Caudal no benefit for acute sciatica

[lobelsteve]

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No Efficacy of Dexamethasone Injections for Acute Sciatica: A Double-Blind Randomized Study Versus Saline​

ABSTRACT​

Background​

The efficacy of caudal injections for patients with acute sciatica remains controversial. The DEXHIA study was designed to evaluate whether ultrasound-guided caudal injection of dexamethasone provides superior clinical outcomes compared with saline placebo.

Methods​

This prospective, randomized, placebo-controlled, double-blind trial included adult patients with sciatica secondary to lumbar disc herniation of less than 3 months' duration. Participants were randomly assigned in a 1:1 ratio to receive either 16 mg of dexamethasone (4 mL) diluted with 16 mL of saline (DEXA group) or 20 mL of saline alone (PLACEBO group), administered by ultrasound-guided caudal epidural injection. The primary outcome was the change in the Oswestry Disability Index (ODI) at 3 weeks. Secondary outcomes included leg pain and low back pain assessed by visual analogue scale (VAS), health-related quality of life (SF-36), need for repeat epidural injection, and need for lumbar surgery. Clinical assessments were performed at 3 weeks, 3 months, and 6 months.

Results​

A total of 106 patients were randomized, with 53 participants assigned to each treatment group. The primary endpoint was not met, as the improvement in ODI at 3 weeks did not differ significantly between groups (mean change: −9.5 ± 4.4 in the DEXA group versus −13.8 ± 4.4 in the PLACEBO group; p = 0.18). No significant differences were observed for any relevant secondary outcome at any follow-up time point. During the 6-month follow-up, 34 patients in the DEXA group and 30 patients in the PLACEBO group underwent a second, non-blinded injection of dexamethasone (ns). Lumbar surgery was performed in 10 patients in the DEXA group and nine patients in the PLACEBO group (ns). Injection-related adverse events were mild and transient but occurred more frequently in the DEXA group.

Conclusions​

Caudal injection of soluble dexamethasone conferred no clinical benefit over saline placebo in patients with acute sciatica.

Significance Statement​

Epidural injections are widely used worldwide for the treatment of resistant sciatica and have been extensively studied in multiple meta-analyses. However, their clinical value remains debated due to the limited methodological quality of most available studies. We conducted a methodologically rigorous randomized, placebo-controlled trial, which yielded negative results. These findings question the efficacy of caudal epidural injection of a non-particulate corticosteroid administered via a remote (sacrococcygeal) approach for disc-related sciatica.

https://doi.org/10.1002/ejp.70373

This trash came to me from Doximity.
Too many flaws to be useful.
Technique not standard of care (US caudal)
Dose not standard of care (16mg dex)
Volume not standard of care (20ml)
Time frame measured: 3 week, 3 mo, 6 mo poorly chosen. If ESI lasts 8 weeks, Would rather see 1 week, 3 week, 6 week, 9 week, 12 week.
Measures: ODI, VAS, SF36, repeat ESI or surgery (poor choice as depends on doc and not patient)
Failed to recognize improvement in both groups on primary endpoint. MCID 10-15 for spine is fair (6-17 per all literature) and no statistical significance between groups meaning p>.05 so a conclusion cannot be drawn and a larger n is needed.

Title is therefore a lie and disingenuous. Anyone care to deep dive into the institution or authors to see if nefarious government funding exists....

 

[MitchLevi]

20cc of injectate and it is US guided? Not gonna work, study proves nothing? Dex in a caudal is doomed to fail, it's a terrible choice of steroid for an ESI.

The only role IMO of dex for an ESI is with a TFESI and low overall injectate volume so the concentration is high. It simply does not work as well.

Also, caudal is really only helpful for L5-S1 pathology IMO.

 

[willabeast]

Using Dex in a caudal for sciatica has now been proven ineffective. I think it is a worthwhile study. I always thought Dex was way less efficacious than Kenalog and this study confirms that impression. So anyone using Dex for caudals needs to cease. Hopefully they will publish another study with a different steroid.

 

[MitchLevi]

Need a better definition for the pathology because the term herniation is thrown around haphazardly by anyone and everyone. What level is the herniation? Is it L2-3 or L5-S1?

Caudals are good for isthmic spondy at L5-S1 with severe stenosis, post laminectomy with lumbosacral fusions too. I believe you should always use particulate for that procedure because it is simply better. When you mix 8-9cc of injectate together and 1cc of that is 10mg of dex, you've just put a watery slurry of nothing in the epidural space and should not expect much improvement from your patient.

 

[Orin]

When you mix 8-9cc of injectate together and 1cc of that is 10mg of dex, you've just put a watery slurry of nothing in the epidural space and should not expect much improvement from your patient.

I think you're arguing that it would be no different than saline, which is what the study shows

It's a European study so I don't know what the French normally do, but 20 mL should hydrodissect the space so yes, vs an active control, dexamethasone may provide limited extra benefit but there still is some improvement over baseline.

 

[bedrock]

Most important point here is that Dex does not work as well as particulate steroid.

So all the docs using dex instead of depo for caudals or lumbar ILESI, because dex is $4 cheaper than depo should be ashamed of themselves and use an actually effective steroid, something that you would want your mom to receive if she needs an ESI.

 

[lobelsteve]

Most important point here is that Dex does not work as well as particulate steroid.

So all the docs using dex instead of depo for caudals or lumbar ILESI, because dex is $4 cheaper than depo should be ashamed of themselves and use an actually effective steroid, something that you would want your mom to receive if she needs an ESI.

You must have read the wrong thread. This one was a poorly designed study on us guided high volume saline vs high volume saline with 4x normal dose of dex. And it showed both worked the same to reduce ODI at 3 weeks.

I posted this because the title is a lie and misleading. You went to your baseline of “I hate dex”
No one should advocate dex for anything other than tfesi.

 

[bedrock]

You must have read the wrong thread. This one was a poorly designed study on us guided high volume saline vs high volume saline with 4x normal dose of dex. And it showed both worked the same to reduce ODI at 3 weeks.

I posted this because the title is a lie and misleading. You went to your baseline of “I hate dex”
No one should advocate dex for anything other than tfesi.

I agree with your last sentence.

Something I find upsetting is that many pain and many ortho practices have switched to all dex for ILESI, caudals, and peripheral joint injections.
Pain groups use it because dex is dirt cheap. Ortho uses it because patients fail peripheral joint injections so the patients agree to surgery.

 

[lobelsteve]

I agree with your last sentence.

Something I find upsetting is that many pain and many ortho practices have switched to all dex for ILESI, caudals, and peripheral joint injections.
Pain groups use it because dex is dirt cheap. Ortho uses it because patients fail peripheral joint injections so the patients agree to surgery.

If I wanted more stim I would use dex all the time as well.

 

[Ducttape]

Using Dex in a caudal for sciatica has now been proven ineffective. I think it is a worthwhile study. I always thought Dex was way less efficacious than Kenalog and this study confirms that impression. So anyone using Dex for caudals needs to cease. Hopefully they will publish another study with a different steroid.

i think that is being a little provocative if based on this study alone; ultrasound guidance is still not considered standard of care for epidural injections here fluoro seems to still be considered the "widely accepted standard" in France (from CoPilot search).

 

[bedrock]

If I wanted more stim I would use dex all the time as well.

We agree. 👍

 

[Ferrismonk]

ive. I think it is a worthwhile study. I always thought Dex was way less efficacious than Kenalog and this study confirms that impression. So anyone using Dex for caudals needs to cease. Hopefully they will publi

Most important point here is that Dex does not work as well as particulate steroid.

So all the docs using dex instead of depo for caudals or lumbar ILESI, because dex is $4 cheaper than depo should be ashamed of themselves and use an actually effective steroid, something that you would want your mom to receive if she needs an ESI.

I have not seen any literature that Dex is less effective for any ESI. I have only seen it's non-inferior and arguably safer. Guidance I've seen suggests Dex should be steroid of choice for ESI. Care you point me to some better literature?


Also, this "study" doesn't prove anything. We rarely even bolus 20cc in a lumbar epidural to get a woman ready for a c-section where the goal is to be numb from T4 down. If you washout the entire epidural space from all irritants, it's going to feel better.

 

[bedrock]

I have not seen any literature that Dex is less effective for any ESI. I have only seen it's non-inferior and arguably safer. Guidance I've seen suggests Dex should be steroid of choice for ESI. Care you point me to some better literature?


Also, this "study" doesn't prove anything. We rarely even bolus 20cc in a lumbar epidural to get a woman ready for a c-section where the goal is to be numb from T4 down. If you washout the entire epidural space from all irritants, it's going to feel better.

Not everything in medicine has a level one study. But please show me a level one or two study demonstrating that dex is better than particulate steroid. I’m waiting.

Meanwhile, if you haven’t noticed by now that particulate steroid lasts longer than dex in many (not all situations), then its not worth having the discussion with you.

 

[lobelsteve]

I have not seen any literature that Dex is less effective for any ESI. I have only seen it's non-inferior and arguably safer. Guidance I've seen suggests Dex should be steroid of choice for ESI. Care you point me to some better literature?


Also, this "study" doesn't prove anything. We rarely even bolus 20cc in a lumbar epidural to get a woman ready for a c-section where the goal is to be numb from T4 down. If you washout the entire epidural space from all irritants, it's going to feel better.

TFESI study showing Dex requires more injections than particulate. 1.7:1
THere are studies showing superiority of particulate over dex and studies showing non-inferiority.
Safety profile: 1 in a million to paralyze vs 1 ever (reported) Safety of dexamethasone in transforaminal epidural steroid injections: A case of temporary paraplegia caused by injection of lidocaine and dexamethasone into a lumbar radiculomedullary artery, with no neurologic sequelae - PMC.

 

[hyperalgesia]

I have not seen any literature that Dex is less effective for any ESI. I have only seen it's non-inferior and arguably safer. Guidance I've seen suggests Dex should be steroid of choice for ESI. Care you point me to some better literature?


Also, this "study" doesn't prove anything. We rarely even bolus 20cc in a lumbar epidural to get a woman ready for a c-section where the goal is to be numb from T4 down. If you washout the entire epidural space from all irritants, it's going to feel better.

Dex works great for my patients. I offer depo when the response is suboptimal. I have a few who prefer depo. I also have a few who feel dex is superior.

I have zero incentive to choose one over the other.

It's interesting to see how emotional people get about dex. Not typically seen in medicine.