New RCT showing lumbar facet corticosteroid injections are not therapeutic

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Dr. Bruce Banner

Dr. Bruce Banner

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Just curious what people think the paper that got published in anesthesiology last month about lumbar facet joint injection not being therapeutic?
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So the patients who get 3-4 months pain relief 3-4 times a year for years from facet injections are just incredible placebo responders? I definitely go to MBB/RF first, but I do some facet injections, including sometimes on patients who have failed RF, with usually good results
 
Effectiveness of Lumbar Facet Joint Blocks and Predictive Value before Radiofrequency Denervation:The Facet Treatment Study (FACTS), a Randomized, Controlled Clinical Trial | Anesthesiology | ASA Publications

Abstract
What We Already Know about This Topic:
  • Facet blocks, including intraarticular and medial branch blocks, are frequently used before radiofrequency ablation, but their validity as a predictive tool is unproven
  • Recently, the evidence supporting radiofrequency ablation has come under great scrutiny
What This Article Tells Us That Is New:
  • This randomized study establishes the lack of long-term efficacy for intraarticular and medial branch facet blocks but suggests the possibility that when used as prognostic tools, these injections may possibly provide superior outcomes before radiofrequency ablation on some measures compared to control blocks
Corticosteroid Injections into Lumbar Facet Joints: A Prospective, Randomized, Double-Blind... - Abstract - Europe PMC
Abstract
Corticosteroid injections into the intra-articular (IA) zygapophysial (z-joints) are frequently utilized to treat this cause of low back pain. No studies have been done on the efficacy of IA corticosteroids in those with z-joint pain confirmed by dual comparative medial branch blocks (MBB).To determine if an injection of a corticosteroid into lumbar z-joints is effective in reducing pain and the need for radiofrequency neurotomy (RFN).Double-Blind, prospective, randomized, placebo controlled trial SETTING: Academic Medical Center PATIENTS: 28 subjects with z-joint pain confirmed by MBBs.Subjects with confirmed z-joint pain via dual comparative MBB were randomized to receive either intra-articular corticosteroid (triamcinolone 20 mg) or saline via fluoroscopic guided injection.Need for RFN RESULTS: No statistically significant difference in the need for radiofrequency neurotomy (RFN) between the groups, with 75% [95% CI (50.5-99.5%)] of the saline group vs 91% [95% CI (62.3-100%)] of the corticosteroid group receiving RFN. No difference in mean time to RFN between saline (6.1 weeks) and corticosteroid (6.5 weeks) groups.Corticosteroid injections into the lumbar z-joints were not effective in reducing the need for RFN of the medial branches in those with z-joint pain confirmed by dual comparative MBBs.
 
Both these papers show no difference between MBNB and intra-articular injections for the majority of patients, in terms of time/need for an RFA.
That doesn't mean IA injections don't work.
That doesn't mean there aren't some folks who respond longer/better to IA than others, allowing you to push the time to RFA down the road.

My general algorithm is IA 1st followed by confirmatory MBNB if no durable relief, with aggressive PT work around the first injection. I don't think the lack of signal in small studies (n = 150 and 30 for the above) should overrule the rare responder patients we see in practice.
 
drrosenrosen said:
So the patients who get 3-4 months pain relief 3-4 times a year for years from facet injections are just incredible placebo responders? I definitely go to MBB/RF first, but I do some facet injections, including sometimes on patients who have failed RF, with usually good results
Click to expand...

Here's the conundrum for me: I have a handful of older, mostly Medicare patients who don't seem "to get" the MBB-->RF paradigm or don't get relief from the MBB's, but get consistent results from IA facets. I review the pain diary and it's GIGO. But, they do seem to get relief from IA facet injections. I don't think that this has been studied well. I think that there is a sub-set of IA facet responders. Someone should study the responders. Maybe they're co-morbid stenotics and they get some epidural overfill or something...but, when a retired air force Master Sergeant tells me the facet injections worked but the MBB's didn't work worth ****, I believe him...
 
I think there’s a role, albeit limited, for IA steroid from a practical standpoint...

-Young subacute whiplash patients

-patients who can’t grasp the concept of mbb/rf.... and just that there’s something more advanced if/when the cortisone doesn’t last.

-have a big vacation, wedding, etc coming up and need relief now. As mbb x2, rf then waiting for relief will be a few months

- patients who used to get a few months relief w IA, then fail RFA after mbbx2 (as we all know it’s not 100% successful)
 
Private insurance guidelines state that facet joint injections are diagnostic, not therapeutic. Some of them require RFA to be done after the first set of facet injections or a second set of facets then RFA. So you can do the facets, wait until pain returns and then do ablation. Is that how we were trained in fellowship? Nope. Does it get paid every single time? Yep.
 
lobelsteve said:
Your personal experiences are just bias, not science. Hard to listen to science with patients telling you otherwise.
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Yes, unless you can point to a study that shows clinically significantly benefit.

Now I can’t say that you can’t do the injection per se. you should make the patient aware that this is not best practice however, and should have some science to back you up.

It may have to be in the form of a Manchikanti study. For cervical Mbb:
Cost Utility Analysis of Cervical Therapeutic Medial Branch Blocks in Managing Chronic Neck Pain. - PubMed - NCBI

Or Comparison of Intraarticular Pulsed Radiofrequency and Intraarticular Corticosteroid Injection for Management of Cervical Facet Joint Pain. - PubMed - NCBI


Or this study a few years back for lumbar facets:

A comparison of intraarticular lumbar facet joint steroid injections and lumbar facet joint radiofrequency denervation in the treatment of low back p... - PubMed - NCBI

(edit’d for auto correct, sorry)
 
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VA Hopeful Dr said:
Yes because medical science has never been wrong before.

Or the studies weren't designed well.
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We mock what we dont understand.

See you at SIS. EBM level 2 class. Im studying hard and will still be embarrassed by my limited medical statistics knowledge base.
 
lobelsteve said:
We mock what we dont understand.

See you at SIS. EBM level 2 class. Im studying hard and will still be embarrassed by my limited medical statistics knowledge base.
Click to expand...
I don't claim to be great at any of that. But in the 8 short years I've been a physician, I've seen numerous studies get retracted or proven wrong when follow up studies were done. That doesn't even get into the issues with the actual statistics used (which is mostly beyond me truthfully, but you see articles that poke holes in some of the ways we analyze data that are concerning).

My only point is that absolute devotion to EBM is not always wise.
 
There were something like 1.5 million facet interventions billed to CMS in 2006. Defining guidelines or changing practice parameters based off of small studies of under 100 - 200 patients is not ideal but that's what we've got to run with.

These studies are not powered to capture rare events and the 0.0001% of patients studied may not be representative of your patient population.
 
VA Hopeful Dr said:
I don't claim to be great at any of that. But in the 8 short years I've been a physician, I've seen numerous studies get retracted or proven wrong when follow up studies were done. That doesn't even get into the issues with the actual statistics used (which is mostly beyond me truthfully, but you see articles that poke holes in some of the ways we analyze data that are concerning).

My only point is that absolute devotion to EBM is not always wise.
Click to expand...
You can always debate and do more studies to clarify EBM. You can’t do the same against dogma.


FWIW, good studies are evaluated prior to the actual study and powered so that sample size is sufficiently strong enough to support conclusions for a much larger population. You do have to read deep in to the study.

Retrospective studies and case reports & cohort studies do not carry this level of depth typically.
 
Ducttape said:
You can always debate and do more studies to clarify EBM. You can’t do the same against dogma.


FWIW, good studies are evaluated prior to the actual study and powered so that sample size is sufficiently strong enough to support conclusions for a much larger population. You do have to read deep in to the study.

Retrospective studies and case reports & cohort studies do not carry this level of depth typically.
Click to expand...
And that's part of what I'm thinking about. Consider about how often we are told to stop doing something or start doing something as the result of a usually poorly designed meta-analysis.

I'm not saying don't do EBM (obviously), just be mindful of it's limitations.
 
There's a lot of paltering that goes on in the EBM world
 
so, in that case, what is the holy grail?

is it the gospel according to drusso, or is it the manifesto of lobelsteve?


fwiw, the articles more focus on RCTs on economics, and they do not posit an alternative method of study.

this article does: Alternatives to the Randomized Controlled Trial
[QUOTE
CONCLUSION
The RCT is the gold standard among research designs. It has the highest internal validity because it requires the fewest assumptions to attain unbiased estimates of treatment effects. Given identical sample sizes, the RCT also typically surpasses all other designs in terms of its statistical power to detect the predicted effect. Nonetheless, even with the best planning, the RCT is not immune to problems common in community trials. These threats potentially weaken the causal inferences.

When RCTs cannot be implemented in settings or with participants of interest, it is far better to use a strong alternative design than to change the treatment (e.g., using an analog rather than an actual faith-based treatment) or study population (e.g., using only participants indifferent to the treatment choice) so that an RCT may be implemented. Such changes may severely limit the external validity of the findings, potentially distorting the inference about the causal effect for the specific population, treatment, and setting of interest. Even when RCTs can be implemented, alternative designs can be valuable complements that broaden the generalizations of RCTs in multi-study programs of research.
][/QUOTE]
 
Ducttape said:
so, in that case, what is the holy grail?

is it the gospel according to drusso, or is it the manifesto of lobelsteve?


fwiw, the articles more focus on RCTs on economics, and they do not posit an alternative method of study.

this article does: Alternatives to the Randomized Controlled Trial
[QUOTE
CONCLUSION
The RCT is the gold standard among research designs. It has the highest internal validity because it requires the fewest assumptions to attain unbiased estimates of treatment effects. Given identical sample sizes, the RCT also typically surpasses all other designs in terms of its statistical power to detect the predicted effect. Nonetheless, even with the best planning, the RCT is not immune to problems common in community trials. These threats potentially weaken the causal inferences.

When RCTs cannot be implemented in settings or with participants of interest, it is far better to use a strong alternative design than to change the treatment (e.g., using an analog rather than an actual faith-based treatment) or study population (e.g., using only participants indifferent to the treatment choice) so that an RCT may be implemented. Such changes may severely limit the external validity of the findings, potentially distorting the inference about the causal effect for the specific population, treatment, and setting of interest. Even when RCTs can be implemented, alternative designs can be valuable complements that broaden the generalizations of RCTs in multi-study programs of research.
]
Click to expand...
[/QUOTE]

After you're sent away to the re-education camp, it will always be the Gospel first followed by mandatory recitals from the Manifesto...

RCT's are wonderful, and the only way to experimentally manipulate variables to deduce true and effect but often don't answer questions clinicians want to know due to practical or ethical considerations. I'm a fan of the within-subject (N=1) repeated measures design...

Far better an approximate answer to the right question, which is often vague, than an exact answer to the wrong question, which can always be made precise. —John Tukey
 
The agenda is to discredit the most commonly performed pain procedures so medicare and insurers don't need to pay for them. Epidurals first, facet injections now, and it will progress until every procedure is "disproven" to be effective, until there is almost nothing to pay for. As always, follow the money.

I almost never perform intra-articular facet steroid injections so have very little in this fight, but it still bothers me.
 
I can’t help but notice the irony of how up in arms you all seem to be over an RCT that disagrees with your point of view on facet injections; but when an RCT agrees with your opinion on opioids not being helpful long term, most of you cheer it as definitive proof. Cognitive dissonance right?
 
on the contrary, some of us do not agree that opioids are helpful long term at all.

there aren't any RCTs that have shown that opioids are helpful for chronic nonmalignant pain, unlike prior studies on facet joint injections.
 
Ligament said:
The agenda is to discredit the most commonly performed pain procedures so medicare and insurers don't need to pay for them. Epidurals first, facet injections now, and it will progress until every procedure is "disproven" to be effective, until there is almost nothing to pay for. As always, follow the money.

I almost never perform intra-articular facet steroid injections so have very little in this fight, but it still bothers me.
Click to expand...

I agree 100% with this.
 
Ducttape said:
there aren't any RCTs that have shown that opioids are helpful for chronic nonmalignant pain
Click to expand...
:poke:

Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects
This is an older meta-analysis of 41 randomized trials involving 6019 patients for chronic non cancer pain showing opioids are better than placebo for pain/function, while opioids are inferior to other active agents for function, but maybe better for pain.

I think the full statement is that opioids are not worth the risk for chronic nonmalignant pain.

The point though is true in that we all have innate biases for/against things and no one likes to look for contrary POVs

Opioids are currently the devil.
Injections and implants are next.
Once the money is in psychology or physical therapy, that'll be found useless too I'm sure.
 
drusso said:
Here's the conundrum for me: I have a handful of older, mostly Medicare patients who don't seem "to get" the MBB-->RF paradigm or don't get relief from the MBB's, but get consistent results from IA facets. I review the pain diary and it's GIGO. But, they do seem to get relief from IA facet injections. I don't think that this has been studied well. I think that there is a sub-set of IA facet responders. Someone should study the responders. Maybe they're co-morbid stenotics and they get some epidural overfill or something...but, when a retired air force Master Sergeant tells me the facet injections worked but the MBB's didn't work worth ****, I believe him...
Click to expand...

So what's your algorithm? MBBs first, and if negative, and clear facet OA on imaging, then intra-articular facet injections (Local + steroid)?
 
Ligament said:
The agenda is to discredit the most commonly performed pain procedures so medicare and insurers don't need to pay for them. Epidurals first, facet injections now, and it will progress until every procedure is "disproven" to be effective, until there is almost nothing to pay for. As always, follow the money.

I almost never perform intra-articular facet steroid injections so have very little in this fight, but it still bothers me.
Click to expand...

Agree.

For anyone who doubts this, and has some experience in doing worker's comp,

Take a look at the ACOEM Guidelines.

In my area, there was a regulatory fight over whether to adopt ACOEM vs. ODG. You can guess which Guidelines those paying the bills wanted.
 
Orin said:
:poke:

Opioids for chronic noncancer pain: a meta-analysis of effectiveness and side effects
This is an older meta-analysis of 41 randomized trials involving 6019 patients for chronic non cancer pain showing opioids are better than placebo for pain/function, while opioids are inferior to other active agents for function, but maybe better for pain.

I think the full statement is that opioids are not worth the risk for chronic nonmalignant pain.

The point though is true in that we all have innate biases for/against things and no one likes to look for contrary POVs

Opioids are currently the devil.
Injections and implants are next.
Once the money is in psychology or physical therapy, that'll be found useless too I'm sure.
Click to expand...
Meta-analysis is a junk study and is probably more subject to bias than anything else. One “looks” for the effect of choice. In this “study”, there were essentially 2 reviewers...

Please note:
1. pain assessment was not specified, and may have been done via non reproducible scores such as VAS
2. Only 17 of the 41 studies used had stringent enough criteria “to be judged random”.
3. 90% of the studies were sponsored by or had a coauthor affiliated with pharma.
4. The average duration of these trials was only 5 weeks. This does not qualify as long term use of opioids.
5. Patients with previous addiction were screened out of 25 of the 41 trials, and not specified in the other 16, which may have confounded those results
6. Out of 41 trials used, only ONE of them asked patients direct questions about addiction symptoms (2 used indirect questions, whatever that means...)
7. And in that one study, 8.7% of morphine patients (vs 4.3% of placebo) developed drug craving. A lot higher than 0.6%, if you ask me...
 
I do IA facets instead of MBB in the following cases:

1. Anticoagulant use and a good reason the patient can't/shouldn't stop it repeatedly.
2. Sick or frail patients I want to do as little as possible to
3. Slower people who just can't get the whole MBB/RFA thing
4. People with big schedule or financial issues. Could be limited time off work, big event coming up, going out of town, insurance ends next month, end of the year and deductible resets Jan 1st, etc.
5. Young healthy people who I want to poke as little as possible

Just throwing in my 2 cents...
 
Ferrismonk said:
I do IA facets instead of MBB in the following cases:

1. Anticoagulant use and a good reason the patient can't/shouldn't stop it repeatedly.
2. Sick or frail patients I want to do as little as possible to
3. Slower people who just can't get the whole MBB/RFA thing
4. People with big schedule or financial issues. Could be limited time off work, big event coming up, going out of town, insurance ends next month, end of the year and deductible resets Jan 1st, etc.
5. Young healthy people who I want to poke as little as possible

Just throwing in my 2 cents...
Click to expand...
These are all the same reasons I would do facet injection instead of mbb/rf. I, however, don't hold anticoagulants for MBB/RF, so that one doesn't apply to me.
 
drrosenrosen said:
These are all the same reasons I would do facet injection instead of mbb/rf. I, however, don't hold anticoagulants for MBB/RF, so that one doesn't apply to me.
Click to expand...

I've been changing slowly on this. This year's guidelines are more liberal with continuing anticoagulation than I'm used to. Maybe I've just been involved with too many anesthesia cases where plavix is the enemy of everything.
 
As is being discussed on the private board, it's really just a matter of balancing risk and benefit. The odds of a dangerous hematoma from an extraspinal procedure like lumbar, or even cervical, RF, are lower than the odds of thromboembolic event after discontinuing anticoagulants.
 
Ferrismonk said:
I do IA facets instead of MBB in the following cases:

1. Anticoagulant use and a good reason the patient can't/shouldn't stop it repeatedly.
2. Sick or frail patients I want to do as little as possible to
3. Slower people who just can't get the whole MBB/RFA thing
4. People with big schedule or financial issues. Could be limited time off work, big event coming up, going out of town, insurance ends next month, end of the year and deductible resets Jan 1st, etc.
5. Young healthy people who I want to poke as little as possible

Just throwing in my 2 cents...
Click to expand...


IA 1st under age 35, rfa if doesn't last
 
drrosenrosen said:
These are all the same reasons I would do facet injection instead of mbb/rf. I, however, don't hold anticoagulants for MBB/RF, so that one doesn't apply to me.
Click to expand...

In our practice, we continue anticoagulation for MBN, but hold for the cRFA
 
Ducttape said:
there aren't any RCTs that have shown that opioids are helpful for chronic nonmalignant pain, unlike prior studies on facet joint injections.
Click to expand...

Oxymorphone Extended-Release Tablets (Opana ER) For the Management of Chronic Pain: A Practical Review for Pharmacists

upload_2018-8-24_22-52-51.jpeg
 
These are not RCTs, this is a Cochrane review. No long term study was done. Even so, the conclusions are damning against opioids. (Intermediate studies were only to 12 weeks - the equivalent of 3 month prescriptions...)

AUTHORS' CONCLUSIONS: Since the last version of this review, new studies were found providing additional information. Data were reanalyzed but the results did not alter any of our previously published conclusions. Short-term studies provide only equivocal evidence regarding the efficacy of opioids in reducing the intensity of neuropathic pain. Intermediate-term studies demonstrated significant efficacy of opioids over placebo, but these results are likely to be subject to significant bias because of small size, short duration, and potentially inadequate handling of dropouts. Analgesic efficacy of opioids in chronic neuropathic pain is subject to considerable uncertainty. Reported adverse events of opioids were common but not life-threatening. Further randomized controlled trials are needed to establish unbiased estimates of long-term efficacy, safety (including addiction potential), and effects on quality of life.
Click to expand...


And your first article is a glorified position paper.


Move on.
 
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