Local vs Local & Steroid for Lumbar Facet Nerve Blocks

[dc2md]

Thoughts??

http://www.ncbi.nlm.nih.gov/pubmed/20567613

Abstract

Study Design: A randomized, double-blind, controlled trial.

Objective: To determine the clinical effectiveness of therapeutic lumbar facet joint nerve blocks with or without steroids in managing chronic low back pain of facet joint origin.

Summary of Background Data: Lumbar facet joints have been shown as the source of chronic pain in 21% to 41% of low back patients with an average prevalence of 31% utilizing controlled comparative local anesthetic blocks. Intraarticular injections, medial branch blocks, and radiofrequency neurotomy of lumbar facet joint nerves have been described in the alleviation of chronic low back pain of facet joint origin.

Methods: The study included 120 patients with 60 patients in each group with local anesthetic alone or local anesthetic and steroids. The inclusion criteria was based upon a positive response to diagnostic controlled, comparative local anesthetic lumbar facet joint blocks.
Outcome measures included the numeric rating scale (NRS), Oswestry Disability Index (ODI), opioid intake, and work status, at baseline, 3, 6, 12, 18, and 24 months.

Results: Significant improvement with significant pain relief of ≥ 50% and functional improvement of ≥ 40% were observed in 85% in Group 1, and 90% in Group II, at 2-year follow- up.

The patients in the study experienced significant pain relief for 82 to 84 weeks of 104 weeks, requiring approximately 5 to 6 treatments with an average relief of 19 weeks per episode of treatment.

Conclusions: Therapeutic lumbar facet joint nerve blocks, with or without steroids, may provide a management option for chronic function-limiting low back pain of facet joint origin.

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[SleepIsGood]

Thoughts??

http://www.ncbi.nlm.nih.gov/pubmed/20567613

Abstract

Study Design: A randomized, double-blind, controlled trial.

Objective: To determine the clinical effectiveness of therapeutic lumbar facet joint nerve blocks with or without steroids in managing chronic low back pain of facet joint origin.

Summary of Background Data: Lumbar facet joints have been shown as the source of chronic pain in 21% to 41% of low back patients with an average prevalence of 31% utilizing controlled comparative local anesthetic blocks. Intraarticular injections, medial branch blocks, and radiofrequency neurotomy of lumbar facet joint nerves have been described in the alleviation of chronic low back pain of facet joint origin.

Methods: The study included 120 patients with 60 patients in each group with local anesthetic alone or local anesthetic and steroids. The inclusion criteria was based upon a positive response to diagnostic controlled, comparative local anesthetic lumbar facet joint blocks.
Outcome measures included the numeric rating scale (NRS), Oswestry Disability Index (ODI), opioid intake, and work status, at baseline, 3, 6, 12, 18, and 24 months.

Results: Significant improvement with significant pain relief of ≥ 50% and functional improvement of ≥ 40% were observed in 85% in Group 1, and 90% in Group II, at 2-year follow- up.

The patients in the study experienced significant pain relief for 82 to 84 weeks of 104 weeks, requiring approximately 5 to 6 treatments with an average relief of 19 weeks per episode of treatment.

Conclusions: Therapeutic lumbar facet joint nerve blocks, with or without steroids, may provide a management option for chronic function-limiting low back pain of facet joint origin.

same literature is out there for tranforaminals.

the thought is the inflammatory mediators are 'washed out'.

 

[pmrmd]

same literature is out there for tranforaminals.

the thought is the inflammatory mediators are 'washed out'.

"washed out" of the nerve? please. its news to me that the medial branch is inflamed. how about using some objective measurements to gauge success?

 

[dc2md]

same literature is out there for tranforaminals.

the thought is the inflammatory mediators are 'washed out'.

Here's what Lax et al. say in the article:

"Local anesthetics have been postulated to provide relief by various mechanisms including suppression of nociceptive discharge,70 the blockade of the axonal transport,72,73 the block of
the sympathetic reflex arc and sensitization,74,75 and anti-inflammatory effects.76
The long-term effectiveness of local anesthetics has been shown in a host of previous studies as a result of local anesthetic nerve blocks or epidural injections.36,38-42,77

And here are the references noted above:

70. Arner S, Lindblom U, Meyerson BA, et al. Prolonged relief of
neuralgia after regional anesthetic block. A call for further experimental
and systematic clinical studies. Pain. 1990; 43:287-97.

72. Bisby MA. Inhibition of axonal transport in nerves chronically
treated with local anesthetics. Exp Neurol. 1975; 47: 481-89.

73. Lavoie PA, Khazen T, Filion PR. Mechanisms of the inhibition
of fast axonal transport by local anesthetics. Neuropharmacology.
1989; 28: 175-81.

74. Katz WA, Rothenberg R. The nature of pain: Pathophysiology. J
Clin Rheumatol. 2005; 11: S11-5.

75. Melzack R, Coderre TJ, Katz J, et al. Central neuroplasticity and
pathological pain. Ann N Y Acad Sci. 2001; 933: 157-74.

77. Riew KD, Park JB, Cho YS, et al. Nerve root blocks in the
treatment of lumbar radicular pain. A minimum five-year follow-
up. J Bone Joint Surg Am. 2006; 88: 1722-5.

36. Manchikanti L, Singh V, Falco FJE, et al. Cervical medial branch
blocks for chronic cervical facet joint pain: A randomized
double-blind, controlled trial with one-year follow-up. Spine
(Phila PA 1976). 2008; 33: 1813-20.

38. Manchikanti L, Singh V, Falco FJE, et al. Effectiveness of thoracic
medial branch blocks in managing chronic pain: A preliminary
report of a randomized, double-blind controlled trial;
Clinical trial NCT00355706. Pain Physician. 2008; 11: 491-504.

39. Manchikanti L, Cash KA, McManus CD, et al. Preliminary
results of randomized, equivalence trial of fluoroscopic caudal
epidural injections in managing chronic low back pain: Part 1.
Discogenic pain without disc herniation or radiculitis. Pain
Physician. 2008; 11: 785-800.

40. Manchikanti L, Singh V, Cash KA, et al. Preliminary results of
randomized, equivalence trial of fluoroscopic caudal epidural
injections in managing chronic low back pain: Part 2. Disc herniation
and radiculitis. Pain Physician. 2008; 11: 801-15.

41. Manchikanti L, Singh V, Cash KA, et al. Preliminary results of
randomized, equivalence trial of fluoroscopic caudal epidural
injections in managing chronic low back pain: Part 3. Post surgery
syndrome. Pain Physician. 2008; 11: 817-31.

42. Manchikanti L, Cash KA, McManus CD, et al. Preliminary
results of randomized, equivalence trial of fluoroscopic caudal epidural injections in managing chronic low back pain: Part 4.
Spinal stenosis. Pain Physician. 2008; 11: 833-48.

Lax definitely quotes his own studies a lot here. I'm not saying that's necessarily a bad thing.

 

[Aether2000]

One of the most important factors in evaluating a study is the author. In this case, the author is known to have published similar studies showing years of relief from thoracic medial branch blocks. It is likely there is a flaw in controlling the variables in the patients in both studies and there is an attributed long-term effect to the block that is really non-existent. Also, anytime an author is heavily involved in the promotion of the politics and reimbursement for these procedures, any scientific studies should be scrutinized for bias or misrepresentation, and whether this type of study is reproducible by other authors. I know of several studies that demonstrate short term relief only from IA facet injections but this is a sui generis in providing 2 year relief. Does this study pass the sniff test? No way. Studies that are perceived to be outliers or fabricated actually do more damage to the validity and ethics of interventional pain medicine than they do good, and call into question the methodology employed by pain physicians in general in the conduct of their studies. Only if this study is reproduced by authors that lack a primary motivation of increasing revenues for pain procedures would I find this study to have merit.

 

[dc2md]

Good to know. Thanks Algos.

 

[SleepIsGood]

One of the most important factors in evaluating a study is the author. In this case, the author is known to have published similar studies showing years of relief from thoracic medial branch blocks. It is likely there is a flaw in controlling the variables in the patients in both studies and there is an attributed long-term effect to the block that is really non-existent. Also, anytime an author is heavily involved in the promotion of the politics and reimbursement for these procedures, any scientific studies should be scrutinized for bias or misrepresentation, and whether this type of study is reproducible by other authors. I know of several studies that demonstrate short term relief only from IA facet injections but this is a sui generis in providing 2 year relief. Does this study pass the sniff test? No way. Studies that are perceived to be outliers or fabricated actually do more damage to the validity and ethics of interventional pain medicine than they do good, and call into question the methodology employed by pain physicians in general in the conduct of their studies. Only if this study is reproduced by authors that lack a primary motivation of increasing revenues for pain procedures would I find this study to have merit.

I agree that one should scrutinize ANY study. There are individuals that are not part of this above named study that routinely do not use steroids for TFESI. They have stated in their experience whether steroid was used or not, the results were equivocal. So why take the risk of adding steroids is their premise.

Also, people take normal saline to be equivalent to a 'placebo'. Again, at these conferences (ie not just ASIPP), there are individuals that will state normal saline is not a 'placebo' and actually does have therapeutic benefit. Whether it is 'washing out' the inflammatory mediators, or otherwise (clearly the MOA is not known).

While I do not know where I stand with all the above stated, it seems reasonable to atleast entertain these ideas and to ponder about their ramifications.

 

[Aether2000]

After re-reading the study abstract it appears that there wasn't a 2 year followup after treatment: it was a 2 year on going study with injections every 19 weeks. The correct terminology should have been followup 19 weeks after the last treatment. Therefore the relief was not the implied 82 weeks but was actually less than 19 weeks, which is consistent with other authors. It was not a 2 year followup from the last treatment but was from the beginning of the series of treatments, therefore is irrelevant. It would be interesting to see the patient cost for such treatments for someone who owns their own surgery center like the author of this paper.... Guys in my area charge and collect from the patients $4,000 facility fee plus the physician fee for each set of facet injections. Multiply that times 6 injections over 2 years and we are talking about real money here...

 

[dc2md]

Therefore the relief was not the implied 82 weeks but was actually less than 19 weeks, which is consistent with other authors.

Taking the exorbitant surgery center fees out of it (I agree with algos, that's ridiculous. Like $40 for a single aspirin in the hospital), for 85% of the patients to have significant pain relief for 82 weeks out of 104 weeks (2 yrs) with only 5-6 blocks seems pretty darn good. And since it was just as good as the local+steroids group, it does beg the question, why.

Maybe it is all about inflammatory mediators that are washed away with ANY fluid, and the pain only comes back once they build up again. Maybe it is similar to the effects seen after a stellate ganglion block for CRPS lasting much longer than the local anesthetic effects.

I'm not even a fellow yet, but I hope we get this answered some day.

 

[Aether2000]

Makes you wonder what would happen if we placed an anterior epidural space catheter and infused saline continuously over a year for discogenic disease....perhaps it would actually work...

 

[SleepIsGood]

Taking the exorbitant surgery center fees out of it (I agree with algos, that's ridiculous. Like $40 for a single aspirin in the hospital), for 85% of the patients to have significant pain relief for 82 weeks out of 104 weeks (2 yrs) with only 5-6 blocks seems pretty darn good. And since it was just as good as the local+steroids group, it does beg the question, why.

Maybe it is all about inflammatory mediators that are washed away with ANY fluid, and the pain only comes back once they build up again. Maybe it is similar to the effects seen after a stellate ganglion block for CRPS lasting much longer than the local anesthetic effects.

I'm not even a fellow yet, but I hope we get this answered some day.

Pain is a very complex problem. We need research to discern the 'whys' sometimes. Although a crude analogy, think about this. Your computer screen is frozen, for example you get that 'blue screen'. You turn the computer off, and then turn it on again and it works completely fine again. You've 'resetted' the computer.

I'm not saying one should go around 'resetting' things by blocks. But is that what we are essentially doing in cases like stellate ganglion blocks that work longer than the local anesthetic injected? I dont know.

 

[dc2md]

We need to keep in mind that they perform "facet joint nerve blocks", not intra-articular or periarticular injections (even though with the 1.5ml of total injectate used sometimes, he probably did get some local and steroids periarticular). He never uses the words "medial branch blocks" when describing his methods, but I think we can assume that's what he means. And it never states the levels treated, but he only included patients that had successful lidocaine blocks first, followed by bupivacaine blocks.

So this study does NOT conclude that intraarticular local is just as efficacious as intraarticular steroids. Just wanted to make that clear.

And it doesn't mention which steroids were used, and how many mg's of the steroid was used. You obviously can't expect too much of an effect from 0.1ml of methylprednisolone (40mg/ml). So that's interesting information not to include.

But regardless, the results are interesting, and worthy of a discussion.

 

[Tenesma]

1) i agree w/ the first premise that a study by a guy who is promoting reimbursements for the procedure is something to be careful with from a scientific point of view

2) however, NOBODY else is doing the amount of studies he is doing..... we are all big talkers --- but none of us are producing a lot of data to help support or counter our regular recommendations to patients.

 

[Mister Mxyzptlk]

1) i agree w/ the first premise that a study by a guy who is promoting reimbursements for the procedure is something to be careful with from a scientific point of view

2) however, NOBODY else is doing the amount of studies he is doing..... we are all big talkers --- but none of us are producing a lot of data to help support or counter our regular recommendations to patients.

It's not just "a study by a guy who is promoting reimbursements for the procedure". It's that particular guy.

As for the research, I am hard pressed to name another specialty where the responsibility to do research is placed so much on the private practitioners.

 

[Tenesma]

i think any young specialty is going to go through the same difficulties re: proving efficacy....

the older specialties --- their procedures are all grandfathered into accepted standard of care.... look at ortho --- arthroscopies never got a reimbursement hit despite several studies showing them to be useless compared to placebo...

 

[Aether2000]

I agree Lax does more studies, arguably more than anyone else in Pain Medicine. No question.

 

[Mister Mxyzptlk]

I agree Lax does more studies, arguably more than anyone else in Pain Medicine. No question.

“There is a great discovery still to be made in literature, that of paying literary men by the quantity they do not write”

Thomas Carlyle

 

[Aether2000]

lol...