So Does Vertebroplasty Work Or Not?

[Blitz2006]

Just read a recent study that came out in BMJ that showed no statistical difference between Vertebroplasty and Sham:

Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial

In the past decade, there are now 2 large RCTs that are yay for Vertebroplasty, and now 3 that are nay...

Your thoughts?

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[willabeast]

My anecdotal clinical impression is that an IL ESI done one level below works as well or better.

 

[lobelsteve]

Prelim review reveals 1280 looked at and only 180 enrolled.
VAS set too low at 5/10 as inclusion criteria. Would not consider unless 7/10 as reasonable inclusion criteria.
More to follow.

 

[drpainfree]

My anecdotal clinical impression is that an IL ESI done one level below works as well or better.

any literature evidence ILESI improve compression fracture pain?

 

[Blitz2006]

Prelim review reveals 1280 looked at and only 180 enrolled.
VAS set too low at 5/10 as inclusion criteria. Would not consider unless 7/10 as reasonable inclusion criteria.
More to follow.

Agreed. And in fairness, the authors mention this:

" VAPOUR included predominantly hospital inpatients (56-58%) with pain for less than six weeks (mean 2.4-2.8 weeks), high VAS scores (>7) at baseline necessitating opiate analgesics in 90% of participants, and a sham procedure without infiltration of the pedicle"

 

[geauxg8rs]

So half of the group got a plasty and the other half got a local lidocaine and deep bupivicaine injection? And then you measure pain at one month? Of course the “sham” group had a pain reduction because there was no sham group! There should have been a true non treatment arm which did not get an injection of local which can be effective for relieving pain at a four week mark. How many patients got better because their fracture pain is healing/healed vs how many got relief or placebo effect from the local injections? We don’t know, there needed to be a non treatment arm.

I was only able to see the abstract but the pain scores are comparing pain at one month and twelve months? Who picked these time points? Obviously both groups should be better at 12 months since the fractured is long healed.
In my mind a vertebroplasty is beneficial in achieving quicker pain relief than not doing anything. Sure we can dope elderly patients up for several months while their fracture heals or they can get more immediate relief with a clearer mind. The pain relief at 1, 2,3,4 months is of clinical use. 12 months is useless.

I think there is a lot of bias in this study.

 

[NJPAIN]

My anecdotal clinical impression is that an IL ESI done one level below works as well or better.

I have not observed the same. Are others finding ILESI helpful? Is there any literature to support it’s use? If so, perhaps I need to reconsider trying it again especially given that the hospital is giving me the runaround about doing Kyphoplasty


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[lobelsteve]

I have not observed the same. Are others finding ILESI helpful? Is there any literature to support it’s use? If so, perhaps I need to reconsider trying it again especially given that the hospital is giving me the runaround about doing Kyphoplasty


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Do them in your office. Local only, can give 1mg Ativan #2 if they have a driver.

 

[drusso]

Do them in your office. Local only, can give 1mg Ativan #2 if they have a driver.

Read Vinay Prasad's Book "Ending Medical Reversal." He's spends considerable time analyzing vert augmentation, concludes that it is theatrical placebo, and advocates publicly that legitimate science-based practitioners abandon it's use. He's a colleague of Roger Chou's at OHSU:

Vinay Prasad (@VinayPrasadMD) | Twitter

Amazon product

 

[Ducttape]

So half of the group got a plasty and the other half got a local lidocaine and deep bupivicaine injection? And then you measure pain at one month? Of course the “sham” group had a pain reduction because there was no sham group! There should have been a true non treatment arm which did not get an injection of local which can be effective for relieving pain at a four week mark. How many patients got better because their fracture pain is healing/healed vs how many got relief or placebo effect from the local injections? We don’t know, there needed to be a non treatment arm.

I was only able to see the abstract but the pain scores are comparing pain at one month and twelve months? Who picked these time points? Obviously both groups should be better at 12 months since the fractured is long healed.
In my mind a vertebroplasty is beneficial in achieving quicker pain relief than not doing anything. Sure we can dope elderly patients up for several months while their fracture heals or they can get more immediate relief with a clearer mind. The pain relief at 1, 2,3,4 months is of clinical use. 12 months is useless.

I think there is a lot of bias in this study.

- actually that is wrong. a sham procedure eliminates a lot of bias.

clearly the best study would have 3 arms, but that is difficult in and of itself because those in the conservative arm would know they did not get the procedure for sure.

- if you want to determine long term benefits from a procedure, something longer than 3 months is indicated. because 3 months or less may still be due to local or steroid (if used) effect. however... the abstract said that comparisons were made a 1 day, 1 week, 1 months, 3, 6 and 12 months. so it wasnt just 1 month and 12 months.

- im not sure steve's points about having 1280 patients screened and taking only 160 patients. these are screening criteria and randomization occurred afterwards. should not affect the study results.

- not sure the study is completely applicable to the US. this study was done in Netherlands, where i suspect they anticipate some modicum of chronic pain and may not have the same expectations of opioid prescribing and complete pain relief that we in the US expect...

 

[Orin]

Interesting study.

The relatively active sham placebo is hard and adds a good bit of risk/cost.

The study does show benefit/efficacy for both treatments for pain, and if you assume the sham is minimally active, then it's reasonable. I suppose we could all just start doing pedicle infiltration for these and let folks smell the cement. The bupi and periosteal needle placement could possibly help long term for pain. Aromatherapy has evidence for analgesia, although this is the first study showing the benefit of sniffing PMMA.

The vertebroplasty does appear to significantly reduce chronic pain associated to VCFs, lead to reduced height loss, and for patients with severe pain or high opioid usage there appears to be a more marked effect.

As the authors say though, these results are primarily for vertebroplasty without instrumentation or cavity creation and aren't necessarily applicable to those other procedures.

Overall though, I'm getting that cementing is relatively safe, may not be necessary for mild-moderate pain, and isn't associated with creation of new fractures.

 

[geauxg8rs]

- actually that is wrong. a sham procedure eliminates a lot of bias.

clearly the best study would have 3 arms, but that is difficult in and of itself because those in the conservative arm would know they did not get the procedure for sure.

- if you want to determine long term benefits from a procedure, something longer than 3 months is indicated. because 3 months or less may still be due to local or steroid (if used) effect. however... the abstract said that comparisons were made a 1 day, 1 week, 1 months, 3, 6 and 12 months. so it wasnt just 1 month and 12 months.

- im not sure steve's points about having 1280 patients screened and taking only 160 patients. these are screening criteria and randomization occurred afterwards. should not affect the study results.

- not sure the study is completely applicable to the US. this study was done in Netherlands, where i suspect they anticipate some modicum of chronic pain and may not have the same expectations of opioid prescribing and complete pain relief that we in the US expect...

My point is that there was no sham arm. Both arms are treatments. There needed
To be a no injection of anything arm.

Steve’s point is valid. Having that many people eliminated or choosing not to participate does show selection bias

 

[powermd]

Dumb study. In a series of dumb studies. So dumb, in fact, I don't think it's dumb at all. I think it's intentionally biased.

As others have said, the sham arm is a treatment arm.

I would submit that patients experiencing pain in association with a vertebral compression fracture may be suffering from one or more of the following: fracture pain, facet pain, myofascial pain.

How many of you have treated a fracture, had no improvement, or partial improvement, and then went on to treat the facet joints around the fracture leading to resolution of the pain? I have had many such cases.

Could a wedge fracture change the loading of the facet joints such that the patient now has facet syndrome? Sure, why not?

So the facet joints adjacent to the fracture level are a potential pain generator in patients with vertebral compression fractures. This needs to be accounted for in the study design.

What happened to the patients in the study who had persistent pain after vertebroplasty? Was there any further evaluation to see if they might have facet or myofascial pain? Or were they just shown the door?

Second major point: Recruitment. As Steve said, too low a threshold VAS, and the 12 month commitment with no possibility of crossover probably scared away the patients most likely to benefit from fracture treatment.

What this study needs is double crossover, and a true control with no stupid sham. If you fail vertebroplaty, you get MBBs/RF. If you fail MBBs/RF, you get vertebroplasty.

 

[emd123]

I don't know how the hell these people are finding "no benefit" in any vertebral augmentation study. I do kypho in office and it's one of the most successful things I do. I swear to God, it's got to be around 90% success rate, in pain reduction. And it's not a little bit of pain relief. I'm seeing approx 80-90% (give or take) having at least 80-90% pain relief at one week follow ups and it's holding over time, too. I don't know if there selection is sh**y, if they're backed by some interests that want to kill kyphoplasty and vertebroplasty for some reason or what's going on. But every time is see one of these studies, I'm more and more convinced something is rotten in the state of Denmark, because kypho works. There's a lot of things we do, where the efficacy is very, very suboptimal. But kyphoplsty, in patients with unhealed painful compression fractures with edema on STIR MRI images, is not one of them.

 

[powermd]

I don't know how the hell these people are finding "no benefit" in any vertebral augmentation study. I do kypho in office and it's one of the most successful things I do. I swear to God, it's got to be around 90% success rate, in pain reduction. And it's not a little bit of pain relief. I'm seeing approx 80-90% (give or take) having at least 80-90% pain relief at one week follow ups and it's holding over time, too. I don't know if there selection is sh**y, if they're backed by some interests that want to kill kyphoplasty and vertebroplasty for some reason or what's going on. But something is rotten in the state of Denmark, because kypho works. There's a lot of things we do, where the efficacy is very, very suboptimal. But kyphoplsty, in patients with unhealed painful compression fractures with edema on STIR MRI images, is not one of them.

Easy.

Pick patients with pain, but don't be particular about how much.

Make sure your study design frightens away those with the greatest need.

Add a sham that treats a problem people with compression fractures are likely to have, and in some cases - particularly the weaker ones that volunteered for your study - may in fact be their true pain generator.

Voila- you have a study result that flies in the face of anyone actually practicing medicine.

 

[emd123]

Easy.

Pick patients with pain, but don't be particular about how much.

Make sure your study design frightens away those with the greatest need.

Add a sham that treats a problem people with compression fractures are likely to have, and in some cases - particularly the weaker ones that volunteered for your study - may in fact be their true pain generator.

Voila- you have a study result that flies in the face of anyone actually practicing medicine.

So what's the motivator then?
Who are the shady actors pushing these crap studies and what's their secondary gain? I don't buy that it's just out of pure sloppiness, although I suppose it could be.

 

[emd123]

Do them in your office. Local only, can give 1mg Ativan #2 if they have a driver.

Yeah, why aren't you doing your kypho's in-office, @NJPAIN ?

 

[NJPAIN]

Yeah, why aren't you doing your kypho's in-office, @NJPAIN ?

Very simple. No fluoro currently. I’m taking a big hit working out of a facility still. Yes, hard to believe. The regulations in this state are my biggest obstacle as a solo guy. Looking at my office in a neighboring state as a more viable site. Then I may need to coax SLOBEL into inviting me down to learn how the master does it under straight local.




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[powermd]

So what's the motivator then?
Who are the shady actors pushing these crap studies and what's their secondary gain? I don't buy that it's just out of pure sloppiness, although I suppose it could be.

Almost all the guys doing the study are radiologists. Does that tell you anything?

These probably have no concept of how to comprehensively evaluate a patient in pain.

Is this the same crew that managed to screw up a study on medial branch RF?

 

[Blitz2006]

I don't know how the hell these people are finding "no benefit" in any vertebral augmentation study. I do kypho in office and it's one of the most successful things I do. I swear to God, it's got to be around 90% success rate, in pain reduction. And it's not a little bit of pain relief. I'm seeing approx 80-90% (give or take) having at least 80-90% pain relief at one week follow ups and it's holding over time, too. I don't know if there selection is sh**y, if they're backed by some interests that want to kill kyphoplasty and vertebroplasty for some reason or what's going on. But every time is see one of these studies, I'm more and more convinced something is rotten in the state of Denmark, because kypho works. There's a lot of things we do, where the efficacy is very, very suboptimal. But kyphoplsty, in patients with unhealed painful compression fractures with edema on STIR MRI images, is not one of them.

What's your cutoff before you decide it's not worth doing kypho?

2 months? 3 months since fracture?

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[Blitz2006]

I agree with others that cross over should have been done. Question is, when?

3 months?

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[lobelsteve]

Very simple. No fluoro currently. I’m taking a big hit working out of a facility still. Yes, hard to believe. The regulations in this state are my biggest obstacle as a solo guy. Looking at my office in a neighboring state as a more viable site. Then I may need to coax SLOBEL into inviting me down to learn how the master does it under straight local.




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Happy to have you.

 

[lobelsteve]

What's your cutoff before you decide it's not worth doing kypho?

2 months? 3 months since fracture?

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Cutoff is lack of stir intensity on mri.

 

[Ducttape]

so you guys are all showing your own bias towards benefits. It is judicious to be neutral, or at least have an open mind....

the sham arm is an active arm, and you may belittle the presence of the sham, but it is the only way of accounting for the fact that patients will feel placebo effect with any injection. One can also argue that a simple local block can be helpful.

Also, it can be effectively argued that the lack of a sham injection would be a major reason to question a kypho vs. no procedure arm.

second, "it's one of the most successful things I do" is also probably heard in every office that has a provider that does PRP, uses stem cell treatment, sticks acupuncture, has a cathoholic physician, or infuses ketamine. you need scientific proof. This article does not completely disprove that veryebroplasty doesn’t work... just that it is not much better than a local block. And maybe the success from the vertebroplasty in the office is due to the local.....

 

[powermd]

Duct,

Why does the sham need to be a facet injection with anesthetic, of all things?

How about just a needle placement and withdrawal?

If you're going to call it a placebo, there should be no possibility of a therapeutic effect.

I'm sure we've all seen patients with symptoms of facet syndrome who have an unusually long period of anesthetic relief. I can't easily explain that, but it's a thing. Eventually the pain returns and we finish the job.

so you guys are all showing your own bias towards benefits. It is judicious to be neutral, or at least have an open mind....

the sham arm is an active arm, and you may belittle the presence of the sham, but it is the only way of accounting for the fact that patients will feel placebo effect with any injection. One can also argue that a simple local block can be helpful.

Also, it can be effectively argued that the lack of a sham injection would be a major reason to question a kypho vs. no procedure arm.

second, "it's one of the most successful things I do" is also probably heard in every office that has a provider that does PRP, uses stem cell treatment, sticks acupuncture, has a cathoholic physician, or infuses ketamine. you need scientific proof. This article does not completely disprove that veryebroplasty doesn’t work... just that it is not much better than a local block. And maybe the success from the vertebroplasty in the office is due to the local.....

 

[lobelsteve]

A sham would be performing the procedure in both arms identically. But leave out the hardener in one group and have the doc and patient blinded. Not sure I would consent for that experiment.

 

[BobBarker]

But then there is the “trocar mediated rhizotomy of the medial branch nerves” in both groups.

 

[Ducttape]

Access into the collapsed vertebrae may cause pain.

You can argue for saline. That is a valid concern, ie the use of local, and a valid criticism of the study.

 

[Orin]

Based on these data though, you should do something at 30-45 days if they're still hurting and STIR positive, even if it is a sham procedure.

I would be intrigued to see how many cases do great with just pedicle infiltration/blocks instead of cementing. It might be something to offer patients that can't come off of anticoagulation or are not candidates for an intervention for some other reason.

 

[drusso]

 

[drpainfree]

Based on these data though, you should do something at 30-45 days if they're still hurting and STIR positive, even if it is a sham procedure.

I would be intrigued to see how many cases do great with just pedicle infiltration/blocks instead of cementing. It might be something to offer patients that can't come off of anticoagulation or are not candidates for an intervention for some other reason.

what's "pedicle infiltration/block"? how do you bill for these?

 

[Orin]

I would have to say you'd bill it as a MBNB if you were actually doing this, because that is what you'd be doing.

Now that I google this, it seems that this has more support for it than I had thought, but I suppose it is similar to TFESIs. If the benefit is the same, then do the thing which makes more money?

The pain of vertebral compression fractures can arise in the posterior elements. - PubMed - NCBI

I suspect the study authors did not read this prior to designing their sham, in which case perhaps perhaps IM injections would have been more reasonable as a sham?

 

[drpainfree]

anyone has experience treating post-compression-fx pain with MNBB? what's your success rate?

 

[Jcm800]

I have not observed the same. Are others finding ILESI helpful? Is there any literature to support it’s use? If so, perhaps I need to reconsider trying it again especially given that the hospital is giving me the runaround about doing Kyphoplasty

I will say since I started doing an injection, either for sets or an epidural prior to Kyphoplasty, I do considerably less kyphoplasty. Reality is, since I started in bracing everyone and giving everyone six weeks of conservative treatment either just the brace, the brace and pain medication, the brace pain medication and an injection, facet or epidural, I do a whole lot less Kyphoplastyird. Like 75% less
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[PainandGain]

anyone has experience treating post-compression-fx pain with MNBB? what's your success rate?

I offer this to patients who present with pain in the area of chronic compression fractures. It's successful better than half the time. I RF when successful.

 

[PainandGain]

I don't know how the hell these people are finding "no benefit" in any vertebral augmentation study. I do kypho in office and it's one of the most successful things I do. I swear to God, it's got to be around 90% success rate, in pain reduction. And it's not a little bit of pain relief. I'm seeing approx 80-90% (give or take) having at least 80-90% pain relief at one week follow ups and it's holding over time, too. I don't know if there selection is sh**y, if they're backed by some interests that want to kill kyphoplasty and vertebroplasty for some reason or what's going on. But every time is see one of these studies, I'm more and more convinced something is rotten in the state of Denmark, because kypho works. There's a lot of things we do, where the efficacy is very, very suboptimal. But kyphoplsty, in patients with unhealed painful compression fractures with edema on STIR MRI images, is not one of them.

I agree. I love doing kyphos. I do a follow up at one week and 90% of patients are hugging me and thanking me because they have no pain when they couldn't walk prior. I don't get it.

 

[powermd]

anyone has experience treating post-compression-fx pain with MNBB? what's your success rate?

My algorithm is based on percussion tenderness.

Percussion tenderness + edema on STIR = kypho first, then MBBs/RF if still pain

No percussion tenderness +/- edema on STIR = MBBs/RF first, then kypho if still pain