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Posted figures maybe for advertising purpose ok by me.

Posted by Ralph on 3/08/05 at 10:03 (170684)

Personally I'm confused by the numerical percentages used on the websites of doctors who advertise that they provide ESWT and I'm not certain that they even matter accept for advertising purpose.

After looking back at some of the older ESWT posts there apparently was plenty of arguement about this in former days. I didn't understand half of what I read, terms like VAS numbers, Roles and Manley scores, double blind number of pulses etc. etc.

I decided instead to look at actual doctor's websites and many do not match each other unless they are using the same advertising line. Dr. Weils website as an example doesn't use the 94% number at all. Why his and some others are different I don't know. This is on his website. 'The Weil Foot and Ankle Institute has performed ESWT since February of 2000. Our clinical studies have shown a 70% success rate while using ESWT to treat plantar fasciitis and other tendon problems involving the foot and ankle. 70% of patients treated have had a reduction on a 0-10 pain scale by at least 5 for their condition.'

For this lay person I like the explaination about ESWT I could understand found on this insurance website http://www.regence.com/trgmedpol/medicine/med90.html

It's enough ESWT explaination for me and it used a lot of references.
How does that advertisement go 'I'm done with the dish', well I'm done looking at ESWT percentages.

Re: Posted figures maybe for advertising purpose ok by me.

Dr. Zuckerman on 3/08/05 at 11:47 (170689)

I like some will get better immediately, some will get better in a few weeks and some will get better in a few months or more. The key is it takes TIME.

Re: Posted figures maybe for advertising purpose ok by me.

elliott on 3/08/05 at 12:58 (170703)

Dr. Z,

While your new proposed language is not incorrect, it really offers no information at all, other than that one cannot predict when recovery will take place. The Q was, 'What kind of recovery can I expect?' The A could then be, 'Don't expect anything.' :-)

If the key is it takes time, a lot of it, then if it takes a year or two to get those success rates up high enough, many will have got better from the passage of time, not the ESWT. They also don't want to wait that long.

Further making things murky is the word 'better': does that mean totally better; partially better; good enough? Are you going to base the language on FDA data (which would be more credible)? Ideally, it would be nice to say something like, 'a% get at least b% better by 12 weeks, c% get at least d% better by 6 months, and e% get at least f% better by 1 year.' Whatever.

Re: Posted figures maybe for advertising purpose ok by me.

Dr. Zuckerman on 3/08/05 at 13:26 (170710)

If you use the FDA Dornier study 62% reported an Excellence or Good result at the 12 week mark. All had at least 50% reduction in VAS. These patients were satisfied with their ESWT treatment.

Re: Posted figures maybe for advertising purpose ok by me.

Fed Up Also on 3/08/05 at 14:00 (170714)

So basically, if you had a VAS of 10, a reduction to 5 or 50% (which is still moderate pain) is good? Really?

And the numbers don't add up, 62% report an Excellent or good result at the 12 week mark. Doesn't that mean 38% had a Fair or poor result after 12 weeks? So how does 90 or 94% come into play?

SSSOOOOOO, Dr. Z, how could ALL report a 50% reduction in VAS when 38% optained a Fair to poor VAS after ESWT. Is the 50% and average? Did most of the 38% get little to no cure? So how could ALL report a 50% reduction in VAS?

And THESE PATIENTS were satified with the ESWT treatment. Were they ALL satified with the treatment procedure or the treatment/cure rate?

I know what the FDA (PMA - Premarket Approval), the College of Foot and Ankle Surgery and the AMA say (which doesn't agree with your sites information/stats), how do you explain the radical differences?

Re: Posted figures maybe for advertising purpose ok by me.

elliott on 3/08/05 at 14:04 (170715)

Ralph:

I think your post title is suggesting you don't mind misleading advertising on ESWT Web sites. I strongly disagree. Just like with other remedies, a lot of people can get misled by exaggerated claims and fork their money and bodies over whereas they might not have otherwise. Is that a good thing? And what if it involves a Web site actively soliciting patients here?

You've been asking a lot of questions lately. No one has to delve deeply into the technical aspects of treatments if they don't want to, but if one is going to ask so many questions, wants answers and wants to get past the hype, especially with newer treatments, that is sometimes the way to do it. If you have the patience for it, most of it is not as tough to figure out as you imply. For example, VAS (Visual Analog Scale) is an 11-point scale with points 0, 1, 2,...,10, with 10 being maximum pain (the scores usually are subjectively selected by the patient). The exact definition of what the pain scale represents (e.g., first step in the morning, just pain, etc.) and the minimum starting number (e.g, 7) to be eligible for a study can vary based on the study. If, on this scale, a patient improved in 6 months from an 8 to a 4, then that was a 50% improvement in 6 months. The oft-quoted Roles & Maudsley scale is a 4-point scale, where the patient starts at a 3 or 4 and must reach a 1 or 2 to be called a success; each of these four numbers is defined precisely as to pain or function level and can be found in a web search. The actual study papers themselves are reasonably readable to laymen, certainly enough to verify claims.

I get blasted a lot on this site for being too confrontational, too mean, too negative, too whatever, but all I'm seeking is truth and honesty. I don't want to stand out, but disappointingly, there are very few others who do, so here I am. Some come here and say all they want is to know the true success rate of a particular machine, and in the same breath say that all they see is arguing and bickering over stats. Well, how are they going to find out the true success rates without them being stated accurately or abuse of stats they are relying on corrected? IMO, many others here prefer to just make friends and shoot the breeze, and don't give a hoot about accurate advertising, and would certainly prefer harmony even at the expense of truth. Fine; they're entitled. My own feeling is that just a little vigilance on the part of the board as a whole would prevent an advertiser from using misleading language or at least expose it, and then harmony would be achieved anyway and with minimal effort. I have seen this work on other sites, and wish it were here too.

Re: Posted figures maybe for advertising purpose ok by me.

Dr. Zuckerman on 3/08/05 at 14:07 (170716)

If you would like to read the original article written by Dr. Zingas. If is available in The Foot and Ankle International Journal published just recently. It should answer all of your questions and may be helpful to you

Re: New Airline Annoucement.....

Fed Up Also on 3/08/05 at 14:13 (170718)

Ladies and Gentlemen, welcome aboard flight 812, non-stop service to New Orleans, on today flight we expect a smooth ride and have a 90 to 94% chance of arriving on-time, we also expect 62% of you to arrive hurt from unexpected turbulance and 50% of those to have serious injuries and the other 38% will be injuried critically and/or killed. Sit back, relax and enjoy the ride, and to the 38% of you, we've increased your fair price drastically because we think it will make you feel better (sigh, we hope). Thank you for flying with us today.

Re: Dr. Zuckerman

Fed Up Also on 3/08/05 at 14:15 (170720)

Dr. Z.,

Do you answer all your patients this way? Wouldn't a straight forward, logical answer (which I've yet to see) put this issue to rest?

Re: Dr. Zuckerman

Fed Up Also on 3/08/05 at 14:25 (170724)

I paid enough to the Pediatrist, now I have to pay $20 to view an article about the cure of a lifetime? Come on, give US a straight answer.....

Re: Dr. Zuckerman was the following Australian Study Incorrect???

Fed Up Also on 3/08/05 at 14:37 (170726)

Synopsis
Summary of Buchbinder R, Ptasznik R, Gordon J, Buchanan J, Prabaharan V and Forbes A (2002): Ultrasound-guided extracorporeal shock wave therapy
for plantar fasciitis. A randomised controlled trial.
JAMA 288: 1364-1372. [Prepared by Chris Maher, Editorial Board member.]
Question: Does ultrasound-guided extracorporeal shock wave therapy (ESWT) improve, pain function or quality of life in patients with plantar fasciitis? Design: Randomised placebo-controlled trial. Setting: Melbourne (Australia) radiology clinic. Patients: Of 178 patients referred to the clinic, 169 were eligible for inclusion and 166 consented and were randomised. Criteria for inclusion included: older than 18 years, presence of plantar heel pain for at least six weeks and ultrasound confirmed lesion. Exclusion criteria included: inflammatory arthritis, previous surgery to heel and previous ESWT to any site. Interventions: Eighty-one patients were allocated to the active ESWT group and 85 to placebo ESWT. Both groups received 3-weekly treatments.
In the ESWT group, patients received either 2000 or 2500 shock waves per treatment of energy levels varying between 0.02 mJ/mm2 and 0.33 mJ/mm2, pulse frequency gradually increased to 240 per minute, a minimum total
dose of 1000 mJ/mm2 being the treatment goal. In the placebo group, treatment consisted of 100 shock waves per treatment, energy level of 0.02 mJ/mm2, frequency 60 per minute, total dose 6.0 mJ/mm2. Outcomes: Overall, morning and activity pain were measured with 100 mm visual analogue scales, reported walking tolerance was measured on a 6-point ordinal scale, disability was measured with the Maryland Foot Score (range 0-100) and a patient-specific measure (the Problem Elicitation
Technique), quality of life was measured with the SF-36 (eight sub-scales each scored 0-100). Outcomes were assessed at six and 12 weeks by a blinded assessor and analysed according to the intention-to-treat principle.
Result: There were no clinically significant differences between groups at baseline. In general, there were no statistically significant between-group differences for any outcome (two sub-scales of the SF-36 were marginally significant at six weeks, p = 0.03 and 0.05, and favoured placebo). For example, at 12 weeks the between-group difference (95% CI) for change in overall pain was 0.6 (- 10.3; 11.5), morning pain 0.2 (-12.7; 13.1), Maryland Foot Score 1.2 (-7.6; 5.3), SF-36 Physical Function score -2.3 (- 9.9; 5.3). Conclusion: In patients with plantar fasciitis,
ESWT is not effective in improving pain, function or quality
of life.
Commentary
A Cochrane review and three systematic reviews have provided conflicting conclusions on the efficacy of ESWT. Heller and Niethard's (1998) meta-analysis of 24 RCTs (1585 patients) concluded that ESWT was of clinical
benefit. Bodekker et al (2001) reviewed 21 RCTs specific to plantar fasciopathy and determined that none of the trials satisfied all their criteria and that further RCTs were needed. Crawford et al (2002) concluded that limited evidence existed supporting the effectiveness of low energy ESWT. Ogden et al (2002), in a meta-analysis of eight RCTs (840 patients), concluded that ESWT directed at the enthesis of the plantarfascia on the inferior calcaneus is a 'safe and effective non-surgical method of treating chronic, recalcitrant heel pain syndrome that has been refractory to other commonly used non-operative procedures.'
There are a number of possible reasons for the Buchbinder et al result. Firstly this study included subjects with a relatively short symptom duration (from eight weeks with median duration 36 weeks) whereas previous studies have not included subjects of less than 24 weeks duration, which may be prior to the processes of the inflammatory response
having stabilised and prior to maturation of scarring within the fascia. Secondly, the authors describe the ESWT focus targeting criteria as being within the thickest area of the plantar fascia. This may differ from results obtained in studies that have targeted, under imaging guidance, the symptomatic region at the enthesis and obtained a treatment effect.
This study does not support the use of ESWT in subjects who have a symptom pattern of less than 24 weeks. Gordon Waddington The University of Sydney References Boddeker R et al (2001): Clinical Rheumatology 20: 324-330.
Crawford F et al (2002): The Cochrane Library. Oxford: Update
Software.
Helbig K et al (2001): Clinical Orthopedics 387: 68-71.
Heller K and Niethard F (1998): Zeitschrift Für Orthopadie Und Ihre
Grenzgebiete 136: 390-401.
Ogden J et al (2002): Foot and Ankle International 23: 301-308
Critically Appraised Papers
Extracorporeal

Re: Dr. Zuckerman was the following Australian Study Incorrect???

Fed Up Also on 3/08/05 at 14:38 (170727)

Result: There were no clinically significant differences between groups at baseline. In general, there were no statistically significant between-group differences for any outcome (two sub-scales of the SF-36 were marginally significant at six weeks, p = 0.03 and 0.05, and favoured placebo). For example, at 12 weeks the between-group difference (95% CI) for change in overall pain was 0.6 (- 10.3; 11.5), morning pain 0.2 (-12.7; 13.1), Maryland Foot Score 1.2 (-7.6; 5.3), SF-36 Physical Function score -2.3 (- 9.9; 5.3). Conclusion: In patients with plantar fasciitis, ESWT is not effective in improving pain, function or quality
of life.


Re: Posted figures maybe for advertising purpose ok by me.

elliott on 3/08/05 at 14:56 (170730)

Dr. Z, you said:

'If you use the FDA Dornier study 62% reported an Excellence or Good result at the 12 week mark. All had at least 50% reduction in VAS. These patients were satisfied with their ESWT treatment.'

Are you proposing that as your new language? It does specify that it's including Good with Excellence, er, Excellent, a positive step. It might be nice to say that this was based on the R & M measure of success. But it still has problems. You probably should say that this 62% was from the blinded treatment group. Are you also going to reveal that the blinded control group's R & M success rate was a still respectable 40%? Or that this was a secondary measure of success in the FDA study and that other important measures of success came out not that significant at 12 weeks? Furthermore, you then say 'All had at least 50% reduction in pain.' Unlcear. By 'All' do you mean everyone in the treatment group? This would be false. There was a MEAN improvement of 56.5%, but the RANGE was given as 4.1 +/- 3.1, so some had a final pain score as high as 7.2 at 3 months, not much improved from the starting average of 7.7, and certainly not a 50% reduction in pain. If you mean that all those who were labeled a success (E or G) under R & M also had a 50% improvement in pain, I don't see that anywhere in the FDA report. The wording should be clear and accurate.

Re: Dr. Zuckerman was the following Australian Study Incorrect???

Dr. Zuckerman on 3/08/05 at 15:14 (170731)

Yes

Re: Posted figures maybe for advertising purpose ok by me.

Dr. Zuckerman on 3/08/05 at 16:51 (170739)

Elliott,

If you were in pain every day for the last eight months and had tried local steriod injections, stretching vioxx, boot cast, physical therapy all which still leave you in pain, and unable to take a any steps without limping for at times twenty minutes would you try ESWT as a treatment choice

Re: Dr. Zuckerman was the following Australian Study Incorrect???

Rob M on 3/08/05 at 18:07 (170744)

Dear Fed Up Also

I certainly don't speak for Dr. Z. There were a few important notes presented in the commentary to this study (by Buchbinder et al)

First, the results don't speak directly of improvement but of statistical differences in outcome between treated and placebo groups. Both groups of patients got better. (on some measures)

Second, patients with PF as young as 6 weeks were included. We know that in the majority of cases, PF will clear itself, and many never seek help for the problem. So if many of members of either group would have gotten better anyway, then it will serve to minimize the effect of treatment.

Third, targeting the thickest part of the plantar fascia (versus the insertion point) is not typical, at least at our clinc. The results are not surprising to me since sound waves have little effect on tissue with a high water content, and have greater effect the more dense the tissue is. As an experiment, administer a few shocks, at low level to a muscle, or fleshy part of the body. You will probably feel nothing. Now do the same to a dense part, like a bone. You will jump. Accurate targeting of the correct location is critical in treatment with ESWT because the beam is very narrow. Being off by only a few mm can make a difference. (I have had ESWT in several locations, several quite uncommon)

Fourth, I take issue with the definition of placebo. They delivered a very small dose of ESWT, NOT nothing. Making a placebo is a very very difficult thing to do with ESWT because it must be indistinguishable to both the patient and researcher from real treatment. The therapist had to have realized that this was a placebo patient because they only gave them 100 shocks at low level. The patient might also have realized it if they know anything about ESWT and knew that they should have received more. At low dose, the patient would have felt little or nothing and may have suspected they were part of the placebo group.
Other studies have tried to mask the effect of the shockwave by putting a thin metal foil inside (or outside) the shock head rubber membrane. This is probably a better method. However the technician delivering treatment would still know the difference from patient feedback or from ultrasound monitor. (The creation of cavitation bubble artifacts for instance)

Fifth, patients were allowed to continue taking Acetominophen. Compare this to the Rompe et al study (seminal European low energy study) where no other treatments after ESWT were allowed. The Rompe study also required 6 months of pain AT THE INSERTION of the plantar tendon and that patients had failed conservative treatments for at least 6 months. Heelspur present on X-ray, no connective tissue disease, or arthritis. (Why did the Buchbinder group choose a less specific set of entry criteria, and more lax post treatment controls?)

It is very unfortunate that the Buchbinder study was then used by BC/BS in their followup technical assessment of ESWT (2003) in combination with the Dornier and Healthtronics studies because it contradicts many of the earlier low energy trials (which showed benefit vs. placebo). Technical Assessments may be used by some BC/BS members to determine coverage.

The BC/BS assessment saw that in double blinded studies, 34%-47% of the placebo cohort showed improvement, whereas in the earlier, European single blinded trials, only 0%-4% of the placebo group saw improvement. They concluded that the single blind studies must be wrong, not because of the study data, but (the authors assert) because in studies of pain, double blinding is better than single blinding based on Turner et al 1994 . Yet if you accept the criticisms leveled in response to the Buchbinder study, another interpretation is that poor selection criteria or treatment location may be a more reasonable answer. (eg. allowing too many young injuries that would have improved anyway, not treating the insertion point) I found the BC/BS TE arbitrary in the acceptance of double vs. single blinding as the only possible explanation for the significant differences between placebo outcome between Rompe et al (and other European studies) and Buchbinder et al.

Reading the abstract of a study can be misleading. Often it is more important to read the whole study, compared to prior literature, and to understand what differences in approach might be significant.

I think that my points above also shed some light on why 'XX% of patients get better' is posted on some website while YY% is claimed by another. No two groups of patients in a study are identical, (they are all individuals) and inclusion criteria are often different in important ways, as are treatment protocols, therapist skill and experience.

So in brief answer to your question, the Buchbinder study is not incorrect. The results are correct for the group of 166 treated. Trying to extrapolate from these results to the population in general (or to the individual heelspur sufferer) is less clear.
.
Robert Mitchell
PainFree ESWT
1 866 444 3798

Re: Dr. Zuckerman was the following Australian Study Incorrect???

Dr Ben Pearl on 3/08/05 at 19:14 (170750)

I just had an eswt update article published in Jan.- Feb. American Running News which also speaks to the longevity of the cured cases. I will forward it to this site.

Re: Posted figures maybe for advertising purpose ok by me.

Ralph on 3/08/05 at 21:15 (170754)

Elliott,
I don't think any patient should be mislead about any form of medical treatment. I just don't understand where the % figures come from nor the background that others seem to know about ESWT.

You and the doctors seem up on all of this stuff so I assume that all of you have followed ESWT from it's birth.

I tried reading some of the older posts, but have no idea what a VAS is or how it relates to ESWT nor what a Roles and Manley scale is.

I did find on different percentages used on different doctors websites which lead me to think that they just used what ever number they wanted. I look at their websites as an advertisement. They are selling themselves and their treatments.

I found some doctors that apparently don't use ESWT yet and they never mentioned that it was even available.

My take is that the doctors that come here use and encourage patients to have ESWT. Taken in that light of course they are going to put their best foot forward. Should what they advertise matter, of course, especially if it isn't the truth.

Maybe what this board needs is a few more doctors that do not use ESWT nor believe in it to counter balance the weight in favor of this treatment.

Re: Posted figures maybe for advertising purpose ok by me.

Dr. Z on 3/08/05 at 22:38 (170757)

Ralph,
Here is my background. I came here years ago due to ESWT and Scott Roberts talking about ESWT and this site. This was an ESWT site. I helped to introduce the Ask the Doctor section and begin to learn about ESWT and how it was used for years in Europe and Canada. This was about five years ago. I answered for years by myself questions that people posted and I believe was the first doctor to even come to this site that I found via a search engine.
Elliott does know alot about stats, figures etc cause he works as a stat person. He talks about stats as if he treats patients every day. I talk about stats as if I treat patient patients every day. I really due treat patient every day.
All of the information about ESWT is from my personal experience and literature, FDA studies that I have read.
Elliott will pick apart stats and studies etc without ever even seeing any results in people or ever seeing a person or seeing an ESWT procedure.
I have asked Elliott to write to the FDA or Dornier with all of his comment ( not facts) and he has refused and or ignored. If you have comments ask them to the source
If is misleading to continue to ask a doctor who never claimed to be an expert in stat and refused to write to experts or the people who wrote the actual studies.
Here is just one example Roles Maudsley means Excellent , Good , Fair and Poor. The FDA Dornier study states that approximately 62% of ESWT treated patients reported either an Excellent or Good result at the 12 week period post ESWT. Well who cares the break down of which were Excellent or which were Good. They all stated that they were happy and could function in life and their pain was either gone or so reduced that it wasn't a part of their life. Well Elliott will now tell you that there more Excellent and less Good and that the good compared to the control were equal so this is misleading. Well its not just ask the patients that had the treatment or talk to the thousand of patients that I have spoken with that are satified with ESWT treatment.
If you are concerned about FDA studies or stats and ask the stat people.
What the Elliotts in this world due is to scare posters who then go on to either stay in pain or just have surgery and are then crippled for life.

Do they do this intentional I don't think so. Does this happen you bet.
Stats are important but they aren't the bottom line. Patient satisfaction is the bottom line. Being able to function is the bottom line.

We are talking about people not numbers. This isn't about misleading this is about helping people.
I think you get my point but you do have a choice read the stats yourself, listen to Elliott about stats without seeing or ever treating one single person, or talk what you understand or believe to be true and use it as best as you can. I wish you luck and will always try to answer any and all questions to the best of my ability

Re: Posted figures maybe for advertising purpose ok by me.

Dr Ben Pearl on 3/09/05 at 02:34 (170768)

As new data becomes available I will be adding it to my own website regarding eswt including links to this site. It is not the case that I am pushing eswt on my site or this forum versus the standards of care that have been set up pre surgery. To date I have only had 1 case where I suggested a repeat treatment & have suggested surgery to some treatment failures. Personally I am only doing about1 cases a month and have not garnered cases from this site.

Re: Posted figures maybe for advertising purpose ok by me.

elliott on 3/09/05 at 13:45 (170801)

Ralph:

Not sure what your difficulty is with VAS. Let's say you hobble into the doc's office and say your PF is killing you. He says to you, 'On a scale of 0 to 10, with 0 being no pain and 10 being the worst pain imaginable, what number would you pick to best describe your pain?' That is an example of a VAS scale. You select an 8. Other patients select their own number. Things like the average (e.g., 7.7) and the range (e.g., 4.7 to 10.0) for the group can be computed easily. Say 3 months after treatment (be it surgery, splint, ESWT, whatever), the doc asks you again what your new pain number is. Let's say it's a 4. Then your pain came down by 50%, that is, (8-4)/8 = 4/8 = .5 = 50%. The new average, range, and other data for the group can be computed easily. If the group as a whole averaged a 4, they had a 50% improvement in 3 months as a group.

The VAS scale can be defined as needed to suit the test desired. For example, instead of general pain, the thing to be measured can be more specifically first pain in the morning. So while you might be an 8 in the above example, you might be a 10 (hope not) for first-step-in-the-morning pain. The same statistics such as average for the group before and after treatment can be computed easily.

The definition of the 0 and 10 can be different too depending. For example, some docs define 10 as you are ready to have your foot amputated. Keeps the numbers down that way. :-) The definitions of what the VAS scale represents, when unclear, are always given.

VAS. Not such a big deal. Hope that helps.

elliott

Re: Posted figures maybe for advertising purpose ok by me.

Ralph on 3/09/05 at 15:21 (170810)

Are you saying that a VAS scale can be applied to anything? What do the initials actually stand for and who makes up what questions will be asked?
In other words who decides to ask me if I was in a test group about my morning pain instead of how I was treated during a procedure.

I recently had wisdom teeth pulled. Tell me if I'm correct. My Oral surgeon could make up his own VAS scale or score simply by asking the patients he treated that week specific questions.

He could ask us about our pain levels or he could also ask us about his office staff and the care we got. My question to you is if he gives out a VAS score is he obligated to tell us what questions were asked to make up that score?

Re: Posted figures maybe for advertising purpose ok by me.

elliott on 3/09/05 at 16:17 (170813)

Ralph,

A VAS (Visual Analog Scale) can be applied to anything. My doc asked for such a number (with 0 as no pain and 10 defined as requesting amputation) before I underwent TTS surgery. Not a big deal and not necessarily for a study; it can be useful for the patient's file. The questions asked are up to the doc or researcher. Usually, if you're in a test group, you are told so. Not sure of all the disclosure rules. Not much more to say.

Re: Posted figures maybe for advertising purpose ok by me.

Dr. Zuckerman on 3/10/05 at 14:11 (170884)

He does want to explain the rating so that you will undestand which is the bad end of the scale or which is the low end. This is why I like a Roles/Raudsley score meaning Excellent, Good, Fair, Poor. I use the classic definition that were defined by Roles/ Maudsley.
You can find this on this site or if you would like I can list them.