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Does the face-validity test mean nothing anymore?
Started by au bon pain
Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy - PubMed
The antibiotic protocol in this study was significantly more effective for this group of patients (CLBP associated with Modic I) than placebo in all the primary and secondary outcomes.
pubmed.ncbi.nlm.nih.gov
Not the first rodeo.
Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy - PubMed
The antibiotic protocol in this study was significantly more effective for this group of patients (CLBP associated with Modic I) than placebo in all the primary and secondary outcomes.
Not the first rodeo.
lol fair fair
But my question still stands
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Nah, some egg head wants to make their career on the idea and can jump through enough hoops to make it sound science-y.
Didn't you hear about the P.acnes with sciatica?
Don't you know that vacuum discs suggest gas forming bacteria in the end plates?
Honestly, EBM and 'snake oil' are both guilty of this. Lets not get @mille125 and @Ducttape arguing about it, but pain medicine has a significant dearth of face validity as we have a subjective phenotype that is changed by bio/pyscho/social variables we don't fully understand.
We can't even agree that if a bone is broken, someone should fix it.
To be clear I am not an opponent of EBM. I think that it has advanced medicine and is quite useful.
I do disagree with referring to anything that doesn't have the backing of RCTs as "snake oil". If that was true, then all of us are snake oil salesman, Ducttape included.
I am also an opponent of using it the way that Ducttape suggests which is EBM overtakes all other considerations even though it is clear that EBM is based on populations instead of individuals (many times homogenous single sex populations). He has said if there isn't evidence go get some. In a utopia that would be great but in the USA specifically the only way to fund the kind of studies that he deems are "worthy" is to have a device or a pharmaceutical companies involved. Some evolving treatments have no way to enrich either of these constituencies and therefore have no way of getting funded.
i wasnt going to respond, but your claims regarding EBM forced my hand.
the scientific method is one of postulating a hypothesis, testing that hypothesis, and then advancing a theory based on confirming the hypothesis. EBM is testing these hypotheses. without EBM, you have snake oil. with EBM, you have at least started to confirm the hypothesis. with quality and reproduced EBM, you have a theory.
we should be using EBM to advance medicine. saying "no one is going to pay for these studies" is a cop out, because it is bypassing science to sell treatments without proven efficacy and analysis of potential harm.
look at all the "treatments" we previously had for pain that have fallen by the wayside. there are too many. yes you can lump treatments such as ESI or TPI, but the evidence in these treatments are conflicting, and most likely there is a specific subset of patients where these procedures are beneficial and others that do not.
interest in possible infections of the disc have been present for a long time. the earliest mention i saw in a quick pubmed search was 2001, with propionibacterium acnes. and in truth, it was for discogenic back pain. in one study, oral antibiotics were given for patients with Modic Type 1 changes way before Intracept was studied. it suggested that 100 days of antibiotics provided clinically significant benefit.
pubmed.ncbi.nlm.nih.gov
now that has not become standard of care because of EBM - other studies have shown no benefit, including this one. i also suspect this did not become our standard of care because the study was done in Europe and because there is poor financial reimbursement to giving 100 days of antibiotics vs a series of 3.
but in your world, we should be prescribing 100 days of antibiotics orally or intradiscally for patients with Modic 1 changes, just because "Im the doctor and I said so", which - based on numerous studies - would not have helped, would have caused significant antibiotic resistance and/or even possibly infection itself from the intradiscal injections.
the scientific method is one of postulating a hypothesis, testing that hypothesis, and then advancing a theory based on confirming the hypothesis. EBM is testing these hypotheses. without EBM, you have snake oil. with EBM, you have at least started to confirm the hypothesis. with quality and reproduced EBM, you have a theory.
we should be using EBM to advance medicine. saying "no one is going to pay for these studies" is a cop out, because it is bypassing science to sell treatments without proven efficacy and analysis of potential harm.
look at all the "treatments" we previously had for pain that have fallen by the wayside. there are too many. yes you can lump treatments such as ESI or TPI, but the evidence in these treatments are conflicting, and most likely there is a specific subset of patients where these procedures are beneficial and others that do not.
interest in possible infections of the disc have been present for a long time. the earliest mention i saw in a quick pubmed search was 2001, with propionibacterium acnes. and in truth, it was for discogenic back pain. in one study, oral antibiotics were given for patients with Modic Type 1 changes way before Intracept was studied. it suggested that 100 days of antibiotics provided clinically significant benefit.
Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy - PubMed
The antibiotic protocol in this study was significantly more effective for this group of patients (CLBP associated with Modic I) than placebo in all the primary and secondary outcomes.
pubmed.ncbi.nlm.nih.gov
now that has not become standard of care because of EBM - other studies have shown no benefit, including this one. i also suspect this did not become our standard of care because the study was done in Europe and because there is poor financial reimbursement to giving 100 days of antibiotics vs a series of 3.
but in your world, we should be prescribing 100 days of antibiotics orally or intradiscally for patients with Modic 1 changes, just because "Im the doctor and I said so", which - based on numerous studies - would not have helped, would have caused significant antibiotic resistance and/or even possibly infection itself from the intradiscal injections.
I love how even a mundane post about a dumb topic (a special talent of mine) can reliably reignite old beefs on this forum.
This is why I keep coming back
This is why I keep coming back
Is the practice of medicine an art or a science?i wasnt going to respond, but your claims regarding EBM forced my hand.
the scientific method is one of postulating a hypothesis, testing that hypothesis, and then advancing a theory based on confirming the hypothesis. EBM is testing these hypotheses. without EBM, you have snake oil. with EBM, you have at least started to confirm the hypothesis. with quality and reproduced EBM, you have a theory.
we should be using EBM to advance medicine. saying "no one is going to pay for these studies" is a cop out, because it is bypassing science to sell treatments without proven efficacy and analysis of potential harm.
look at all the "treatments" we previously had for pain that have fallen by the wayside. there are too many. yes you can lump treatments such as ESI or TPI, but the evidence in these treatments are conflicting, and most likely there is a specific subset of patients where these procedures are beneficial and others that do not.
interest in possible infections of the disc have been present for a long time. the earliest mention i saw in a quick pubmed search was 2001, with propionibacterium acnes. and in truth, it was for discogenic back pain. in one study, oral antibiotics were given for patients with Modic Type 1 changes way before Intracept was studied. it suggested that 100 days of antibiotics provided clinically significant benefit.
Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy - PubMed
The antibiotic protocol in this study was significantly more effective for this group of patients (CLBP associated with Modic I) than placebo in all the primary and secondary outcomes.
now that has not become standard of care because of EBM - other studies have shown no benefit, including this one. i also suspect this did not become our standard of care because the study was done in Europe and because there is poor financial reimbursement to giving 100 days of antibiotics vs a series of 3.
but in your world, we should be prescribing 100 days of antibiotics orally or intradiscally for patients with Modic 1 changes, just because "Im the doctor and I said so", which - based on numerous studies - would not have helped, would have caused significant antibiotic resistance and/or even possibly infection itself from the intradiscal injections.
i wasnt going to respond, but your claims regarding EBM forced my hand.
the scientific method is one of postulating a hypothesis, testing that hypothesis, and then advancing a theory based on confirming the hypothesis. EBM is testing these hypotheses. without EBM, you have snake oil. with EBM, you have at least started to confirm the hypothesis. with quality and reproduced EBM, you have a theory.
we should be using EBM to advance medicine. saying "no one is going to pay for these studies" is a cop out, because it is bypassing science to sell treatments without proven efficacy and analysis of potential harm.
look at all the "treatments" we previously had for pain that have fallen by the wayside. there are too many. yes you can lump treatments such as ESI or TPI, but the evidence in these treatments are conflicting, and most likely there is a specific subset of patients where these procedures are beneficial and others that do not.
interest in possible infections of the disc have been present for a long time. the earliest mention i saw in a quick pubmed search was 2001, with propionibacterium acnes. and in truth, it was for discogenic back pain. in one study, oral antibiotics were given for patients with Modic Type 1 changes way before Intracept was studied. it suggested that 100 days of antibiotics provided clinically significant benefit.
Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy - PubMed
The antibiotic protocol in this study was significantly more effective for this group of patients (CLBP associated with Modic I) than placebo in all the primary and secondary outcomes.
now that has not become standard of care because of EBM - other studies have shown no benefit, including this one. i also suspect this did not become our standard of care because the study was done in Europe and because there is poor financial reimbursement to giving 100 days of antibiotics vs a series of 3.
but in your world, we should be prescribing 100 days of antibiotics orally or intradiscally for patients with Modic 1 changes, just because "Im the doctor and I said so", which - based on numerous studies - would not have helped, would have caused significant antibiotic resistance and/or even possibly infection itself from the intradiscal injections.
The other mistake that you make in my opinion is grouping all treatments together as if they are equal.
100 days of antibiotics has a not low risk of drug reaction as well as antibiotic resistance for the. population. I just saw a patient last week with permanent ligamentous damage from quinolones.
You mention intradiscal injections and intracept. Each has low but serious risks. I have served as a defense witness to some.
Compare that to MLS laser therapy , shockwave or even scrambler. There is as close to zero risk other than self limiting local skin irtitation.irritation.
These are not the same and honestly there is much better evidence in the latter group compared to the former.
The fact of the matter is that there are greater than 6 RCTs on EACH of these treatments. You say even that isn't good enough. If you reject those RCTs then you must also reject every single pain procedure that we do if you are being consistent because the 'evidence" is not even close. Maybe you do. I dunno anymore.
the "art" of medicine is providing treatments to patients that are grounded on EBM as its foundation. medicine is a science first with art overlain. if it were just an art, then physicians would essentially be chiros by a different name.
we have reviewed your "greater than 6 RCTs" in different posts and the sample size and the quality of the data are small, especially compared to EBM from other specialties such as IM.
i would give additional credit to those therapies if it came from an unbiased source, but the individuals touting these alternative therapies almost always the ones benefiting from giving patient$ the$e treatment$.
we have reviewed your "greater than 6 RCTs" in different posts and the sample size and the quality of the data are small, especially compared to EBM from other specialties such as IM.
i would give additional credit to those therapies if it came from an unbiased source, but the individuals touting these alternative therapies almost always the ones benefiting from giving patient$ the$e treatment$.
As I said before, no one is lining up to run RCTs on therapies that cannot be monetized by pharmaceutical or device patents, at least in the US. Major medical centers like Hopkins have recent papers on scrambler for CIPN. I assume this is unbiased to you but I guess I shouldnt assume.
We can go around and around which is pointless and we should just agree to disagree.
.
My final ask...show me an RCT or group of RCTs that you deem as adequate and useful for your interventional practice that holds up to the level of scrutiny that you apply here.
Then we can stop.
We can go around and around which is pointless and we should just agree to disagree.
.
My final ask...show me an RCT or group of RCTs that you deem as adequate and useful for your interventional practice that holds up to the level of scrutiny that you apply here.
Then we can stop.
That argument doesn’t hold water to me in this case. The manufacturer is charging something like $60,000 for the scrambler device aren’t they? It’s treating neuropathic pain with a proprietary algorithm of stimulation. Huge population to choose from and you could pretty easily have a tech hook the patient up and the patient gives feedback on what they are feeling, while a doctor in the other room who doesn’t directly talk to the patient makes adjustments to the machine. Placebo stim gets something like a TENS unit effect outside of the scrambler frequencies, and the doctor’s adjustments change the feel a bit but aren’t like scrambler. Then a blinded research nurse assesses their pain response ongoing during and after treatment. It isn’t some huge pharmacological study where you have to spend millions on safety monitoring. It would probably cost at most $200,000, most of that being the doctor’s time.
Kypho article from Lobel et al.... metanalyses including RCTs.
That assumes that TENS is placebo.
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You are also assuming that trials and RCTs are not there. They are and they have been done at Hopkins, UCLA, and several European centers.
Ducttape just rejects them but somehow feels that the evidence in the pain literature for the things that we do is better.
I just don't understand that.
Attachments
there are 15 articles on pubmed in the last 3 years. case reports, a review, 2 meta-analyses, a pilot study, 1 study on post stroke pain.
the one study from hopkins was the post stroke study with 20 patients.
hopkins is a certified Calmware site.
examples:
meta-analysis
Bisphosphonate treatment is associated with decreased mortality rates in patients after osteoporotic vertebral fracture - Osteoporosis International
Summary The aim of this study is to investigate the effect of bisphosphonate (BP) on mortality after osteoporotic vertebral fracture (OVF). BP medication (hazard ratios = 0.593; 95%CI: 0.361–0.976) was significantly associated with reduced all-cause mortality after OVF. Purpose Osteoporotic...
link.springer.com
Randomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group - PubMed
We conclude that among women with low bone mass and existing vertebral fractures, alendronate is well tolerated and substantially reduces the frequency of morphometric and clinical vertebral fractures, as well as other clinical fractures.
pubmed.ncbi.nlm.nih.gov
Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults - PubMed
The HZ/su vaccine significantly reduced the risk of herpes zoster in adults who were 50 years of age or older. Vaccine efficacy in adults who were 70 years of age or older was similar to that in the other two age groups. (Funded by GlaxoSmithKline Biologicals; ZOE-50 ClinicalTrials.gov number...
pubmed.ncbi.nlm.nih.gov
Impact of temperature on the magnitude and duration of relief after lumbar facets medial branch nerves radiofrequency ablation: a randomized double-blinded study - PubMed
RFA has been demonstrated as an effective therapeutic modality for lumbar facetogenic back pain. Yet, the several factors involved in determining a favorable outcome of this procedure require further research and optimization. This prospective double-blinded randomized trial demonstrated that...
pubmed.ncbi.nlm.nih.gov
but i have to get back to work...
They are certified calmare meaning that they have a machine ans got the training on how to use it.there are 15 articles on pubmed in the last 3 years. case reports, a review, 2 meta-analyses, a pilot study, 1 study on post stroke pain.
the one study from hopkins was the post stroke study with 20 patients.
hopkins is a certified Calmware site.
examples:
meta-analysis
only 164 subjects but clinically significant reduction of mortality after VCF with bisphophonatesBisphosphonate treatment is associated with decreased mortality rates in patients after osteoporotic vertebral fracture - Osteoporosis International
Summary The aim of this study is to investigate the effect of bisphosphonate (BP) on mortality after osteoporotic vertebral fracture (OVF). BP medication (hazard ratios = 0.593; 95%CI: 0.361–0.976) was significantly associated with reduced all-cause mortality after OVF. Purpose Osteoporotic...
original FIT trialRandomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group - PubMed
We conclude that among women with low bone mass and existing vertebral fractures, alendronate is well tolerated and substantially reduces the frequency of morphometric and clinical vertebral fractures, as well as other clinical fractures.
shingles vaccine efficacyEfficacy of an adjuvanted herpes zoster subunit vaccine in older adults - PubMed
The HZ/su vaccine significantly reduced the risk of herpes zoster in adults who were 50 years of age or older. Vaccine efficacy in adults who were 70 years of age or older was similar to that in the other two age groups. (Funded by GlaxoSmithKline Biologicals; ZOE-50 ClinicalTrials.gov number...
HPV vaccine efficacy
RFA temp influences time to repeat. small study but looks powered enoughImpact of temperature on the magnitude and duration of relief after lumbar facets medial branch nerves radiofrequency ablation: a randomized double-blinded study - PubMed
RFA has been demonstrated as an effective therapeutic modality for lumbar facetogenic back pain. Yet, the several factors involved in determining a favorable outcome of this procedure require further research and optimization. This prospective double-blinded randomized trial demonstrated that...
but i have to get back to work...
You do need a machine to do studies, correct?
So based in this, you offer RFA and nothing else, correct?
I haven't read thoroughly but the RFA study was in different Temps not on if RFA is effective.there are 15 articles on pubmed in the last 3 years. case reports, a review, 2 meta-analyses, a pilot study, 1 study on post stroke pain.
the one study from hopkins was the post stroke study with 20 patients.
hopkins is a certified Calmware site.
examples:
meta-analysis
only 164 subjects but clinically significant reduction of mortality after VCF with bisphophonatesBisphosphonate treatment is associated with decreased mortality rates in patients after osteoporotic vertebral fracture - Osteoporosis International
Summary The aim of this study is to investigate the effect of bisphosphonate (BP) on mortality after osteoporotic vertebral fracture (OVF). BP medication (hazard ratios = 0.593; 95%CI: 0.361–0.976) was significantly associated with reduced all-cause mortality after OVF. Purpose Osteoporotic...
original FIT trialRandomised trial of effect of alendronate on risk of fracture in women with existing vertebral fractures. Fracture Intervention Trial Research Group - PubMed
We conclude that among women with low bone mass and existing vertebral fractures, alendronate is well tolerated and substantially reduces the frequency of morphometric and clinical vertebral fractures, as well as other clinical fractures.
shingles vaccine efficacyEfficacy of an adjuvanted herpes zoster subunit vaccine in older adults - PubMed
The HZ/su vaccine significantly reduced the risk of herpes zoster in adults who were 50 years of age or older. Vaccine efficacy in adults who were 70 years of age or older was similar to that in the other two age groups. (Funded by GlaxoSmithKline Biologicals; ZOE-50 ClinicalTrials.gov number...
HPV vaccine efficacy
RFA temp influences time to repeat. small study but looks powered enoughImpact of temperature on the magnitude and duration of relief after lumbar facets medial branch nerves radiofrequency ablation: a randomized double-blinded study - PubMed
RFA has been demonstrated as an effective therapeutic modality for lumbar facetogenic back pain. Yet, the several factors involved in determining a favorable outcome of this procedure require further research and optimization. This prospective double-blinded randomized trial demonstrated that...
but i have to get back to work...
The other stuff is primary care treatments.
I asked what RCT in the pain world guides your treatments and avoids the criticisms level at the scrambler literature. Really simple question..
paying for a machine introduces bias.
the reason i posted primary care studies (sic Internal Medicine) is because that is what EBM was originally focused on, and these studies show the dearth and poor quality evidence we have for pain treatments.
to start, you can go and google the plethora of articles posted by Manchikanti regarding pain injections that CMS uses to "approve" injections. they are poor quality and biased but at minimum they are powered sufficiently, which none of your studies for scrambler remotely approaches.
the reason i posted primary care studies (sic Internal Medicine) is because that is what EBM was originally focused on, and these studies show the dearth and poor quality evidence we have for pain treatments.
to start, you can go and google the plethora of articles posted by Manchikanti regarding pain injections that CMS uses to "approve" injections. they are poor quality and biased but at minimum they are powered sufficiently, which none of your studies for scrambler remotely approaches.
As an EBM guy, are you advocating using poor quality biased studies that are powered to guide our treatments?
Or are you saying that we are all snake oil salesman and should accept that or go to IM.
BTW...while this discussion was going on, I saw another trigeminal neuralgia patient who had seen 4 pain docs (and had done everything you can imagine) and 2 neurosurgeons and still had 7-9/10 pain everyday. She left my office with a 2-3/10 for the first time in 20 years and has been there for at least 14 days. For the sake of brevity and time I am going to agree to disagree with you and go back to what I was doing. My point remains that evidence is helpful in guiding decisions but we see individual patients and we are tasked with helping them relieve their suffering . If you ever do answer my question, I would be interested in reading.
Thank you.
Or are you saying that we are all snake oil salesman and should accept that or go to IM.
BTW...while this discussion was going on, I saw another trigeminal neuralgia patient who had seen 4 pain docs (and had done everything you can imagine) and 2 neurosurgeons and still had 7-9/10 pain everyday. She left my office with a 2-3/10 for the first time in 20 years and has been there for at least 14 days. For the sake of brevity and time I am going to agree to disagree with you and go back to what I was doing. My point remains that evidence is helpful in guiding decisions but we see individual patients and we are tasked with helping them relieve their suffering . If you ever do answer my question, I would be interested in reading.
Thank you.
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then you fail to see, i daresay on purpose?
get more and better data. its out there.
in the meantime, offer treatments that have good and best available data to support use, while encouraging further study. dont rely on small biased studies - it is deceptive and preys on people who are desperate for a cure that is not there. ethics >profits.
fwiw, when i started, i took over a practice that had hundreds of patients who told me that their 7-9/10 pain was a 1.
or 0 when the patient was comatose after they took extra oxys or dilaudids.
your point?
get more and better data. its out there.
in the meantime, offer treatments that have good and best available data to support use, while encouraging further study. dont rely on small biased studies - it is deceptive and preys on people who are desperate for a cure that is not there. ethics >profits.
fwiw, when i started, i took over a practice that had hundreds of patients who told me that their 7-9/10 pain was a 1.
or 0 when the patient was comatose after they took extra oxys or dilaudids.
your point?
My point is you have not answered my question?
What pain literature is constructed well enough and meets your lofty standards to guide YOUR daily treatment of your personal patients? Please do tell.
You have previously said that our literature is biased and of poor quality. So what is one to do?
Accept that we are all snake oil salesman by your definition or leave the specialty or something else?
What did you do for them if you don’t mind posting? I see a ton of TN and love more options.
If meds aren't optimized (they usually are) and if they have failed cyberknife then scrambler plus or minus MLS laser. Have an N of about 35 from about 12 states that fall into this category and about 20-22 or so have done well which I define as 50 percent pain reduction for at least 6 months.
Shorter courses of treatment are effective if they come out of remission.
Risk of complications are as close to zero as you can get.
