L TESI Dex: A Prospective, Randomized, Double-Blind, Dose-Response Trial

[ampaphb]

Lumbar Transforaminal Epidural Dexamethasone: A Prospective, Randomized, Double-Blind, Dose-Response Trial
Ahadian FM, McGreevy K, Schulteis G.
Reg Anesth Pain Med. 2011 Oct 14. [Epub ahead of print]
http://www.ncbi.nlm.nih.gov/pubmed/22005659

Abstract
BACKGROUND AND OBJECTIVES:
Serious adverse events related to particulate steroids have curtailed the use of transforaminal epidural steroid injections for radicular pain. Dexamethasone has been proposed as an alternative. We investigated the efficacy, dose-response profile, and safety of 3 doses of epidural dexamethasone.

METHODS:
A prospective, randomized, double-blind, dose-ranging design was used. A total of 98 subjects were randomized to transforaminal epidural dexamethasone 4 mg (n = 33), 8 mg (n = 33), or 12 mg (n = 32). The primary outcome measure for this study was reduction in radicular pain according to the visual analog scale from baseline, with 30% reduction or higher considered clinically meaningful. Secondary measures included the Oswestry Low Back Disability Scale, Subject Global Impression of Change, Subject Global Satisfaction Scale, and adverse events. Outcomes were assessed at 1, 4, 8, and 12 weeks after injection. Outcome measures, sample size, and statistical analysis were defined before enrollment.

RESULTS:
Mean radicular pain according to the visual analog scale compared with baseline was reduced 41.7%, 33.5%, and 26.6% at 4, 8, and 12 weeks, respectively, after injection. Oswestry disability ratings declined from "moderate" at baseline to "minimal" at 4, 8, and 12 weeks after injection. There was no statistical difference between groups for either measure (all P values < 0.05, Bonferroni-corrected). Parallel effects were observed in "impression of change" and "satisfaction" measures. No serious adverse events were noted.

CONCLUSIONS:
Transforaminal epidural dexamethasone provides statistically significant and clinically meaningful improvement in radicular pain at 12 weeks after injection, with parallel improvements in disability, impression of change, and satisfaction measures. There was no difference in efficacy for dexamethasone 4 mg compared with 8 or 12 mg. The optimal dose of epidural dexamethasone may be lower than 4 mg, further increasing the long-term safety and tolerability of this treatment. Current data are reassuring with regard to the safety of dexamethasone for transforaminal epidural steroid injection.

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[lobelsteve]

Lumbar Transforaminal Epidural Dexamethasone: A Prospective, Randomized, Double-Blind, Dose-Response Trial
Ahadian FM, McGreevy K, Schulteis G.
Reg Anesth Pain Med. 2011 Oct 14. [Epub ahead of print]
http://www.ncbi.nlm.nih.gov/pubmed/22005659

Abstract
BACKGROUND AND OBJECTIVES:
Serious adverse events related to particulate steroids have curtailed the use of transforaminal epidural steroid injections for radicular pain. Dexamethasone has been proposed as an alternative. We investigated the efficacy, dose-response profile, and safety of 3 doses of epidural dexamethasone.

METHODS:
A prospective, randomized, double-blind, dose-ranging design was used. A total of 98 subjects were randomized to transforaminal epidural dexamethasone 4 mg (n = 33), 8 mg (n = 33), or 12 mg (n = 32). The primary outcome measure for this study was reduction in radicular pain according to the visual analog scale from baseline, with 30% reduction or higher considered clinically meaningful. Secondary measures included the Oswestry Low Back Disability Scale, Subject Global Impression of Change, Subject Global Satisfaction Scale, and adverse events. Outcomes were assessed at 1, 4, 8, and 12 weeks after injection. Outcome measures, sample size, and statistical analysis were defined before enrollment.

RESULTS:
Mean radicular pain according to the visual analog scale compared with baseline was reduced 41.7%, 33.5%, and 26.6% at 4, 8, and 12 weeks, respectively, after injection. Oswestry disability ratings declined from "moderate" at baseline to "minimal" at 4, 8, and 12 weeks after injection. There was no statistical difference between groups for either measure (all P values < 0.05, Bonferroni-corrected). Parallel effects were observed in "impression of change" and "satisfaction" measures. No serious adverse events were noted.

CONCLUSIONS:
Transforaminal epidural dexamethasone provides statistically significant and clinically meaningful improvement in radicular pain at 12 weeks after injection, with parallel improvements in disability, impression of change, and satisfaction measures. There was no difference in efficacy for dexamethasone 4 mg compared with 8 or 12 mg. The optimal dose of epidural dexamethasone may be lower than 4 mg, further increasing the long-term safety and tolerability of this treatment. Current data are reassuring with regard to the safety of dexamethasone for transforaminal epidural steroid injection.

3 months? What? 4mg? Huh? Looks like I can add less and save money.

 

[101N]

Lumbar Transforaminal Epidural Dexamethasone: A Prospective, Randomized, Double-Blind, Dose-Response Trial
Ahadian FM, McGreevy K, Schulteis G.
Reg Anesth Pain Med. 2011 Oct 14. [Epub ahead of print]
http://www.ncbi.nlm.nih.gov/pubmed/22005659

Abstract
BACKGROUND AND OBJECTIVES:
Serious adverse events related to particulate steroids have curtailed the use of transforaminal epidural steroid injections for radicular pain. Dexamethasone has been proposed as an alternative. We investigated the efficacy, dose-response profile, and safety of 3 doses of epidural dexamethasone.

METHODS:
A prospective, randomized, double-blind, dose-ranging design was used. A total of 98 subjects were randomized to transforaminal epidural dexamethasone 4 mg (n = 33), 8 mg (n = 33), or 12 mg (n = 32). The primary outcome measure for this study was reduction in radicular pain according to the visual analog scale from baseline, with 30% reduction or higher considered clinically meaningful. Secondary measures included the Oswestry Low Back Disability Scale, Subject Global Impression of Change, Subject Global Satisfaction Scale, and adverse events. Outcomes were assessed at 1, 4, 8, and 12 weeks after injection. Outcome measures, sample size, and statistical analysis were defined before enrollment.

RESULTS:
Mean radicular pain according to the visual analog scale compared with baseline was reduced 41.7%, 33.5%, and 26.6% at 4, 8, and 12 weeks, respectively, after injection. Oswestry disability ratings declined from "moderate" at baseline to "minimal" at 4, 8, and 12 weeks after injection. There was no statistical difference between groups for either measure (all P values < 0.05, Bonferroni-corrected). Parallel effects were observed in "impression of change" and "satisfaction" measures. No serious adverse events were noted.

CONCLUSIONS:
Transforaminal epidural dexamethasone provides statistically significant and clinically meaningful improvement in radicular pain at 12 weeks after injection, with parallel improvements in disability, impression of change, and satisfaction measures. There was no difference in efficacy for dexamethasone 4 mg compared with 8 or 12 mg. The optimal dose of epidural dexamethasone may be lower than 4 mg, further increasing the long-term safety and tolerability of this treatment. Current data are reassuring with regard to the safety of dexamethasone for transforaminal epidural steroid injection.

Good to know. Thanks.

Do you know if ISIS or NASS plan to a statement or recommendations on non-particulate steroids for ALL TFESIs?

 

[epidural man]

Hey!

I was just coming here to post that. Beat me too it...

Similar study (I posted somewhere on here) that showed that triamcinolone dose didn't matter either - 10mg as good as 80mg or something like that.

But where is DSA in all these discussions? Can I use particulate if I use DSA? Come on ISIS - say something about that.

I would have liked them to use a triamcinolone arm - compare head to head.

 

[Ligament]

Sorry, I don't buy this. Have already gone the Dex for everything route and it does not work as long as Kenalog. Can't comment on other particulates. I think most of us have been through this already, right?

 

[101N]

Sorry, I don't buy this. Have already gone the Dex for everything route and it does not work as long as Kenalog. Can't comment on other particulates. I think most of us have been through this already, right?

This has been my gestalt as well. I'm sill usin Susan Dryer's recs from her
Spine Line article: no particulate above L3.

 

[lobelsteve]

This has been my gestalt as well. I'm sill usin Susan Dryer's recs from her
Spine Line article: no particulate above L3.

THat seems stupid based on the data we have. Those vessels can be as low as S1 and the $1M case reprots are out there. Is it less risky above L3- yes, but it is still a risk at S1. I have not seen any difference between Celestone or Dex.

 

[SSdoc33]

THat seems stupid based on the data we have. Those vessels can be as low as S1 and the $1M case reprots are out there. Is it less risky above L3- yes, but it is still a risk at S1. I have not seen any difference between Celestone or Dex.

if you are gonna inject dex and dose doesnt matter, why not just inject saline. i have to think that the particulates last longer. they have to. right?

 

[bedrock]

THat seems stupid based on the data we have. Those vessels can be as low as S1 and the $1M case reprots are out there. Is it less risky above L3- yes, but it is still a risk at S1. I have not seen any difference between Celestone or Dex.

Celestone is closer to dex than it is to Kenalog/Depo-medrol. I've seen noticeably decreased treatment duration when switching from kenalog to either celestone or dex-

The key feature that everyone seems to miss, including ISIS, is DSA.
Show me a $1M case report of a significant adverse reaction caused by a TFESI with particulate, injected after clean DSA imaging. Why.......because it doesn't exist.

I do use dex for the higher level TFESI, but I get great results doing L4, L5, and S1 TTESI with triamcinolone, (with DSA imaging).
There is no scientific evidence arguing that lumbar TFESI with appropriate DSA imaging is unsafe, just opinions from those who don't use DSA or are unfamiliar with it.

 

[lobelsteve]

if you are gonna inject dex and dose doesnt matter, why not just inject saline. i have to think that the particulates last longer. they have to. right?

Mean radicular pain according to the visual analog scale compared with baseline was reduced 41.7%, 33.5%, and 26.6% at 4, 8, and 12 weeks, respectively, after injection. Oswestry disability ratings declined from "moderate" at baseline to "minimal" at 4, 8, and 12 weeks after injection. There was no statistical difference between groups for either measure (all P values < 0.05, Bonferroni-corrected). Parallel effects were observed in "impression of change" and "satisfaction" measures. No serious adverse events were noted.

That trend looks like it is progressing to not meaningful at 8-12 weeks. The proposed theory that the sticky and slowly dissolving crystals appears scientifically valid. But if I can get 4 weeks of good relief for the ESI, then the DLS program can take over for my radics and stenotic patient. And I try and avoid ESI for anyone that does not fit this picture.

 

[SSdoc33]

Mean radicular pain according to the visual analog scale compared with baseline was reduced 41.7%, 33.5%, and 26.6% at 4, 8, and 12 weeks, respectively, after injection. Oswestry disability ratings declined from "moderate" at baseline to "minimal" at 4, 8, and 12 weeks after injection. There was no statistical difference between groups for either measure (all P values < 0.05, Bonferroni-corrected). Parallel effects were observed in "impression of change" and "satisfaction" measures. No serious adverse events were noted.

That trend looks like it is progressing to not meaningful at 8-12 weeks. The proposed theory that the sticky and slowly dissolving crystals appears scientifically valid. But if I can get 4 weeks of good relief for the ESI, then the DLS program can take over for my radics and stenotic patient. And I try and avoid ESI for anyone that does not fit this picture.

i guess. thats a nice theory, but how is your 80 y/o little old lady going to do with your dynamic lumbar stabilization protocol? she needs a long-lasting steroid to keep her ambulating.