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my thoughts on the JAMA study

Posted by elliott on 10/01/02 at 10:34 (096596)

I have access to JAMA and read the actual Australian study in its entirety (I wish the docs here, who in general presumably have or could have easy access to journal articles than most of us here, would make such an effort and share their findings with us; it would cut down on unnecessary hysteria and speculation.) Here are some comments and thoughts.

COMMENTS

It seems to have been funded by local Australian diagnostic imaging groups; hopefully nothing too sinister about that.

The article stated the perceived weaknesses of previous trials, which for the Dornier FDA study were 1) PF diagnosis solely on clinical grounds, and 2) not describing their method of randomization, allocation concealment, or sample size calculation. The JAMA study included only those who had ultrasound-proven PF (any docs here care to comment on this?) as shown by PF thickening (but the EPOS was administered in exactly the same fashion as always, albeit with lower individual doses). Selection in the JAMA study was through random computer generation.

Orthotics/night splints as prescribed by the individual physicians were allowed in the JAMA study, but not much else.

THOUGHTS

Overall, the study seems to have been done quite carefully. Yes it is true that if a higher individual dose is the way to go, then this study won't pick that up, and yes, one can argue that the median of 6 months (with a minimum of only 6 weeks) was too short (even though they claim the longer-term patients showed no difference). Even if true, the study still adds value. Let's please put the article in its proper context, though not necessarily the same as the media's or others with agendas. There has been some debate and uncertainty as to how long to wait before supplying treatment, and also what is the ideal dose. The article acknowledges a higher does may be the way to go. But it also says that its 6-month median and dosage criteria were similar to other studies. Rather than cry foul that the JAMA study did not try to duplicate the FDA study, we could say that the JAMA study may help confirm in time that the single high dosage used in the Dornier FDA study is the way to go.

I'll add a few more points. Some may have reservations about using anesthesia for a control group. If one insists on not using it, the methods employed in the JAMA article seem to make more sense now, i.e. that explains the reason for increasing the dosage until minimum of {hurts the patient, pre-set maximum dosage} (I admit it is surprising in this context that the actives fared even worse in guessing their group than the controls).

It does discuss why a low dose rather than nothing was administered to the placebo group, namely to cover up the group allocation from the participants, a goal apparently achieved successfully. It points out that this was done similarly in the Rompe sudies.

I did find an error: in one place it says the median duration of symptoms was 36 weeks [that's 8 months and change] and 43 for the control [9 months and a lot of change], but elsewhere, when comparing the methodology to other studies, it says it was 6-7 months.

In summation, it seems to have been a carefully conducted study. I can't speak for the media hype or JAMA's intentions. The article does leave open that a higher dose could be the way to go.

Re: my thoughts on the JAMA study

Dr. Zuckerman on 10/01/02 at 14:19 (096606)

Here is one though. Who did the evaluations to determine the need for ESWT and the whether treatment was needed. Was it a radiologist ? DO you know Elliott

Re: my thoughts on the JAMA study

Ed Davis, DPM on 10/01/02 at 14:44 (096609)

Elliott:

Using plantar fascial thickness to diagnose PF is questionable at best. I think there first needs to be a study making a reasonable correlation between plantar fascial thickness and plantar fasciitis. I have seen patients with very thick plantar fascia but no symptoms of plantar fasciitis. Thickness is one POTENTIAL measure of tissue quality but a lot more need be studied before correlations can be made.
Ed

Re: my thoughts on the JAMA study

elliott on 10/01/02 at 15:12 (096615)

Dr. Z, I wish just once you'd thank me for taking the time to print stuff like this out for the board's benefit, which aids in a search for the truth. I'm trying to be objective in doing so. I mean, how credible would someone look if he rolled over dead and accepted without the slightest doubt any report that happens to enrich himself?

Here is a passage from the paper:

'Patients were recruited from the community-based referring physicians (primary care physicians, rheumatologists, orthopedic surgeons, and sports physicians) of Mayne Health Diagnostic Imaging in Melbourne, Australia. Radiologists evaluated all referred patients to ascertain eligibility criteria. The radiologists who asertained eligibility had no other involvement in the study...'

In case you're suggesting that radiologists were the 'primary' docs deciding if someone had PF, that doesn't appear so. The docs deciding their patients had PF were those listed in the first sentence of the preceding paragraph, who then referred them to the radiologists. The radiologists play a prominent role in this paper by necessity because they had to check for ultrasound-confirmed lesion as one of the eligibility criteria. You have a point (see, I'm objective) that they seem to be the final gatekeepers for satisfying the criteria, but that may be because checking for an ultrasound-confirmed lesion is the last step in the eligibility criteria process. If the radiologists might have their own agenda for either funding the study or which would lead one to believe the contents of the paper to be suspect, please state what that might be.

[[[[[

Re: you want a study? you got it!

elliott on 10/01/02 at 15:26 (096618)

A spanking new one, from everyone's favorite journal:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12237265&dopt=Abstract

I can readily accept that some have a thickened PF but are asymptomatic, just like some appear to have a bulging L4-L5 disc in their back but are asymptomatic. We're really asking is if it's a generally necessary, not sufficient condition, i.e., if one who has plantar fasciitis is more likely to have a thickened fascia.

[[[[[[[

Re: more: the paper's own cited studies

elliott on 10/01/02 at 15:54 (096620)

Here is a passage from the paper:

'We included participants with a clinical history compatible with PF as well as ultrasound criteria of thickening of the origin of the PF (>= 4 mm), hypoechogenicity, and alterations in the normal fibrillary pattern. These ultrasound criteria are in keeping with changes previously reported for PF on ultrasound examination (refs 45-51). Previous ESWT trials have either relied on clinical criteria alone (refs 22, 35) or required the presence of a calacaneal spur and positive bone scan (refs 19, 20).'

At risk of appearing to be a go-fetch-it dog (Carmen likes dogs!!), I managed to dig up 6 out of the 7 references (contained in 45-51) cited in the above paragraph lending support for a thickened fascia for those with PF:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10068071&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11561110&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10990224&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11028848&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9619897&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8816554&dopt=Abstract

[[[[[

Re: more: the paper's own cited studies

Ed Davis, DPM on 10/01/02 at 16:47 (096626)

Elliott:

Some of the studies have small numbers but looking at them cumulatively supports the correlation. One question to consider: What happens to plantar fascial thickness one PF is cured?

Thickness of the fascia represents a physiologic response to chronic excess tension on the fascia. Many individuals with chronic excess tension will have symptoms of plantar fasciitis but many will not. Again, consider the cured individual who still has thickened fascia.

I feel that the best selection criteria would include the presence of pain/tenderness plus thickening. The presence of thickening suggests that excess tension has been present on the fascia for an extended time, thus eliminating 'sprains' of the plantar fascia which is truly a different disease process.

ESWT is a tool to effect tissue quality which is a critical issue with intractable plantar fasciitis. How is tissue quality measured? I think that thickness of the fascia is one means. It is probably a reasonable assumption that the thicker fascia on ultrasound has more scar tissue, is less elastic and is more poorly vascularized. Biopsy would be necessary to confirm that though. I would like to see if Dr. Z has some observations on this but most of the patients I have seen with intractable plantar fasciitis whom I have performed ultrasound on have thicknesses at the origin of the plantar fascia of 8 to 11 mm. These numbers are significantly higher than those in the studies you have cited. Did the authors of the AMA paper list the average thickness of the plantar fascia of those included in the study or did they have a minimum criteria for thickness?
Ed

Re: more: the paper's own cited studies

RalphP on 10/01/02 at 21:25 (096658)

Well, I'm prompted by this discussion about thickness of the plantar fascia to ask the docs for some advice.

As I've posted before, I've had PF for 3 1/2 years, and also fibromyalgia for 20 years. I'd had ESWT scheduled, but then got advice from both Dr. Z and Dr. Gordon, the consultant to Bayshore, to get an ultrasound to see if the fascia had thickened, in order to determine whether it's normal PF or rather the FM talking. I had the ultrasound a few weeks ago, and the result was an average thickness of about 4 mm. My PF is bilateral but much worse on one side, but there was no difference in thickness between the two feet. From everything I'd heard, it sounded like I should take this as a negative indication -- thickness seemed a bit high but probably within the normal range, and no difference between the so-so foot and the bad foot. So I canceled the ESWT.

Questions:

--Are there any docs out there who think I should have gone through with the ESWT given these facts, or had further tests done before I decided?

--Should I even be treating this as a case of PF at this point, given that the painful fascia is not all that thick? Obviously it's possible that it's basically one more FM symptom, but I've treated it as PF because it behaves in just about every respect like garden variety PF.

One complicating factor: my immune system is highly abnormal. For example, for some 15 years I've consistently had a white blood cell count lower than about 99.9% of the population -- although I hardly ever get sick. So it might be that what I've got is basically a PF process but limited thickening of the fascia due to inability to mount the normal inflammatory healing response.

By the way, I want to thank Elliot for posting all the studies. I've found them to be highly informative and useful.

Re: more: the paper's own cited studies

Ed Davis, DPM on 10/01/02 at 21:45 (096659)

Ralph:

We have, for years before this current discussion, accurately diagnosed PF by clinical signs. I would not let the ultrasound studies override a diagnosis of PF. Fibromyalgia produces more generalized, low grade symptoms that tend to be migratory. So if a body part displays very consistent symptomatology I would stick with the diagnosis as opposed to attributing it to fibromyalgia.
Ed

Re: Dr Ed ?

Pete on 10/02/02 at 05:46 (096673)

So what are the clinical signs then, pain on palpating the heel ? Couldn't that be nerve entrapement as well ?

If ultrasound is not a useful diagnostic tool, then surely that applies to an MRI which Dr's on here regularly advocate patients obtaining at great cost.

I'm not having a go, and appreciate all the dr's comments, but sometimes the Dr's give conflicting advice. It has definitely been stated on this site that a thickened fascia is a very strong indicator of pf. You're now saying otherwise ?

Re: Cudos Elliot!

Scott D. on 10/02/02 at 07:20 (096679)

Elliot.. I think you bring up some excellent points on the JAMA study! Perhaps the end result will be that a single high-energy treatment will be recognized as the treatment of choice. I doubt that any of us would be unhappy with that finding.

You've certainly done your homework and have helped to enlighten those of us who see this as a long-term procedure as opposed to those looking for the short-term gain. Yes, it makes it more difficult for the time being to get insurance reimbursement for our patients, but there is significant data in the study to suggest that following the FDA protocol is the way to go! The early days of ESWL (for kidney stones) were much the same as this. Having gone through that process years ago I can tell you that information, no matter how biased, can always help if you choose to use it correctly.

Thank you!

Re: more: the paper's own cited studies

elliott on 10/02/02 at 07:53 (096680)

Dr. Ed, I'll reiterate that the study did in fact follow your suggestion as to the best selection criteria, limiting the subjects to those who had *both* pain/tenderness *and* thickening, not just one. That is one of their key points, that the addition of the thickening criteria may have led to a more carefully selected group of patients with true PF as compared with other studies; that they had far less favorable results than obtained in similar earlier low-energy studies is something to ponder. I guess the next step is a study combining a high-energy single dose with an clincally- and ultrasound-confirmed group.

You asked if the study gave the average thickness. Yes it did. It was 6.04 (SD 1.34) for the treatment group, 5.80 (SD 1.26) for the placebo group, which, according to those links, sounds high enough. There's loads of other data in the article, a lot more than one might typically expect from a JAMA entry.

[[[[

Re: more: the paper's own cited studies

john h on 10/02/02 at 09:20 (096698)

Elliott:Your URL's certainly educated me on the use of ultasound in diagnoising PF. It would seem clear to me that from those papers there is a use for this tool. I have had doctors tell me it was a waste of time and to date have still never had an ultrasound of the fascia.

Re: more: the paper's own cited studies

Ed Davis. DPM on 10/02/02 at 10:46 (096716)

John:

One question to ask when considering any test is... 'How will the outcome of this test affect my treatment program?' If the test would have no effect, then its usefulness is in question.
Ed

Re: Dr Ed ?

Ed Davis. DPM on 10/02/02 at 11:54 (096719)

Pete:

The cost of ultrasound is very modest compared to MRI, perhaps one-fourth to one-sixth of the cost. I know of very few doctors who use ultasound regularly for the diagnosis of plantar fasciitis. I am one of the relatively small but growing numbers of docs who have an in-office ultrasound machine but probably use it for about 5% of my plantar fasciitis patients.

PF is not just diagnosed by pain on palpation of the heel but by direct palpation of the fascia itself. Nerve entrapment has a very different presentation including numbness along the distribution of the entrapped nerve, not just at the place of entrapment. That said, there are a few possible exceptions, particularly when small sensory terminal branches are entrapped such as the medial calcaneal nerve or 'Baxter,s nerve' which is a branch off the lateral plantar nerve.

Medicine 'is an art, not a science' and as such, there will always be differing approaches to various problems and thus disagreement between docs.

We will be exploring the relationship between fascia thickness and PF a lot more in the coming years. Dr. Z will measure fascial thickness before and after ESWT. We still are learning on this one.
Ed

Re: more: the paper's own cited studies

Ed Davis. DPM on 10/02/02 at 12:39 (096721)

Elliott:
The problem of half of the group having pF less than 6 months aside, I would still be concerned about the thickness issue. Patients whom I see with recalcitrant, longstanding PF have thicknesses significantly greater.
Perhaps we need more data on what thickness is to be considered normal.

Here is another issue to ponder. A number of patients we see have 'heel spurs' visible on x-rays. We have long maintained that the 'spurs' were not actually the source of the pain but an indicator of lonstanding excess plantar fascial tension/traction on the periosteum of the calcaneus causing 'elongation' of the boney attachment of the fascia. Radiogaphic heel spurs are often an incidental finding. I would like to correlate the presence of heel spurs with plantar fascial thickening on ultrasound. In theory, the correlation should be strong because both groups have excess, longstanding plantar fascial tension. We know that it is possible to have lonstanding excess plantar fascial tension but no plantar fasciitis.

I would anticipate that there may be as many asymptomatic people walking around with thickened (but perhaps not pathologically thickened fascia) fascia as there are with asymptomatic heel spurs.
Ed

Re: Elliott., Pete

Ed Davis. DPM on 10/02/02 at 12:57 (096723)

Considering my last responses to both Elliott and Pete I would propose using the ultrasound finding of plantar fascial thickess to support the diagnosis of chronic plantar fasciitis but not as a primary diagnostic tool until we have more information. My impression is that thickness of the plantar fascia is proportional to the the degree of strain on the fascia and how long that strain has been present.
Ed

Re: more: the paper's own cited studies

elliott on 10/02/02 at 13:18 (096730)

I will admit there's one thing bothering me a bit (at least before reading the full articles), namely some possible circular reasoning: how do you know a patient has real not 'fake' PF one can correlate with the ultrasound-confirmed thickening without the possibly suspect clinical diagnosis itself?

[[]]

Re: Elliott., Pete

elliott on 10/02/02 at 13:47 (096731)

Dr. Ed: using the ultrasound finding of plantar fascial thickess to support the diagnosis of chronic plantar fasciitis but not as a primary diagnostic tool is really what the JAMA claim they did. Presumably, the articles in the links on thickening provide some basis for what they did. I wonder if there could be unintended consequences of such restrictions, e.g., that someone with PF thickening is less likely to be cured than another without it but who still has 'real' PF.

In your other post, you mention spurs. It may be worth pointing out that the presence of a calcaneal spur was one of the criteria for the Rompe study. You also may be interested to know that the JAMA study kept track of how many of its own subjects had spurs: 78% of the treatment group, 70% of the placebo group. So I guess that implies that around 3 out of 4 of those with clinically- and ultrasound-supported PF also have spurs.

Anyway, I guess where we're holding now is that any sane person would not trust results unless the study is, at the very least, unfunded, double-blind, randomized, placebo-controlled, ultrasound-confirmed, bone-scan confirmed, single-high-energy-dose...

:-)

Re: Elliot

Pete on 10/02/02 at 15:01 (096734)

I'm due to see a new pod at the end of the month, the info you have provided is very interesting and I will mention this with the pod. Thanks for your time on this.

The more knowledge we have, the better our chances of success.

Living in England I can tell you the knowledge of pod's over here is very mixed indeed.

Re: more: the paper's own cited studies

Ed Davis. DPM on 10/02/02 at 15:27 (096737)

Elliott:
Considering that ESWT is a means to treat tissue quality we have to make one more assumption --- a correlation between poor tissue quality and thickness. Unfortunately we have no practical means of measuring tissue quality. We are assuming that plantar fascia which is overly thickened has poor tissue quality but this assumption cannot be backed up.
Ed

Re: more: the paper's own cited studies

elliott on 10/02/02 at 20:04 (096754)

Well, it might turn out to be a useful indicator as to whether to opt for expensive ESWT treatment.

Re: Dr Ed ?

john h on 10/03/02 at 09:04 (096790)

Dr. Ed: what is the typical cost for an ultrasound to measure fascia thickness? You would think that there would have been studies done over the years on comparative thickness of the fascia due to age and or disease. It would also seem than somone would have done some studies on cadavers on tissue quality of the fascia of people with chronic PF. Since 3-6 million new cases a year are reported this is a disease with both economic and very emotional consequences this is no small matter.

Re: more: the paper's own cited studies

john h on 10/03/02 at 09:13 (096793)

Dr. Ed you are correct but with PF the diagnosis seems to be always in question. Note the vast number of people on this board who are looking at other possible causes for their foot pain. Anything that can help clearly diagnois PF would seem welcome. From the URL;s that Elliott posted it seemed there was a clear correlation between PF and a thickend fascia. Of course this is just another tool and will not confirm PF it would seem to add to the equation,. especially with chronic patients who are wondering about the quality of their diagnosis. I have been to to many Doctors to remember and no one has ever done an ultrasond or MRI. Ond Doctor stated that an ultrasound was a waste of money which flys in the face of some of the studies that Elliott posted.If an ultrasound is on a couple hundred dollars I would gladly pay it out of my pocket.

Re: john h

elliott on 10/03/02 at 10:29 (096799)

These may or may not be of interest to you:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11561110&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11387107&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11266484&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11030509&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9771217&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8816554&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8253440&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11046170&dopt=Abstract

[[[[[[[

Re: my thoughts on the JAMA study

Dr. Zuckerman on 10/03/02 at 11:41 (096806)

Thanks

Re: now I feel better :-) (nm)

elliott on 10/03/02 at 13:07 (096812)

.

Re: my thoughts on the JAMA study

Dr. Zuckerman on 10/01/02 at 14:19 (096606)

Here is one though. Who did the evaluations to determine the need for ESWT and the whether treatment was needed. Was it a radiologist ? DO you know Elliott

Re: my thoughts on the JAMA study

Ed Davis, DPM on 10/01/02 at 14:44 (096609)

Elliott:

Using plantar fascial thickness to diagnose PF is questionable at best. I think there first needs to be a study making a reasonable correlation between plantar fascial thickness and plantar fasciitis. I have seen patients with very thick plantar fascia but no symptoms of plantar fasciitis. Thickness is one POTENTIAL measure of tissue quality but a lot more need be studied before correlations can be made.
Ed

Re: my thoughts on the JAMA study

elliott on 10/01/02 at 15:12 (096615)

Dr. Z, I wish just once you'd thank me for taking the time to print stuff like this out for the board's benefit, which aids in a search for the truth. I'm trying to be objective in doing so. I mean, how credible would someone look if he rolled over dead and accepted without the slightest doubt any report that happens to enrich himself?

Here is a passage from the paper:

'Patients were recruited from the community-based referring physicians (primary care physicians, rheumatologists, orthopedic surgeons, and sports physicians) of Mayne Health Diagnostic Imaging in Melbourne, Australia. Radiologists evaluated all referred patients to ascertain eligibility criteria. The radiologists who asertained eligibility had no other involvement in the study...'

In case you're suggesting that radiologists were the 'primary' docs deciding if someone had PF, that doesn't appear so. The docs deciding their patients had PF were those listed in the first sentence of the preceding paragraph, who then referred them to the radiologists. The radiologists play a prominent role in this paper by necessity because they had to check for ultrasound-confirmed lesion as one of the eligibility criteria. You have a point (see, I'm objective) that they seem to be the final gatekeepers for satisfying the criteria, but that may be because checking for an ultrasound-confirmed lesion is the last step in the eligibility criteria process. If the radiologists might have their own agenda for either funding the study or which would lead one to believe the contents of the paper to be suspect, please state what that might be.

[[[[[

Re: you want a study? you got it!

elliott on 10/01/02 at 15:26 (096618)

A spanking new one, from everyone's favorite journal:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12237265&dopt=Abstract

I can readily accept that some have a thickened PF but are asymptomatic, just like some appear to have a bulging L4-L5 disc in their back but are asymptomatic. We're really asking is if it's a generally necessary, not sufficient condition, i.e., if one who has plantar fasciitis is more likely to have a thickened fascia.

[[[[[[[

Re: more: the paper's own cited studies

elliott on 10/01/02 at 15:54 (096620)

Here is a passage from the paper:

'We included participants with a clinical history compatible with PF as well as ultrasound criteria of thickening of the origin of the PF (>= 4 mm), hypoechogenicity, and alterations in the normal fibrillary pattern. These ultrasound criteria are in keeping with changes previously reported for PF on ultrasound examination (refs 45-51). Previous ESWT trials have either relied on clinical criteria alone (refs 22, 35) or required the presence of a calacaneal spur and positive bone scan (refs 19, 20).'

At risk of appearing to be a go-fetch-it dog (Carmen likes dogs!!), I managed to dig up 6 out of the 7 references (contained in 45-51) cited in the above paragraph lending support for a thickened fascia for those with PF:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10068071&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11561110&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=10990224&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11028848&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9619897&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8816554&dopt=Abstract

[[[[[

Re: more: the paper's own cited studies

Ed Davis, DPM on 10/01/02 at 16:47 (096626)

Elliott:

Some of the studies have small numbers but looking at them cumulatively supports the correlation. One question to consider: What happens to plantar fascial thickness one PF is cured?

Thickness of the fascia represents a physiologic response to chronic excess tension on the fascia. Many individuals with chronic excess tension will have symptoms of plantar fasciitis but many will not. Again, consider the cured individual who still has thickened fascia.

I feel that the best selection criteria would include the presence of pain/tenderness plus thickening. The presence of thickening suggests that excess tension has been present on the fascia for an extended time, thus eliminating 'sprains' of the plantar fascia which is truly a different disease process.

ESWT is a tool to effect tissue quality which is a critical issue with intractable plantar fasciitis. How is tissue quality measured? I think that thickness of the fascia is one means. It is probably a reasonable assumption that the thicker fascia on ultrasound has more scar tissue, is less elastic and is more poorly vascularized. Biopsy would be necessary to confirm that though. I would like to see if Dr. Z has some observations on this but most of the patients I have seen with intractable plantar fasciitis whom I have performed ultrasound on have thicknesses at the origin of the plantar fascia of 8 to 11 mm. These numbers are significantly higher than those in the studies you have cited. Did the authors of the AMA paper list the average thickness of the plantar fascia of those included in the study or did they have a minimum criteria for thickness?
Ed

Re: more: the paper's own cited studies

RalphP on 10/01/02 at 21:25 (096658)

Well, I'm prompted by this discussion about thickness of the plantar fascia to ask the docs for some advice.

As I've posted before, I've had PF for 3 1/2 years, and also fibromyalgia for 20 years. I'd had ESWT scheduled, but then got advice from both Dr. Z and Dr. Gordon, the consultant to Bayshore, to get an ultrasound to see if the fascia had thickened, in order to determine whether it's normal PF or rather the FM talking. I had the ultrasound a few weeks ago, and the result was an average thickness of about 4 mm. My PF is bilateral but much worse on one side, but there was no difference in thickness between the two feet. From everything I'd heard, it sounded like I should take this as a negative indication -- thickness seemed a bit high but probably within the normal range, and no difference between the so-so foot and the bad foot. So I canceled the ESWT.

Questions:

--Are there any docs out there who think I should have gone through with the ESWT given these facts, or had further tests done before I decided?

--Should I even be treating this as a case of PF at this point, given that the painful fascia is not all that thick? Obviously it's possible that it's basically one more FM symptom, but I've treated it as PF because it behaves in just about every respect like garden variety PF.

One complicating factor: my immune system is highly abnormal. For example, for some 15 years I've consistently had a white blood cell count lower than about 99.9% of the population -- although I hardly ever get sick. So it might be that what I've got is basically a PF process but limited thickening of the fascia due to inability to mount the normal inflammatory healing response.

By the way, I want to thank Elliot for posting all the studies. I've found them to be highly informative and useful.

Re: more: the paper's own cited studies

Ed Davis, DPM on 10/01/02 at 21:45 (096659)

Ralph:

We have, for years before this current discussion, accurately diagnosed PF by clinical signs. I would not let the ultrasound studies override a diagnosis of PF. Fibromyalgia produces more generalized, low grade symptoms that tend to be migratory. So if a body part displays very consistent symptomatology I would stick with the diagnosis as opposed to attributing it to fibromyalgia.
Ed

Re: Dr Ed ?

Pete on 10/02/02 at 05:46 (096673)

So what are the clinical signs then, pain on palpating the heel ? Couldn't that be nerve entrapement as well ?

If ultrasound is not a useful diagnostic tool, then surely that applies to an MRI which Dr's on here regularly advocate patients obtaining at great cost.

I'm not having a go, and appreciate all the dr's comments, but sometimes the Dr's give conflicting advice. It has definitely been stated on this site that a thickened fascia is a very strong indicator of pf. You're now saying otherwise ?

Re: Cudos Elliot!

Scott D. on 10/02/02 at 07:20 (096679)

Elliot.. I think you bring up some excellent points on the JAMA study! Perhaps the end result will be that a single high-energy treatment will be recognized as the treatment of choice. I doubt that any of us would be unhappy with that finding.

You've certainly done your homework and have helped to enlighten those of us who see this as a long-term procedure as opposed to those looking for the short-term gain. Yes, it makes it more difficult for the time being to get insurance reimbursement for our patients, but there is significant data in the study to suggest that following the FDA protocol is the way to go! The early days of ESWL (for kidney stones) were much the same as this. Having gone through that process years ago I can tell you that information, no matter how biased, can always help if you choose to use it correctly.

Thank you!

Re: more: the paper's own cited studies

elliott on 10/02/02 at 07:53 (096680)

Dr. Ed, I'll reiterate that the study did in fact follow your suggestion as to the best selection criteria, limiting the subjects to those who had *both* pain/tenderness *and* thickening, not just one. That is one of their key points, that the addition of the thickening criteria may have led to a more carefully selected group of patients with true PF as compared with other studies; that they had far less favorable results than obtained in similar earlier low-energy studies is something to ponder. I guess the next step is a study combining a high-energy single dose with an clincally- and ultrasound-confirmed group.

You asked if the study gave the average thickness. Yes it did. It was 6.04 (SD 1.34) for the treatment group, 5.80 (SD 1.26) for the placebo group, which, according to those links, sounds high enough. There's loads of other data in the article, a lot more than one might typically expect from a JAMA entry.

[[[[

Re: more: the paper's own cited studies

john h on 10/02/02 at 09:20 (096698)

Elliott:Your URL's certainly educated me on the use of ultasound in diagnoising PF. It would seem clear to me that from those papers there is a use for this tool. I have had doctors tell me it was a waste of time and to date have still never had an ultrasound of the fascia.

Re: more: the paper's own cited studies

Ed Davis. DPM on 10/02/02 at 10:46 (096716)

John:

One question to ask when considering any test is... 'How will the outcome of this test affect my treatment program?' If the test would have no effect, then its usefulness is in question.
Ed

Re: Dr Ed ?

Ed Davis. DPM on 10/02/02 at 11:54 (096719)

Pete:

The cost of ultrasound is very modest compared to MRI, perhaps one-fourth to one-sixth of the cost. I know of very few doctors who use ultasound regularly for the diagnosis of plantar fasciitis. I am one of the relatively small but growing numbers of docs who have an in-office ultrasound machine but probably use it for about 5% of my plantar fasciitis patients.

PF is not just diagnosed by pain on palpation of the heel but by direct palpation of the fascia itself. Nerve entrapment has a very different presentation including numbness along the distribution of the entrapped nerve, not just at the place of entrapment. That said, there are a few possible exceptions, particularly when small sensory terminal branches are entrapped such as the medial calcaneal nerve or 'Baxter,s nerve' which is a branch off the lateral plantar nerve.

Medicine 'is an art, not a science' and as such, there will always be differing approaches to various problems and thus disagreement between docs.

We will be exploring the relationship between fascia thickness and PF a lot more in the coming years. Dr. Z will measure fascial thickness before and after ESWT. We still are learning on this one.
Ed

Re: more: the paper's own cited studies

Ed Davis. DPM on 10/02/02 at 12:39 (096721)

Elliott:
The problem of half of the group having pF less than 6 months aside, I would still be concerned about the thickness issue. Patients whom I see with recalcitrant, longstanding PF have thicknesses significantly greater.
Perhaps we need more data on what thickness is to be considered normal.

Here is another issue to ponder. A number of patients we see have 'heel spurs' visible on x-rays. We have long maintained that the 'spurs' were not actually the source of the pain but an indicator of lonstanding excess plantar fascial tension/traction on the periosteum of the calcaneus causing 'elongation' of the boney attachment of the fascia. Radiogaphic heel spurs are often an incidental finding. I would like to correlate the presence of heel spurs with plantar fascial thickening on ultrasound. In theory, the correlation should be strong because both groups have excess, longstanding plantar fascial tension. We know that it is possible to have lonstanding excess plantar fascial tension but no plantar fasciitis.

I would anticipate that there may be as many asymptomatic people walking around with thickened (but perhaps not pathologically thickened fascia) fascia as there are with asymptomatic heel spurs.
Ed

Re: Elliott., Pete

Ed Davis. DPM on 10/02/02 at 12:57 (096723)

Considering my last responses to both Elliott and Pete I would propose using the ultrasound finding of plantar fascial thickess to support the diagnosis of chronic plantar fasciitis but not as a primary diagnostic tool until we have more information. My impression is that thickness of the plantar fascia is proportional to the the degree of strain on the fascia and how long that strain has been present.
Ed

Re: more: the paper's own cited studies

elliott on 10/02/02 at 13:18 (096730)

I will admit there's one thing bothering me a bit (at least before reading the full articles), namely some possible circular reasoning: how do you know a patient has real not 'fake' PF one can correlate with the ultrasound-confirmed thickening without the possibly suspect clinical diagnosis itself?

[[]]

Re: Elliott., Pete

elliott on 10/02/02 at 13:47 (096731)

Dr. Ed: using the ultrasound finding of plantar fascial thickess to support the diagnosis of chronic plantar fasciitis but not as a primary diagnostic tool is really what the JAMA claim they did. Presumably, the articles in the links on thickening provide some basis for what they did. I wonder if there could be unintended consequences of such restrictions, e.g., that someone with PF thickening is less likely to be cured than another without it but who still has 'real' PF.

In your other post, you mention spurs. It may be worth pointing out that the presence of a calcaneal spur was one of the criteria for the Rompe study. You also may be interested to know that the JAMA study kept track of how many of its own subjects had spurs: 78% of the treatment group, 70% of the placebo group. So I guess that implies that around 3 out of 4 of those with clinically- and ultrasound-supported PF also have spurs.

Anyway, I guess where we're holding now is that any sane person would not trust results unless the study is, at the very least, unfunded, double-blind, randomized, placebo-controlled, ultrasound-confirmed, bone-scan confirmed, single-high-energy-dose...

:-)

Re: Elliot

Pete on 10/02/02 at 15:01 (096734)

I'm due to see a new pod at the end of the month, the info you have provided is very interesting and I will mention this with the pod. Thanks for your time on this.

The more knowledge we have, the better our chances of success.

Living in England I can tell you the knowledge of pod's over here is very mixed indeed.

Re: more: the paper's own cited studies

Ed Davis. DPM on 10/02/02 at 15:27 (096737)

Elliott:
Considering that ESWT is a means to treat tissue quality we have to make one more assumption --- a correlation between poor tissue quality and thickness. Unfortunately we have no practical means of measuring tissue quality. We are assuming that plantar fascia which is overly thickened has poor tissue quality but this assumption cannot be backed up.
Ed

Re: more: the paper's own cited studies

elliott on 10/02/02 at 20:04 (096754)

Well, it might turn out to be a useful indicator as to whether to opt for expensive ESWT treatment.

Re: Dr Ed ?

john h on 10/03/02 at 09:04 (096790)

Dr. Ed: what is the typical cost for an ultrasound to measure fascia thickness? You would think that there would have been studies done over the years on comparative thickness of the fascia due to age and or disease. It would also seem than somone would have done some studies on cadavers on tissue quality of the fascia of people with chronic PF. Since 3-6 million new cases a year are reported this is a disease with both economic and very emotional consequences this is no small matter.

Re: more: the paper's own cited studies

john h on 10/03/02 at 09:13 (096793)

Dr. Ed you are correct but with PF the diagnosis seems to be always in question. Note the vast number of people on this board who are looking at other possible causes for their foot pain. Anything that can help clearly diagnois PF would seem welcome. From the URL;s that Elliott posted it seemed there was a clear correlation between PF and a thickend fascia. Of course this is just another tool and will not confirm PF it would seem to add to the equation,. especially with chronic patients who are wondering about the quality of their diagnosis. I have been to to many Doctors to remember and no one has ever done an ultrasond or MRI. Ond Doctor stated that an ultrasound was a waste of money which flys in the face of some of the studies that Elliott posted.If an ultrasound is on a couple hundred dollars I would gladly pay it out of my pocket.

Re: john h

elliott on 10/03/02 at 10:29 (096799)

These may or may not be of interest to you:

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11561110&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11387107&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11266484&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11030509&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=9771217&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8816554&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=8253440&dopt=Abstract

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11046170&dopt=Abstract

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Re: my thoughts on the JAMA study

Dr. Zuckerman on 10/03/02 at 11:41 (096806)

Thanks

Re: now I feel better :-) (nm)

elliott on 10/03/02 at 13:07 (096812)

.