Cochrane review concludes SCS is ineffective for chronic low back pain

[Ferrismonk]

Nobody posts failures on LinkedIn…could be onto something my friend. Would definitely change the perspective. All the younger docs like myself see is KOL posting about sucessful SCS, reactiv8 (which works as long as you screen with the prone instability test) , this that and the other, but what we need to see is real life and learn from those who have been in the trenches, not eating scallops

What do you have against scallops?

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[Tboned]

What do you have against scallops?

Lol I love scallops, they’re delicious

 

[SC Tian]

 

[Ducttape]

add on study, open phase, so not really a study - an observation that of course confirmed their prexisting impression.

was compared to baseline and not blinded.

rather worthless.

the article. even when you look at the specific reference, there is no data that is posted. it may be available for purchase but i did not do so. if anyone does, please review.

thanks.

Long-Term Effect of Peripheral Nerve Field Stimulation as Add-On Therapy to Spinal Cord Stimulation to Treat Low Back Pain in Failed Back Surgery Syndrome Patients: A 12-Month Follow-Up of a Randomized Controlled Study

Different approaches in neuromodulation have been used to treat chronic low back pain in failed back surgery syndrome (FBSS) patients. We previously r…

www.sciencedirect.com

 

[SC Tian]

Pain Ther 2021 Dec;10(2):1451-1465.
doi: 10.1007/s40122-021-00307-3. Epub 2021 Sep 3.

Restorative Neurostimulation for Chronic Mechanical Low Back Pain: Results from a Prospective Multi-centre Longitudinal Cohort​

Simon Thomson 1, Rajiv Chawla 2, Sarah Love-Jones 3, Manohar Sharma 2, Girish Vajramani 4, Adam Williams 3, Sam Eldabe 5; ReActiv8 PMCF Investigators
Collaborators, Affiliations expand

• PMID: 34478115
• PMCID: PMC8586272
• DOI: 10.1007/s40122-021-00307-3

Free PMC article

Abstract​

Introduction: Low back pain impacts most people throughout the course of their lives and contributes significantly to the global burden of disease. In some patients, symptoms resolve with little intervention, while others are amenable to surgical intervention, some cases are intractable to current care paradigms. Restorative neurostimulation is an emerging therapy for chronic mechanical low back pain.
Methods: We conducted a prospective post-market follow-up of 42 patients treated for longstanding chronic mechanical low back pain with restorative neurostimulation. Patients were followed up at 45, 90, and 180 days and 1 and 2 years following activation of the device. Pain, disability, and health-related quality of life were recorded.
Results: Among the 37 patients completing 2-year follow-up, numerical rating scale (NRS) pain scores improved from 7.0 ± 0.2 to 3.5 ± 0.3 (p < 0.001), Oswestry Disability Index (ODI) scores improved from 46.2 ± 2.2 to 29.2 ± 3.1 (p < 0.001), and health-related quality of life (measured by the EuroQol 5-Dimension 5-Level questionnaire-EQ-5D-5L) improved from 0.426 ± 0.035 to 0.675 ± 0.030 (p < 0.001). Additionally, 57% of patients experienced a greater than 50% reduction in pain, and 51% of patients benefited by a greater than 15-point reduction in ODI, both substantial improvements.
Conclusion: This real-world sample of patients shows that restorative neurostimulation can provide substantial and durable benefit to a cohort of patients that have traditionally had few reliable treatment options. Our findings support the continued used of this therapy in well-selected patients.
Trial registration: ClinicalTrials.gov Identifier: NCT01985230.
Keywords: Mechanical chronic low back pain; Multifidus; Real-world evidence; Restorative neurostimulation.

 

[SC Tian]

Anyone would comment on this? Thanks

 

[lobelsteve]

Anyone would comment on this? Thanks

Complete nonsense. It is a post marketing survey. 37/42 patients at 2 year mark. Who were these 42? How many were screened to be these 42? 5 sites over x years to recruit. Nonconsecutive, no randomization. Mean age of 47 and only 17% worked full time.

Methods​

Study Design​

This post-market clinical follow-up (PMCF) study is an open label 5-year prospective follow-up of patients with intractable CLBP treated with restorative neurostimulation of the L2 medial branch of the dorsal ramus at five sites in the United Kingdom. The data presented here are the 2-year patient-reported outcomes collected across all five UK sites (ClinicalTrials.gov Identifier: NCT01985230). Any serious adverse events, whether related or not, and related adverse events were classified by the treating physician. These events were categorised as ‘device-related’, ‘procedure-related’, ‘stimulation-related’, or ‘unrelated’, and were tracked longitudinally through to resolution. Patients were implanted with a ReActiv8® device (Mainstay Medical, Dublin, Ireland) according to the manufacturer’s instructions.
The study protocol was reviewed and approved by a central ethics committee (NHS Health Research Authority North East—York Research Ethics Committee IRA’s project ID number 149412) as is required in the UK, and the protocol was followed in accordance with the Helsinki Declaration of 1964 and its later amendments. All subjects provided written informed consent to participate in the study.

Patient Selection​

Consenting patients suitable for treatment with restorative neurostimulation therapy were recruited from five sites across the UK and included in the PMCF. As this cohort was intended to represent restorative neurostimulation in general clinical practice, little formal guidance was given in the way of selection criteria beyond the instructions for use and indications for the CE Mark. Effectively, patients were eligible if they were adults with a history of predominantly mechanical CLBP for longer than 90 days that was refractory to physiotherapy and medication, though in practice the patient history of CLBP was considerably longer. Physicians were trained in physical tests to establish the presence of mechanical low back pain with multifidus dysfunction such as the prone instability test [20] to include as part of the clinical work up, though the results of these individual tests were not additional inclusion or exclusion criteria. Patients were not indicated for implantation if they had a clear indication for surgery, or another clinical condition that the treating physician deemed could interfere with delivery of the therapy or assessment of pain relief. Patients were assessed at baseline by a chronic pain, musculoskeletal, or neuromodulation management multidisciplinary team (MDT). Psychological impact was assessed using both MDT assessment and the Depression, Anxiety and Stress Scale (DASS) [21], where a threshold of greater than 10–13 on the depression subscale is indicative of mild depression, and 14+ moderate to severe depression. Depression was not an exclusion criterion in this cohort. Thus the patients enrolled into this study presented with chronic mechanical low back pain with multifidus dysfunction as identified by their treating physician using physical assessment and/or magnetic resonance imaging (MRI) in order to be consistent with the instructions for use of the device.

 

[Ducttape]

no control/placebo group. only treated patients. this will of course bias the results. no real comparator, so of course it looks good as the researchers ask how they are doing.

Also, funded by Reactiv8.

in addition, hard to interpret data when patients are excluded from data as they are explanted. of the 42 patients, 5 got explanted due to lack of efficacy. 9.5% of group were explanted due to lack of efficacy and they imputed the benefit from these people statistically because they were not followed up.... which sounds iffy at best.

28% complication rate - though they state that the vast majority was from over stimulation that was easily resolved with changing stim program.

 

[lobelsteve]

no control/placebo group. only treated patients. this will of course bias the results. no real comparator, so of course it looks good as the researchers ask how they are doing.

Also, funded by Reactiv8.

in addition, hard to interpret data when patients are excluded from data as they are explanted. of the 42 patients, 5 got explanted due to lack of efficacy. 9.5% of group were explanted due to lack of efficacy and they imputed the benefit from these people statistically because they were not followed up.... which sounds iffy at best.

28% complication rate - though they state that the vast majority was from over stimulation that was easily resolved with changing stim program.

Yup. Baseline observation carried forward was what should have been used in the statistical analysis. (BOCF)

 

[SC Tian]

I am laughing at the word “restorative”, medial branch stim is better than Radiofrequency abaltion? do not believe it.

 

[lobelsteve]

This is exactly what bothers me about this entire charade. What is "low back pain" exactly, and why would SCS reliably treat it?

This is the same situation as DRG stimulation for post TKA pain, which is virtually always mechanical in nature. I work in a large ortho group and we're doing huge numbers of knees. I've seen a great deal of post TKA pain and not once have I seen one with anything close to resembling CRPS. I think Abbott teaches it as causalgia in their DRG by the way. Not quite sure why they call it that or if they still do. Last I checked, the American Civil War was a long time ago and that term isn't currently used.

...I just checked the Abbott website. They're using CRPS on the site.

Geriatric spine pain is largely mechanical in my corner of the world, and generally responds favorably to RFA.


Like I said, I use Nevro. I am happy to hear you're finding success in 90% of your implants. Did you get that number from the charts Nevro emails you, or did you get that number from your own data collecting after speaking to your patients?

I get those charts they email but it just doesn't seem to align with the human beings sitting in front of me on a random clinic visit on Tuesday.

BTW - Yesterday 810 AM I saw a FBSS with radic pt with a Nevro implant who is doing great with his buttock and leg pain, modestly beneficial with his back pain and zero relief of his DPN with A1C < 9.

He's a success story, but his success is directly countered by the Nevro implant I removed yesterday at 7AM (before clinic). A woman with classic FBSS and chronic radic with mild LBP.

I definitely wouldn't claim 9/10 pts are significantly improved, and I'm extremely restrictive in who I implant.

I should add, if they're going to start charging more money for implants bc of their new AI programming I'm probably going to just stop using them TBH.

Good morning everyone! I spoke with XXX for her perm 7 today. She is reporting 95% overall relief for what her SCS is targeted to treat. She is reporting a new pain to left side a heaviness. When verifying her settings she was on G3/P4/2L. Moved her back to G2/P1/4L where she was on our last call. Thanks you

Hi Team. I left a voicemail for perm 7. I spoke with YYY Monday and she was reporting 95% on G2/P1/3L. Thanks!

I get a lot of these feedback emails.

 

[MitchLevi]

I get a lot of these feedback emails.

That's bc you use the special leads.

 

[lobelsteve]

That's bc you use the special leads.

lick em and stick em

 

[Orin]

It's very precise verbiage meant to drive you to think it's doing more than it is. I feel this changed with SENZA as companies became better at asking the questions for which they had positive answers.

"95% overall relief for what her SCS is targeted to treat"

overall relief so you think it's a holistic thing
area it is "targeted to treat" so the patient answers just for the pain that it's helping for, but not that other pain that it isn't helping for

It's not quite a guided question/answer session, but it's steering them towards the answer the vendor wants
It'll be interesting when they start doing more functional or objective metrics to see what happens to this transparency/reporting

 

[Ronin1]

Just saw someone that one of our neurosurgeons implanted with reactive8. 3 months in no change. Wants pain meds lol. He should have just had a RFA.

 

[lobelsteve]

Just saw someone that one of our neurosurgeons implanted with reactive8. 3 months in no change. Wants pain meds lol. He should have just had a RFA.

RF the MBB through the leads.
Tell NS to Rx since he is a pain doc now.

 

[MitchLevi]

Neurosurgeons doing SIJ fusions is great too

 

[gaseous_clay]

Pay those bills bro!

Porsche ain't gonna buy itself.

"Sir...You will hurt indefinitely on one level or another. You're lit up with arthritis and there's no fixing this."

WTF can't anyone say that!?!? It isn't your fault that pt got older.

There are spine surgeons who have this same mentality too. Fusing for axial low back pain with minimal stenosis seen on MRI and no myelopathy on exam. Or those who do their own “epidurals” knowing full well documenting failure of these sham injections will allow them rationalize a fusion to the insurance carriers.

 

[redchyvak]

Just saw someone that one of our neurosurgeons implanted with reactive8. 3 months in no change. Wants pain meds lol. He should have just had a RFA.

The Sprint rep came in today talking about indications for their product; one of them was that they've had a lot of success with medial branch "regeneration." Pull it out and switch to them!