New Jama article discounting rf

[Nonphysiologic]

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Radiofrequency Denervation on Pain Intensity in Patients With Low Back Pain

Manchikanti save us please by coming out with a study that shows otherwise [emoji120][emoji120]


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[lobelsteve]

Radiofrequency Denervation on Pain Intensity in Patients With Low Back Pain

Manchikanti save us please by coming out with a study that shows otherwise [emoji120][emoji120]


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If you bother to read the study he would realize that they were studying nonsense. They weren't testing medial branches via double diagnostic Paradigm. They're performing radiofrequency ablation on anyone red back pain and comparing that to exercise. Gigo.

 

[pmrmd]

It's breathtaking that JAMA would publish such a comically ******ed study. Too many confounders and inconsistencies to list. Who is the editor that approved it for print?

 

[bedrock]

It's breathtaking that JAMA would publish such a comically ******ed study. Too many confounders and inconsistencies to list. Who is the editor that approved it for print?

We should get all the pain societies to issue a refutation of the article.

 

[EtherBunny]

Radiofrequency Denervation on Pain Intensity in Patients With Low Back Pain

Manchikanti save us please by coming out with a study that shows otherwise [emoji120][emoji120]


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This is what worries me about interventional pain--the lack of high quality evidence to support some of the things that are routinely done. The fact that the Cochrane group did a systematic analysis in 2015 on RF for chronic low back pain and arrived at a non-reassuring conclusion is worrisome.

Citation:

Maas ET, Ostelo RWJG, Niemisto L, Jousimaa J, Hurri H, Malmivaara A, van Tulder MW. Radiofrequency denervation for chronic low back pain. Cochrane Database of Systematic Reviews 2015, Issue 10. Art. No.: CD008572. DOI: 10.1002/14651858.CD008572.pub2

Conclusion from Cochrane review:

"No high-quality evidence shows that radiofrequency denervation provides pain relief for patients with chronic low back pain. Similarly, no convincing evidence suggests that this treatment improves function. Moderate-quality evidence suggests that radiofrequency denervation might better relieve facet joint pain and improve function over the short term when compared with placebo. Evidence of very low to low quality shows that radiofrequency denervation might relieve facet joint pain as well as steroid injections. For patients with disc pain, only small long-term effects on pain relief and improved function are shown. For patients with SI joint pain, radiofrequency denervation had no effect over the short term and a smaller effect (based on one study) one to six months after treatment when compared with placebo. For low back pain suspected to arise from other sources, the results were inconclusive. Radiofrequency denervation is an invasive procedure that can cause a variety of complications."

 

[Dr. Ice]

Unless we come up with a way to treat back pain that is non disc non facet mediated the evidence for treating chronic low back pain will always suggest that nothing works. Not everyone with low back pain falls into these two categories yet as interventionalists this makes up the lion share of diagnoses to justify our treatment. Chronic myofasical pain exists but it doesn't get better with anything we do. That's the reality and it's a bitter pill to swallow for us and patients. So much of the what we end up doing is counseling of non catastrophizing behavior and liefestyle modification but let's face it that **** don't pay the bills...

 

[Nonphysiologic]

I have a lot of issues w the study but jama published it and insurances will point to it


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[bedrock]

Unless we come up with a way to treat back pain that is non disc non facet mediated the evidence for treating chronic low back pain will always suggest that nothing works. Not everyone with low back pain falls into these two categories yet as interventionalists this makes up the lion share of diagnoses to justify our treatment. Chronic myofasical pain exists but it doesn't get better with anything we do. That's the reality and it's a bitter pill to swallow for us and patients. So much of the what we end up doing is counseling of non catastrophizing behavior and liefestyle modification but let's face it that **** don't pay the bills...

Virtually all significant sources of non cancer axial low back pain fall into one of those two categories.
RFA for facet pain, and Nevro for disc pain (if they fail conservative treatments)

Chronic myofascial pain isn't that bad and never requires opioids. I'm not going to hold their hand for 20 minutes if they won't accept my expert medical opinion.

 

[lobelsteve]

Virtually all significant sources of non cancer axial low back pain fall into one of those two categories.
RFA for facet pain, and Nevro for disc pain (if they fail conservative treatments)

Chronic myofascial pain isn't that bad and never requires opioids. I'm not going to hold their hand for 20 minutes if they won't accept my expert medical opinion.

Congrats on getting that vp of medical affairs gig with Nevro.

 

[bedrock]

Congrats on getting that vp of medical affairs gig with Nevro.

Lol. Not putting Nevro in everybody, but it's been great to see a lot of patients with persistent significant discogenic axial low back pain improve this past year with Nevro. It's not perfect, but nice to finally have a decent option to offer patients and prevent needless lumbar fusions.

 

[Dr. Ice]

Lol. Not putting Nevro in everybody, but it's been great to see a lot of patients with persistent significant discogenic axial low back pain improve this past year with Nevro. It's not perfect, but nice to finally have a decent option to offer patients and prevent needless lumbar fusions.

Nice. Not sure how much I buy it but I'll take your word for it if you'd had that much success. Nevro's stock was certainly not hurting for awhile at least from what I've seen so someone(s) must like it. I guess maybe a lot of it is demographics. I see a good amount of patients who have non cancer axial low back pain who do not respond to conventional treatment for disc/facet and are not drug seekers. Are many of them at least somewhat overweight..yes. Do many of them need to change horrible dietary and lifestyle habits..yes. But there is certainly a subset of non chubsters non smokers who seem genuinely frustrated with ongoing symptoms despite treatment and I am reluctant to "sell" them on nevro but I suppose it's worth revisiting. I don't know if I would want a device in my spine for low back pain but I'm also not in their shoes..

 

[myrandom2003]

...I see a good amount of patients who have non cancer axial low back pain who do not respond to conventional treatment for disc/facet and are not drug seekers. Are many of them at least somewhat overweight..yes. Do many of them need to change horrible dietary and lifestyle habits..yes. But there is certainly a subset of non chubsters non smokers who seem genuinely frustrated with ongoing symptoms despite treatment and I am reluctant to "sell" them on nevro but I suppose it's worth revisiting. I don't know if I would want a device in my spine for low back pain but I'm also not in their shoes..

But what do you offer those patients? I struggle with this on the regular. I try to tell all my new patients that the goal with treatment is to get to a pain level that doesn't interfere with life, not 0/10. But for most of them, they want 0/10. Telling them to eat better and lose weight and exercise more doesn't work that well for the masses. Hell, even I tune out people that tell my lardass to get off the couch.

 

[Dr. Ice]

But what do you offer those patients? I struggle with this on the regular. I try to tell all my new patients that the goal with treatment is to get to a pain level that doesn't interfere with life, not 0/10. But for most of them, they want 0/10. Telling them to eat better and lose weight and exercise more doesn't work that well for the masses. Hell, even I tune out people that tell my lardass to get off the couch.

Yes it's a daily struggle for me as well. I usually end the conversation with this is what science has to offer and then I will muddle under my breath that "someone will put a stimulator in you if you want.."

 

[Timeoutofmind]

What is this conventional treatment for discogenic pain u guys keep mentioning?

 

[pmrmd]

Chronic myofasical pain exists but it doesn't get better with anything we do. That's the reality and it's a bitter pill to swallow for us and patients.

We're in a different reality. What are you calling myofascial pain? I don't accept the idea of muscle of any kind being painful for weeks/months.

 

[Dr. Ice]

What is this conventional treatment for discogenic pain u guys keep mentioning?

Conventional not the right word. Things like lifestyle mod, PT, ergonomic adjustments at work, ruling out other potential pain generators (facet, diagnostic mbb) and I suppose Ilesi/tfesi for maybe temporary relief.

 

[Dr. Ice]

What I'm saying is that I don't know. I'm using myofascial pain as more of an idea rather than an actuality. If I see a laborer who is doing repetitive bending twisting lifting type of work who is not work comp because there is no specific identifiable injury so his claim would be denied, yes he has a component of likely disc and facet pain but probably also some type of chronic repetitive strain injury to his paraspinal and postural muscles which won't get better with treatment of the deeper structures. That's just an example.[/QUOTE]

 

[lonelobo]

We're in a different reality. What are you calling myofascial pain? I don't accept the idea of muscle of any kind being painful for weeks/months.

guess you have never pulled a hamstring

 

[IN2B8R]

We're in a different reality. What are you calling myofascial pain? I don't accept the idea of muscle of any kind being painful for weeks/months.

Have you ever heard of entities like myositis, dermatomyositis or Sjogren's Syndrome? Maybe a little brushing up would do you good.


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[pmrmd]

Have you ever heard of entities like myositis, dermatomyositis or Sjogren's Syndrome? Maybe a little brushing up would do you good.
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Maybe a little reading comprehension would do you better, noob dingus. The topic is chronic back pain and not proximal limb weakness and atrophy. Look up Sjogren's as well and give me a correlation with axial back pain from that disease entity itself.

Edit: The word I typed wasn't dingus. The site censored my post. The word I typed was azzhole, which you are.

 

[lord_jeebus]

Let's keep the discussion professional, no need for name-calling.

 

[hyperalgesia]

Conclusion: Poorly selected pts with pain in the back area and without standard of care diagnostics don't improve with RFA. This is very useful /s

Conclusion #2: JAMA employs author-selected (biased) and/or unqualified peer reviewers for their pain article submissions.

 

[EtherBunny]

Conclusion: Poorly selected pts with pain in the back area and without standard of care diagnostics don't improve with RFA. This is very useful /s

Conclusion #2: JAMA employs author-selected (biased) and/or unqualified peer reviewers for their pain article submissions.

I couldn't access the full article, just the abstract. Based on the abstract, it's difficult to know the exact details for how patients were allocated to the various treatment arms. For the facet RF arm of the study, the abstract states that the patients underwent diagnostic facet blocks and had a "positive" response. There's no commentary on what approach was used for the blocks (medial branch blocks vs. intra-articular), the threshold for a "positive" response, the number of diagnostic blocks, the local anestheic used, and the volume of injectate at each level. There is no mention of how patients were selected for the facet blocks in the first place.

Did you get a chance to read the full article by any chance? Does anyone have a pdf copy of the full article?

Most of these randomized controlled trials have fairly strict exclusion criteria (ESPECIALLY articles that are selected for publication in JAMA), which makes me question the criticism of poor patient selection inherent to the study. What if the only patients selected for the facet RF arm had "textbook" presentations for facet mediated low back pain? If that's the case, it's hard to dismiss the findings of no statistically significant differences in clinical outcome between exclusively non-interventional approaches (exercise + psychological support alone) vs. interventional combined with non-interventional modalities (exercise + psychological support + RFA).

As an interventional pain physician, obviously I don't like the conclusions, but I also can't ignore the scientific basis of clinical practice. In the final analysis, this is a large, randomized controlled trial that was published in one of the most prestigious academic journals on the planet. Access to the full article here would be awesome.

 

[sloh]

I couldn't access the full article, just the abstract. Based on the abstract, it's difficult to know the exact details for how patients were allocated to the various treatment arms. For the facet RF arm of the study, the abstract states that the patients underwent diagnostic facet blocks and had a "positive" response. There's no commentary on what approach was used for the blocks (medial branch blocks vs. intra-articular), the threshold for a "positive" response, the number of diagnostic blocks, the local anestheic used, and the volume of injectate at each level. There is no mention of how patients were selected for the facet blocks in the first place.

Did you get a chance to read the full article by any chance? Does anyone have a pdf copy of the full article?

Most of these randomized controlled trials have fairly strict exclusion criteria (ESPECIALLY articles that are selected for publication in JAMA), which makes me question the criticism of poor patient selection inherent to the study. What if the only patients selected for the facet RF arm had "textbook" presentations for facet mediated low back pain? If that's the case, it's hard to dismiss the findings of no statistically significant differences in clinical outcome between exclusively non-interventional approaches (exercise + psychological support alone) vs. interventional combined with non-interventional modalities (exercise + psychological support + RFA).

As an interventional pain physician, obviously I don't like the conclusions, but I also can't ignore the scientific basis of clinical practice. In the final analysis, this is a large, randomized controlled trial that was published in one of the most prestigious academic journals on the planet. Access to the full article here would be awesome.

"Methods
11 was an initiative to evaluate minimally invasive treatments for patients with spinal column–related chronic low back pain, consisting of 4 trials and an observational study (participants who did not want to be randomized or who did not meet the inclusion criteria for the trials were asked to participate in the observational study, where they received usual care). The full protocol is available in Supplement 1. One trial was designed to evaluate radiofrequency denervation for pain from the intervertebral disks. This trial was prematurely terminated because of a lack of eligible participants. The other 3 trials are presented in this article: (1) the facet joint trial, (2) the sacroiliac joint trial, and (3) the combination trial (facet joint, sacroiliac joint, or the intervertebral disk). The Medical Ethics Committee of the Erasmus University Medical Centre in Rotterdam granted ethical approval. Local research governance was obtained from all participating pain clinics. All participants gave written informed consent.

12,13 Participants with suspected isolated facet joint pain or isolated sacroiliac joint pain received a diagnostic anesthetic block prior to randomization and were only randomized if the diagnostic block was positive. Participants with a suspected combination of sources of pain were randomized based on participant history and physical examination prior to receiving the diagnostic blocks. This choice was made for ethical reasons. It would be unethical to give participants in the study multiple diagnostic blocks (ie, a facet joint diagnostic block, a sacroiliac joint diagnostic block, and a provocative discography) before treatment. Furthermore, it is common practice in Dutch pain clinics for participants with chronic low back pain due to facet joints, sacroiliac joints, or intervertebral disks (based on history taking and physical examination) to start with 1 diagnostic block. If the diagnostic block was positive, the intervention was provided. If the diagnostic block was negative, then another block was provided. If the second diagnostic block was positive, the intervention was provided. If the second diagnostic block was negative, the clinician provided a third block. All participants were considered candidates for intervention based on history taking and physical examination. For this reason, participants were randomized and included in the combination trial after history taking and physical examination, if the pain physician suspected that the pain originated from more than 1 source.

14 a 22-gauge needle was inserted to the posterior primary root of the spinal nerve (medial branch) under C-arm fluoroscopy. L3-4, L4-5, and L5-6 were selected for diagnostic blocks. The lateral image was checked to confirm the correct position of the needle, after which 0.5 mL of 2% lidocaine was injected.

 

[sloh]

Continued from post above:

"
For the sacroiliac joints,14 a 25-gauge needle was inserted 3 mm to 10 mm laterally of the sacral foramina S1-3 under fluoroscopy. The correct depth of the needle was confirmed laterally, after which 0.5 mL of 2% lidocaine was injected. The dorsal ramus of L5 was also blocked as described in the Spinal Intervention Society guidelines using 0.5 mL of 2% lidocaine.

The blocks were considered positive if the participant reported 50% or more pain reduction within 30 to 90 minutes after the block.

The current standard for diagnosing discogenic pain is pressure-controlled provocative discography using strict criteria and at least 1 negative control level.15"

 

[Ducttape]

this was metanalysis. multiple studies combined to try to draw conclusions favorable to the authors' position.

the blocks were + if 50%, not 80%. this would increase % of false positives. if 1st one negative, 2nd one done. makes no sense, as if the block were negative, shouldnt they have been eliminated from the study and not been enrolled? in addition, did not follow with 2 block criteria for RFA.


so for us, this changes nothing because it was a poor quality "study" - or more, 4 different studies, one which was terminated because of lack of eligible participants.

unfortunately, the lay public and non-interventional spine (and Medicare advisors) will only point out the lack of efficacy in this poorly designed study.

 

[DOctorJay]

single blocks
used 22 gauge cannulas and single burns for the RFA procedures (see supplement 2)
as Steve mentioned, GIGO

 

[IN2B8R]

We're in a different reality. What are you calling myofascial pain? I don't accept the idea of muscle of any kind being painful for weeks/months.

Quoting your previous post: "I don't accept the idea of muscle of ANY kind being painful for weeks/months." Judging by your thoughtless response, I think that I am better off ignoring you.


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[bedrock]

single blocks
used 22 gauge cannulas and single burns for the RFA procedures (see supplement 2)
as Steve mentioned, GIGO

Agree total GIGO study.

Completely different situation that the Dreyfuss RFA studies. If someone were to repeat his studies. (double MBB with only 0.3ml of medication, 80% relief required for RFA, and RFA with 18G cannulae), then the study outcomes would be similar to Dreyfuss papers.

 

[lobelsteve]

Members of the Spine Intervention Society’s Standards Division have identified significant shortcomings with patient selection and technique used in a recent lumbar radiofrequency neurotomy study out of the Netherlands by Juch et al. The study derives erroneous conclusions about the effectiveness of lumbar radiofrequency neurotomy and unfortunately some insurers may try to use it to limit coverage, relegating patients to continued suffering and/or dependence on opioids.

Inherent Bias Potential
Because this unblinded study was funded in part by grant money received from Dutch health insurance companies, SIS is concerned about the potential risk of bias arising from this possible conflict of interest.

Inadequate Diagnostic Assessment
The study selected patients for radiofrequency neurotomy (RFN) based on inadequate diagnostic assessment. For that reason, many patients treated with RFN likely did not have facet joint or sacroiliac joint pain, and would not have been expected to experience pain relief or functional improvement.

Ineffective Technique Selection
The lumbar medial branch radiofrequency neurotomy technique employed in the Juch study used a small gauge (22G) electrode with positioning inconsistent with the “parallel technique” as described in the SIS Guidelines, wherein large gauge radiofrequency electrodes have been established as effective in providing pain relief for patients with lumbar facet joint pain. The small lesions employed in the Dutch study most likely missed many of the targeted nerves and would not be expected to relieve pain from the lumbar facet joints.

The Society is currently preparing a formal response and hopes to see it published in the Journal of the American Medical Association.


Stay tuned for more information and discuss with your colleagues in San Francisco next week at the SIS Annual Meeting, #SIS25th.

















About SIS

The Spine Intervention Society, or SIS (pronounced "ESS-EYE-ESS") was formerly known as the International Spine Intervention Society. SIS has over 2,600 physician members in 42 countries and has been providing high quality spine care information for over 25 years.


Contact Info

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120 E. Ogden Ave. Ste. 202
Hinsdale, Illinois 60521
630.203.2252
SpineIntervention.org

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[drusso]

Members of the Spine Intervention Society’s Standards Division have identified significant shortcomings with patient selection and technique used in a recent lumbar radiofrequency neurotomy study out of the Netherlands by Juch et al. The study derives erroneous conclusions about the effectiveness of lumbar radiofrequency neurotomy and unfortunately some insurers may try to use it to limit coverage, relegating patients to continued suffering and/or dependence on opioids.

Inherent Bias Potential
Because this unblinded study was funded in part by grant money received from Dutch health insurance companies, SIS is concerned about the potential risk of bias arising from this possible conflict of interest.

Inadequate Diagnostic Assessment
The study selected patients for radiofrequency neurotomy (RFN) based on inadequate diagnostic assessment. For that reason, many patients treated with RFN likely did not have facet joint or sacroiliac joint pain, and would not have been expected to experience pain relief or functional improvement.

Ineffective Technique Selection
The lumbar medial branch radiofrequency neurotomy technique employed in the Juch study used a small gauge (22G) electrode with positioning inconsistent with the “parallel technique” as described in the SIS Guidelines, wherein large gauge radiofrequency electrodes have been established as effective in providing pain relief for patients with lumbar facet joint pain. The small lesions employed in the Dutch study most likely missed many of the targeted nerves and would not be expected to relieve pain from the lumbar facet joints.

The Society is currently preparing a formal response and hopes to see it published in the Journal of the American Medical Association.

Stay tuned for more information and discuss with your colleagues in San Francisco next week at the SIS Annual Meeting, #SIS25th.

About SIS

The Spine Intervention Society, or SIS (pronounced "ESS-EYE-ESS") was formerly known as the International Spine Intervention Society. SIS has over 2,600 physician members in 42 countries and has been providing high quality spine care information for over 25 years.


Contact Info

Spine Intervention Society
120 E. Ogden Ave. Ste. 202
Hinsdale, Illinois 60521
630.203.2252
SpineIntervention.org

Contact

Copyright © 2017 Spine Intervention Society
All rights reserved.

This is a useful scientific critique of a bonafide pain treatment, but utterly meaningless in the current practice landscape. Payers will continue to ration and deny spine and pain care for POLITICAL reasons not scientific ones. Population-based medical stakeholders desire that pain (or altered comfort) be a psychologized character problem (a foible of life) rather than a legitimate health or medical condition that requires treatment. In this view, altered comfort is more akin to low self-esteem or poor body image (aesthetics) than diabetes, hypertension, or inflammatory arthritis.

As long as population-based thought leaders are perpetuating this worldview, arguing for a scientific basis for any treatment of a pain condition is simply a non-starter...just pissing in the wind. The organized pain and spine professional societies should stop pretending that they are fighting a scientific battle based upon evidence and clear "rules of engagement" and instead realize that they are embroiled in cultural Guerrilla warfare-type battle for legitimacy.

 

[lobelsteve]

This is a useful scientific critique of a bonafide pain treatment, but utterly meaningless in the current practice landscape. Payers will continue to ration and deny spine and pain care for POLITICAL reasons not scientific ones. Population-based medical stakeholders desire that pain (or altered comfort) be a psychologized character problem (a foible of life) rather than a legitimate health or medical condition that requires treatment. In this view, altered comfort is more akin to low self-esteem or poor body image (aesthetics) than diabetes, hypertension, or inflammatory arthritis.

As long as population-based thought leaders are perpetuating this worldview, arguing for a scientific basis for any treatment of a pain condition is simply a non-starter...just pissing in the wind. The organized pain and spine professional societies should stop pretending that they are fighting a scientific battle based upon evidence and clear "rules of engagement" and instead realize that they are embroiled in cultural Guerrilla warfare-type battle for legitimacy.

You shoot the ketamine dart, I will tie the silk suture on their sciatic nerve. Anyone got a hot plate we could borrow?

 

[DOctorJay]

Guys come over to SERMO and start commenting on similar thread regarding this study


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[clubdeac]

Seriously we need to ban together in some type of class action lawsuit or something. This study was clearly biased! Funded by the insurance companies to be used by the ****ing insurance companies! At the very least this is a laughable study. At the worst pure deception

 

[NJPAIN]

Our specialty is clearly in the center of the bullseye. If we don't do something quickly in a cohesive fashion we will have nothing left in our armamentarium that insurance will pay for. We will be left with one "treatment" and that will be advising patient to " suck it up".


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[DOctorJay]

Good grief

Radiofrequency Denervation Offers No Benefits for Back Pain


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[lobelsteve]

Good grief

Radiofrequency Denervation Offers No Benefits for Back Pain


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Oops, you forgot to read the comments from patients saying how good RF worked for them and how crappy the article was.

 

[DOctorJay]

No I did read the comments and almost posted how surprised I was that the comments section to one of these articles was actually logical for once. Then I got lazy. Thanks for pointing it out though!


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[hyperalgesia]

It just occurred to me that insurance and medicare refusing to pay for this procedure could be the best thing ever to happen to our field. A truly effective cash-only procedure. The LASIK of Pain Management...

 

[NJPAIN]

It just occurred to me that insurance and medicare refusing to pay for this procedure could be the best thing ever to happen to our field. A truly effective cash-only procedure. The LASIK of Pain Management...

I can only HOPE that you are correct.

 

[clubdeac]

Seriously though are any of you guys writing a response to the article and sending it to JAMA. I really hope some docs are sending their thoughts

 

[lobelsteve]

Seriously though are any of you guys writing a response to the article and sending it to JAMA. I really hope some docs are sending their thoughts

SIS is writing our response.

 

[drusso]

It just occurred to me that insurance and medicare refusing to pay for this procedure could be the best thing ever to happen to our field. A truly effective cash-only procedure. The LASIK of Pain Management...

The best thing that any Pain Physician can do is exit the third-party payor system, go direct access, "right-size" their practices (imagine no pre-auth, office-based procedure suite, etc) and offer personalized care for cash. This is not just for survival, it's what the population-based health thinkers (Chou, Deyo, et al) want when they imagine the next iteration of the health care system. They WANT the pain/spine specialty to be like dental implants, cosmetic surgery, LASIK, and varicose vein treatment centers. Let the PCP's and ACO's struggle with the government payers. The PP's can stick to cash.

 

[drusso]

SIS is writing our response.

I hope that they address the socio-economic and political forces driving the promulgation of GIGO pain studies and not just the technical and scientific merits. No one in any decision making capacity cares about the latter.