitis called ESWT. I think you'll find more Pods offering and promoting the treatment than Orthos yet it appears that the Orthos. were select or performed the initial studies on the treatment.

Since many of them still do not promote or use the treatment in their practices it make people like you and I wonder why especially when they are the ones saying it works.

Personally I think when ESWT was FDA approved, Podiatrist assumed that insurance companies would jump on the bandwagon and pick up the tab for this pretty expensive treatment. Maybe dollar signs were already in their eyes but their apple cart of increased income from this treatment was upset by one lone doctor named Birchbinder who's lone study became the bible for present insurance coverage which presently is little to nothing.

What it boils down to is a patient must find out all they can about the treatment and then decide if they want to spend the money out of pocket to try it. The Podiatric doctors here say it's great, but we don't see any Orthos here backing them up and the plain fact seems to be that few Orthos are even offering it in their own practices.

Bottom line it's the patients choice and it's best made with unbiased opinions if that is at all possible.

Re: To Elyse

Dr. Z on 7/01/05 at 18:19 (177679)

How about more podiatrist treating FEET then orthopedic surgeons. Buchbinder wasn't the real reason for the lack of insurance . The expensive FDA process and cost of the procedure was. Bottom line it has always been the patient's choice what other choice is there ?. The rest of your post about dollars and the apple cart etc etc etc is just plain ridicuous but you are entitled to your opinion based on your own personal experience.
I find many patients willing to pay for a procedure that is effective and can avoid foot surgery, not everyone is going to be right for ESWT and not every one is right for anything.

Re: To Elyse

Dr. Z on 7/01/05 at 18:33 (177681)

Ralph,
There are two FDA approved machines for CLE in the USA

Re: To Elyse

Dr. Z on 7/01/05 at 18:34 (177682)

Left out the obvious MORE FEET

Re: To Elyse

Elyse B on 7/02/05 at 04:58 (177717)

perfectly said Ralph.