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[drusso]

Stimulator Reduces Pain for Chronic Pain Patients

How to Get Relief from Chronic Pain

CBD Oil, the new medical elixir

Northwest Indiana pain patients say they're unintentional victims of the opioid epidemic

Anderson, 52, used to take 90 milligrams of extended-release morphine. But in the midst of an epidemic of overdose deaths from opioids, her doctor took her off it.

She's on a shorter-acting, lower-strength form of the medication now. She says she can barely function.

She's not an addict, she says. Why can't she get the medicine she needs?

"It's almost to me like taking insulin away from a diabetic," she said. "To have a good, productive life and to have it taken away is like a shot in the gut."

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[Aether2000]

But, what about the double blind randomized trial that found no statistical difference between HF stimulation and sham?
Neuromodulation. 2013 Jul-Aug;16(4):363-9; discussion 369. doi: 10.1111/ner.12027. Epub 2013 Feb 20.
Analgesic efficacy of high-frequency spinal cord stimulation: a randomized double-blind placebo-controlled study.
Perruchoud C1, Eldabe S, Batterham AM, Madzinga G, Brookes M, Durrer A, Rosato M, Bovet N, West S, Bovy M, Rutschmann B, Gulve A, Garner F, Buchser E.
Author information

Abstract
INTRODUCTION:
Spinal cord stimulation is a recognized treatment of chronic neuropathic and vascular pain. Recent data suggest that the use of very high-frequency (HF) stimulation modes does produce analgesia without paresthesia.

AIM OF THE STUDY:
To compare the efficacy of HF stimulation (HF spinal cord stimulation [HFSCS]) and sham stimulation on the patient's global impression of change (PGIC), pain intensity, and quality of life.

PATIENTS AND METHODS:
Forty patients who have achieved stable pain relief with conventional SCS have been recruited. After randomization, HFSCS and sham are initiated in a double-blind randomized two-period-crossover design.

RESULTS:
Complete data were available from 33 patients. The primary outcome was a minimal improvement in the PGIC. The proportion of patients responding under HFSCS was 42.4% (14/33 patients) vs. 30.3% (10/33 patients) in the sham condition. The mean benefit of HF vs. sham was not statistically significant with a proportion of 11.2% in favor of HFSCS (p = 0.30). There was a highly statistically significant "period effect," irrespective of treatment received, with 51.5% of patients (N = 17) improving at visit 3 vs. 21.2% (N = 7) at visit 5 (p = 0.006). The mean pain visual analog scale (VAS) on sham was 4.26 vs. 4.35 on HFSCS (p = 0.82) and the mean EuroQol five-dimensional (EQ-5D) index with HFSCS was 0.480 vs. 0.463 with sham (p = 0.78).

CONCLUSION:
This is the first randomized double-blind study on SCS. HFSCS was equivalent to sham for the primary outcome (improvement of PGIC) as well as for both the secondary outcomes (VAS and EQ-5D index). There was a highly statistically significant "period effect" (p = 0.006) with improved PGIC scores in the first study period regardless of the treatment. The same trend was seen for VAS and EQ-5D. It appears that the effect of HFSCS and sham is equal and only the order in the sequence, not the nature of the treatment, seems to dictate the effect.

 

[No Pain All gain]

That study, and Al-Kaisy’s recent sham-controlled study went up to 5 KHz (perruchoud) and 5882 Hz (Al-Kaisy). So can’t just say kilohertz SCS no better than sham. Biomimetic stim patterns like Burst DR more likely to have non-placebo effect in my opinion. But honestly there are more questions than answers.


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[Aether2000]

The study I quoted noted no statistically significant difference with sham vs HF stimulation. The Al-Kaisy study showed 58% reduction in pain with 5882 kHz (why that number was chosen is curious) and sham showed a 38% reduction in pain. Therefore overall the SCS HF system resulted in a reduction in pain by 2 VAS compared to sham; or in other words, a 20% reduction in pain compared to placebo. Is that clinically significant? Only time will tell and ultimately the most important factor is whether insurers believe this is significant, or prefer to quote the former rather than the latter study results.

 

[painfree23]

How early after surgery do you diagnose “post laminectomy” syndrome in order to start setting them up for stim? 6 months?

 

[No Pain All gain]

The study I quoted noted no statistically significant difference with sham vs HF stimulation. The Al-Kaisy study showed 58% reduction in pain with 5882 kHz (why that number was chosen is curious) and sham showed a 38% reduction in pain. Therefore overall the SCS HF system resulted in a reduction in pain by 2 VAS compared to sham; or in other words, a 20% reduction in pain compared to placebo. Is that clinically significant? Only time will tell and ultimately the most important factor is whether insurers believe this is significant, or prefer to quote the former rather than the latter study results.

These are all very small studies with limited numbers of data points. There are more questions than answers.


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