Needling evidence collection.

"My pork is excellent".
REG, is that "prison talk"?

 

My hiatus is perfectly intact - no idea what you are actually referring to but if its a low blow to my self esteem because I have a public persona on these forums, I would hardly think its worth it.

PS I don't write my own bio, we overpay someone else for that!

Needling? We have pigs, testicles, cooking, research, and now thanks to Hamish prison references. This thread is about anything other than needling.

 

Paul my apologies.

My introduction of pigs was my attempt to lighten up my public persona.

Unfortunately at he moment Pigs are the animal of the year in the UK. Not too sure why a push for good animal husbandry, or a back to the War mentality of a recession racked Britain. (TV may have influenced this, my nephew is a TV producer in the midlands and he has pigs, and sheep but they are a mistake, hens do well, I digress.)

The only film ever made that featured a Chiropodist was Alan Bennet's A private Function, with Michael Palin as the bike riding chiropodist. This involved a pig and in some ways the image of the 'shiropodist' portrayed still exists in the UK.

How was I to know that that pigs would strike a cord in Simon's 'heart',

Sorry about the midland references, it's unlikely anyone not from there will understand them.

Hopefully the thread will come back into line, if not perhaps we could ask Admin to transfere all the pig stuf to the break room.

I agree with you Hamish was well out of order with his prison reference, his only excuse is he is a Geordie.

Low blow, not at all. There seems to be a general problem when the content of web sites is refereed to, and just because you did not write it does not absolve you from publishing the content.

I do applaud your ambition. Fortunately or unfortunately I came to this profession as a very mature (old) student, have now done 15 years in PP and now looking forward to retirement. Not because I do not enjoy the work, but having mainly involved myself in the politics of British Podiatry I now despair for the future.

It is researchers like Simon and I assume yourself that are the hope for the future. I just wished there was a better network so more Pods could get involved, and make a contribution.

Time to stop sparing?

:drinks Bob

 

So sorry for the offence I must have caused. It is apparently well known (REG thank you for raising my "Regional difficulties") that I am not capable of cogent nor any rational thought and ealsily diverted, oooh look a sparkly pretty thing.........

 

WHERE?? WHERE???

I slaughtered locusts once. Does that count (taste like salty bugs if you put salt on them if anyone is interested).

Ok. Lets drag it back to needling. Bob has raised some excellant points to chew over. Got a minging day in clinic ahead but I WILL get to them as soon as I can give them the attention they deserve.

 

...and whats the issue with the content? Seriously you put your name on a forum thread and someone tries to find fault with you, your character, your pigs or your way of life. Why? Remember this is a "forum" not real life. We are real people, not words on a page - we (myself included) can sometimes forget that.

The fact that myself and a few others such as Kevin and Craig choose to publicly show our names/profiles is our right. Personally I believe if you want to have a personal opinion on a forum then let people have the decency to know who you are. I have learned to respect your right to privacy if you don't wish to be known, however that doesn't give others the right to crucify my profile simply because they can hide behind a veil of hidden identities.

Rant officially over.......

No applause necessary......If you knew me you would know that I am not that ambitious. In fact I am more interested in my kids now that 1st MTPJ function, and if you knew exactly how obsessed I have been with 1st MTPJ function....then that says something!

Please don't compare me to Simon, compared to him I couldn't research myself out of a wet paper bag, on a rainy night with a box cutter. I simply like hanging round on these forums because people like Simon, Kevin, Craig and many others teach me and inspire me to do new things everyday.

Never! Its what makes us passionate people who we are.

 

Regarding your study design for needling, specifically the control group, I should think it would be possible to perform a "sham" needling in a similar way to which sham debridement is performed. So for subjects in this group you would give them a local, debride with scalpel and then press a blunt needle repeatedly against the skin but without penetration, then dress the area as you would for the study group.

 

Does your wife know about this fantasy? I remember stopping at a farmyard near Butterleigh in Devon for some Ci (or scrumpy to the uneducated) and witnessed a very strange sight involving a farmer's wife, a Dartmoor pony, two collie dogs and a goat. Is it something to do with the water supply or fermented apples that elicits a desire for beastiality? I hear Welsh hill farmers also have a similar fetish for sheep but I suppose quite a few are just plain baaarking mad....

 

@Mr. Spooner, so it can onl be a single blind study at best?

 

Actually it's Dr Spooner, but you don't need to be so formal with me Hamish, please call me Simon everyone else does.

In answer to your question, you could add an extra layer of blindness as follows- lesions from both groups are photographed at pre-treatment/ pre-sham; treatment and sham treatments are then carried out by an independent practitioner who has no other role than to carry out the treatment or sham treatment; at follow up photographs of lesions are again taken. An expert panel is then provided with the pre and post photographs for comparisons against a given criteria. Expert panel is blinded as to which group the photographs for each subject came from. This way the "assessors" are blinded to which group each subject was within. Pretty simple really. It's impossible to blind the actual practitioner who performs the treatment due to the nature of the treatment; you'd need to use a machine. You could give them a script to follow, which may reduce some of the bias that may come from the way they interact with the patients. Hope this is helpful.

 

Simon

Please indulge me.

I can understand your sham treatment but these are my thouhght

I'm assuming by using a sham treatment the proposal is to attempt a blinded random control trial?

My question is, is this really necessary to investigate 'needling'?

Certainly such a trial would remove it from the scope of a PP. Also would an ethics committee allow an unnecessary LA, they no longer allow students to practice on each other?


What would the hypothesis and null hypothesis be and what could you say at the end of the data collection? That verruca (no inclusion criteria) resolve more frequently when treated with LA and needling than with LA alone?

Oh and the sham treatment, well if anyone who has read anything about the appearance of a needled VP and one that has had a blunt instrument against the skin, I suggest they would not be fooled.

Are there any other methods that could produce meaning ful results.

Mark,

Sorry cannot comment on what goes on in Devon Simon is your man for that.

Cornwall is a separate country with very different traditions.

Did the big cyder hunt two years ago, all producers in Cornwall and South Devon, well worth the trip, need a tea total driver though.

 

Depends on the level of evidence you wish to produce. You can report on a single case study if you like, but this is much lower in the ranking than a controlled trial.

I disagree. Why do you think it removes it from the scope of a private practitioner?

That's for the ethics committee to decide.

Something like that. I don't remember discussing inclusion criteria, you can match by site, size, gender of patient, age or whatever floats your boat. Ultimately it's up to the researcher to decide if any factors such as this may influence the outcomes. As I get about as excited when I see a VP as I do watching cricket, I'm probably not the right person to ask in terms of this.

You do want you can Bob. Lets assume we photograph the lesions as I described in my previous post, I'm not talking about taking photographs immediately post operatively but several weeks later, when ~I'm assuming we should be able to tell if the VP is still there or not, I'm not sure how long this should be (see above) but I'd presume by this time it will not be too obvious as to which received needling and sham. In terms of "fooling" patients- these don't generally know what to expect and hey if it's good enough for Dean Richards- you could use a blood capsule!

See my first comment above.

 

P.S.

Not necessarily. You could have blinded random controlled trial without a sham using the photographic approach I have described. By performing the sham we are trying to better "winkle out" placebo and Hawthorn effects.

 

my appoligies had no idea you had a phd.
for a practical person looking to se if something like this worked i the way a practitioner would work, the extra layers seem extreme and it could be more simple. I am not saying it would tick all the boxes for those that need all the boxes ticked, but there would be a simple effective battery of evaluations achieved with far less fuss

 

Hamish that could mean the difference between whether it was considered gold standard top class evidence or run of the mill clinical opinion.

Its sometimes the "extra layers" as you call them that make good research what it is.

 

Hi folks, got distracted yesterday, pig escaped and my daughter went into labour.

Paul and Simon, agree that gold standard research is the target to aim for but and it's a big but in the main clinicians are happy to settle for less.

I would suggest in the case of needling to be able to say for instance to our clients and insurers 'from a sample of 200 procedures 8 out of 10 resistant VPs in people over 25 resolved.'

This as you say would only be the equivalent of a clinical trial but surly better than the present anecdotal reporting. The technique is what 40 - 50 years old? If the trial was conducted and rich data collected it could be the basis for further investigation. My fascination has always been the 'failures' not the successes. At this stage 'we' are still speculating on the mechanism by which it works.

Given the appallingly low amount of research in Podiatry and the prevalence of 'questionnaires' done for undergrad research modules I think we have to 'lower our standards' to encourage more Pods to participate.

Simon you say you think a 'placebo' based trial is practicable for a person in PP. I'm having enough of a struggle in this recession to convince patients to pay my 'professional fee' rather than a cheapy in the comfort of their own home with a free foot massage, just cannot see them paying £90 for a possible 'sham' treatment.

Paul while Googling you (sorry but information is important) I came across a journal you were mentioned in in which a debate between academics and clinicians took place the clinicians won, did not read it but would it be relevant to this debate?

Bob Golding

Newquay (Englands surf capital)

Cornwall

 

I wouldn't be charging people entering a trial to help me with my research, Bob. :morning: If you want to get involved in research, and you intimate that you do, it might actually cost you money, Bob. But personally I do it for the love of it, certainly not for the money. And anyway, who said you'd be the one performing the treatments, you could be on the expert panel judging the photographs. I suspect though, if you wanted to charge for your time to look at the photo's, you might be disappointed when the lead researcher finds someone else who'll do it for free instead.

 

Simon,

Ok.

I tried the free stuff on a little bit of research I was interested in. Bromihydrosis.

Did the literature search, very flimsy, the evidence not my search, and bought a Klenz machine. Nano silver and ozone claims to kill everything. Certainly takes the smell out of trainers.

My theory/ guess was that you could better treat Bromihydrosis if you not only treated the feet but also the foot wear which could act as a reservoir of bacteria.

Offered 3 people with really pongy feet free treatment and use of the machine.

Take up a great big Zero.

About a year ago since which I have not smelt a bad foot.

Guess I'm a rotten sales person and people do not trust a free lunch.

I do find it frustrating, yes I would like to contribute to the 'body of knowledge' but I want it easy, I'm not driven on this like you.

Still think we should be looking at all research methods rather than the RBCs.

Role on Saturday when Bob the pig goes.

The other Bob

 

Yeah, I can see that.

 

Simon,

Just trying to be honest.

I do not think I am alone in wanting it easy and I think if academics tried to make it 'easier' then a lot of people would give it a try. Who knows then perhaps some might become hooked?

Some good examples of mass participation are the annual bird watch, all amateurs giving a bit of their time the academics then use their skills to analyse the data. I think another one was allowing home computers to process data when not being used.

Both ingenious ways of using people for science.

Is this not a challenge worth accepting. Even in the sports field 'inclusion' is a way of finding the Gold medalists?

By the way what are your views on cricket?

Bob

 

I think its not as difficult as you want to perceive it as being. I've given a reasonable methodology, I've told you that you could publish anything from a single case study to a blinded placebo controlled trial, yet still there's always a reason you can't do it.

I put it to you, that deep down, you don't really want to. Take your bromhydosis study- from where did you attempt to recruit subjects for the study? How did you publicise the study? You could have gone on local TV or Radio, rather than waiting for the subjects to turn up as paying customers at your clinic, which is what you intimated you did in your previous post, you could have offered to pay the subjects a nominal fee. It's amazing what people will do for a couple of quid.

It depends on the question you are trying to answer and, at the risk of repeating myself and Paul, the level of evidence you wish to produce. We could ask all UK podiatrists to tell us how many V.P.'s they see next week- what will this tell us?

We could ask all UK podiatrists to do one needling procedure on one patient and submit the result- what would this tell us?

Too slow, not physical enough, a summer game that is now played all year round.

 

Hello Bob

It's just human nature to want it easy, but sometimes you've got to do the slog if you want to achieve something worthwhile. Reading this and the other thread on Laser Rx of Fungal Nails reminds me of the debate on Researcher -v- Clinician and that we haven't seemed to quite grasp the importance of correlation and cooperation between the two. It's certainly useful if not invaluable to have people who can wear both hats in the profession - like Simon - as they can guide and advise clinicians like you and I through the process required for research and publication. It is vitally important for the profession that published research is conducted in an acceptable and recognised manner; what we do should be able to stand up to scrutiny from all quarters -not just within the podiatric profession.

I guess when clinicians discover a mode of treatment that works for them and their patients they (we) get excited and full of enthusiasm - nothing wrong with that - but we do ourselves and our patients and professon an injustice if we cannot substantiate our claims in a properly verifiable manner. Podiatry has struggled over the decades to gain respect and recognition from the wider medical community - not to mention the general public - however there have been tremendous advances in research methodology and outcome measures in some areas - podiatric surgery for example, and we should strive to achieve similar in all areas of our clinical practice. There's always the danger we simply revert to type and retreat into our respective camps - but a good profession has their researcher and clinician working together to achieve the same goals.

Rather than personalise the debate - something that happens all to often in new developments (think Rothbart, Glaser, etc etc etc) arguments should be objective and honest - difficult questions should be answered directly and truthfully and vested interests declared at the outset. Where there are weaknesses in those arguments that is usually where the debate collapses. I can't see the value in questioning the methodology if we aspire to rigorous examination and worthwhile research and outcomes. We do everyone a disservice if we do otherwise.

Best wishes

 

Been following with interest.

Certainly one can come up with a "gold standard" RCT for needling OR Laser. However as Bob has observed while these are great in theory they are not always entirely practical.

The VP double blinding, For eg, would involve finding 200 patients willing to go through a tibial block against the possibility of getting an effective treatment. Unless it involves the NHS or a university it would also involve them paying for the priveledge... or an IPP swallowing the cost of 200 odd hours worth of clinical work, and the costs involved, for the betterment of mankind.

I don't know that I could find 2 who'd do that, much less 200. And I certainly could not afford to lose what would amount to about £20,000 just to produce such a study.

There is a consideration to be made in terms of what is practical. Where the practical and plausible meets the rigerous and significant is where we should be looking.

The Double blind RCT for needling is as unlikely as a single case study is useless.

Finding the middle ground, thats the key.

Regards
Robert

 

Not sure, where you get 200 from Robert? Did you do a prospective power calculation for that? I'm not going to argue over this much more because, frankly, I don't really care whether this study ever gets done or not. But, I do suspect you would be among those pointing out the limitations of a study that found no statistically significant difference between sham and treatment, but was methodologically weak, Robert. Better to perform one good study than a hundred poor ones wouldn't you say?

 

Bob's suggestion

I surely would!

And I agree. But that said I'd rather see 1 half decent study than no study at all. And to do a really solid study on this would, from a practical point of view, require an institution (like a university) to take it on. Thats the ONLY way I can see to get adequate numbers and overcome the issue of cost.

Unlike things like laser, or a particular brand of insoles, no commercial organisation stands to gain from proving it works.

Accepting that a perfect study is beyond my power to carry out, try this one. Bob started with some good ideas and points.

The way to carry out a trial is to find your hypothesis and try to disprove it. In other words, to prove your null.

Let the hypothesis be "Needling is effective in resolving 75%< of persistant VPs"

Now lets assume that if I needled 100 vps 90 would resolve. We can't just accept that because there might have been something besides the needling it causing it to happen. For me the main elements I'd want ruled out are:

regression to the mean
Placebo
Hawthorn

The only way to rule these out is the double blind study. But we can go some of the way without that.

If we limit the inclusion criteria to long term lesions and have a solid number of participants we reduce the chance of fluke regression.

If we Include only lesions which have had previous treatment we REDUCE the Impact of the placebo effect. Since we know that the placebo effect is proportionate to the level of intervention (saline injections are better than sugar pills) the more traumatic the previous intervention the better. If the placebo of cryo did'nt do it the placebo of needling is less likely to (I suspect)

Hawthorn effect... we can't get rid of that without a control group. But all we need do is mention in passing that we may record the results of the treatment for research purposes. Its not like being in a trial where you have to come back every week and fill in long questionaires.

So how about a study which only accepted lesions of more than 5 years duration and which have been previously been frozen. I reckon we should be able to muster enough of those to produce meaningful numbers of patients for the statistical power.

The more stringent we are with the inclusion criteria the smaller the numbers we will end up with which will result in weaker statistical power OR the longer it will take. I might find enough patients willing to do the double blind trial but it would take me 20 years to do it.

Not perfect. But better than nothing...

Regards
Robert

 

Robert and all, let me ask this question, if double blind placebo controlled trials are so hard to perform, and we can "get adequate evidence" using "easier" methodology, why are double blind placebo controlled trials viewed as the gold standard?

Research isn't "easy" and cutting corners leads to the wrong conclusions being drawn. As for one reasonable study being better than no study at all- is it? What if "we know" that one study is fundamentally limited (some would use the word flawed)- the media don't necessarily know that, nor do patients/ public- one poor study can do more harm than good, IMHO.

P.S. I thought you worked for a big institution, Robert.

P.P.S. lets say that we worked out that we needed 20 subjects for our study to be of adequate power, would this be financially viable? Lets say we did a pilot study using 10 subjects in each group, would this be financially viable?

Which raises a very, very important question: which is the better study: a double blind placebo controlled trial that is under-powered or an uncontrolled trial with adequate power?

 

One further thought: I've never used the needling technique so tell me if I'm missing the point, from what i understand you put a local anaesthetic in, then repeatedly stick a syringe needle into the lesion. Could you use a tattoo gun without any ink in it?

 

Haven't seen or experienced a tattoo gun working but providing it penetrates through to the dermis and the equipment was sterile - don't see why not. Get a big enough one and you could market your Rx as Bazooka that Verruca!

 

Tattoo needles are sterile; got to penetrate to the dermis or ink wouldn't be permanent. Just a thought, as I said, but this would enable the automation of the process and maybe improve control of depth of penetration. Certainly speed it up, and as time is evidently money... Wonder if you could get away without a local infiltration using a tattoo gun? Tattooist generally don't do local infiltration, but I guess they don't usually tattoo the plantar surface of the foot and into VP's- just thinking out loud.

 

Hi Simon

Interesting thoughts. There is though something important in the "feel" of the lesion for the Podiatrist in the needling process. I know some have considered that what appeared to be a VP on the surface "felt" very much different to VP's previously needled. This may be something that Robert and Bel can best describe, if they don't mind.

Ian

 

http://www.tattoogun.org/

Nice designs at the above link. Think you will need anaesthesia as the smallest dia needles are 16g (ouch) and this will aways be unacceptable to some, especially those with needle phobia. Plantar infiltration with say a 30g needle can be reasonably straightforward and with minimal discomfort providing the local is delivered slowly. I know what I would prefer - a second or two of discomfort or 48 hours with monochloroacaetic burns - especially if the outcome was more favourable with the former!

 

Simon,

with respect and ignoring the personal jibes about my slackness, I would like to push that I think I live in the real world. I have spent a long lunch time 'CPD ing with a colleague, discussing amongst other things CPD and research, and eating bacon. He thinks you are a Tosser, cannot understand why I would refer a patient to you, his only evidence is anecdotal. That's the real world.

Now if we (clinicians) read the results of one of your wonderful RBCs what will they read? The abstract. Depending on that will depend on whether they adopt the 'evidence' into practice. They will not look at the 'power' of the research or understand the stats. They may even look at the sample size say 20 and dismiss it. It may be statistically significant but does not impress the 'real world'.

P.P.S. lets say that we worked out that we needed 20 subjects for our study to be of adequate power, would this be financially viable? Lets say we did a pilot study using 10 subjects in each group, would this be financially viable?

Possibly yes but see above.

Which raises a very, very important question: which is the better study: a double blind placebo controlled trial that is under-powered or an uncontrolled trial with adequate power?

You tell us you are the researcher, I know which one as an 'amateur' I will take more notice of. For your 20 people study to mean anything practically you will have to extrapolate your findings to the general public. While you may have achieved statistical significance for your limited question it does not allow you to extrapolate to a generalization. That way lies potential chaos.


One further thought: I've never used the needling technique so tell me if I'm missing the point, from what i understand you put a local anaesthetic in, then repeatedly stick a syringe needle into the lesion. Could you use a tattoo gun without any ink in it?

So here we have an 'ignorant person' designing a research project purely on a single gold standard protocol?

Sorry I expected better than that. Nurases work to protocals Dr use deductive reasoning.

Mark you surprise me I read your eloquent post the content was weak.

Robert I'm with you at least get some recorded information. Not perfect but better than naught.

Bob still waiting to be a grandpa.

 

Yeah, I'll loose sleep over that Bob.

I don't see what red blood cells have got to do with this discussion? You do your colleagues an injustice here, Bob. Many will get beyond the big words and pictures and critically evaluate the paper, even if you personally cannot and /or choose not to. Indeed, the paper may be used as an exercise in critical reading in an undergraduate syllabus.

Actually I'm a private practitioner, the same as you. How many subjects would you need so that you could "extrapolate to a generalisation"? Lets imagine I surveyed 200 people at lunch-time over a long lunch and they all thought you were a tosser and couldn't understand why I'm even bothering to engage in this with you. Does that mean that you are a tosser? What about if we surveyed 20,000 people and they all thought the same thing about you, is that a number that we can "extrapolate to a generalisation"?

Ignorant in terms of the fact that I have not performed the procedure does not prevent me from designing an adequate methodology, Bob.

And to re-iterate for the final time: You can perform whatever study protocol you like it will just provide you with a different level of evidence! But beware as soon as you publish a single case study, critical appraisal will follow and rightly so.

 

We considered a tattooing machine for the same reasons. However, the first few needling techniques I was involved with (either observing or administering) did not resolve the VP`s. We went back to the drawing board (the mosaic thread on here) and Steve Arbes had subsequently made the pertinent point that you have to puncture the VP `until there is no more resistance`. Henceforth, I have treated every VP as such and with great success. I don`t think you could achieve that with a tattoo machine, nor without LA. You have to literally `mash` the skin, drawing blood upon each stab!

 

Simon

I know you will not loose any sleep, and that is exactly why you sometimes come over as a tosser.

Why when you are challenged do you have to try and get personal?

While you think you are having a convincing logical argument with me I can assure you you are not.

Ok very juvenile RBC .

Like you I do not give a toss whether this study gets done, I can always quote KK and refer my patients to this site for conformation of how good needling is.

I'm sure I do my fellow practitioners an injustice believing they do not read the research, and yes I can see from your Podiatry pages you are just a PP.

You have a lot longer to work than me and I hope your practice thrithes.

I can understand your lack of enthusiasm over being presented with a VP to treat, as we all have the same feeling, F** all good treatments, F*** all evidence, f*** all guarantees, and the sinking feeling when they tell you how much they have spent on Wartner at the chemist.

The thing is Wartner is clinically proven to work.

And that is why they buy it. Just as GPs tell people with heel pain it's Plantar Faciitis go get some Vasyliis.

I repeat you pure researchers are doing a good job, shame the rest of the profession cannot say the same.

Now I see you advertise home visits, can I ask will you do them for anyone or like me restrict them to the housebound, and do you charge a premium over your surgery prices.

Bob. Daughter a molecular biologist PhD researcher has now done 22 hours in natural child birth and just accepted an epidural. She read all the book, problem is 'Quote a retired midwife, the babies have not'.

 

Hey Bob!

Is the birth imminent?

Keep us posted.

All the best
Bel

 

Bob, You asked me to provide some insight into research methodology, I have done that. Once it didn't fit with you mind-set you reverted to type and started with your cheap snipes again. You attempted the same thing with Paul Bowles the other day. I'm not prepared to play this callow game with you.

Goodbye.

 

Belinda

Bob. Daughter a molecular biologist PhD researcher has now done 22 hours in natural child birth and just accepted an epidural. She read all the book, problem is 'Quote a retired midwife, the babies have not'.

Thanks for the interest, but above says it all she is in the US we are in Cornwall.

Simon


Bob, You asked me to provide some insight into research methodology, I have done that. Once it didn't fit with you mind-set you reverted to type and started with your cheap snipes again. You attempted the same thing with Paul Bowles the other day. I'm not prepared to play this callow game with you.

Goodbye.

I think you should go back to the original post I did NOT ask you to provide some insight into research methodology until you chose to engage in this thread and debate with Robert I.

You have not really given much insight into research methodology only one method the gold standard.

Read again who started the cheap snipes, you will not notice them but it was you.

I ignored many of them but enough is enough.

Callow 'inexperienced and immature. Nice.

Sorry to see you go but I'm sure there are other mature researchers out there who are more secure in themselves and can lower their expectations to advance we ill educated.

Mr Golding

 

You can't tell, but I'm trying to defuse the tension by pulling funny faces.

.........


There.

Why can't we disagree without people taking umbrage?

Robert

 

You know, Bob, I'm sure you would be able to start a fight in a convent. Well out of order.