Clinicals

Question 1

LAMINA study

Answer 1

• Pain Med. 2017
• SCS with Lumina 3D vs. traditional SCS with Precicion plus

STUDY DESIGN AND METHODS:

• multicenter, open-label observational study with an observational arm and retrospective analysis of a matched cohort.

RESULTS:

• 213 patients
• trial-to-implant ratio 86%.
• 24 months
• pain intensity decreased significantly from baseline (ΔNRS = 4.2, N = 169, P  < 0.0001) and even more in in the severe pain subgroup (ΔNRS = 5.3, N = 91, P  < 0.0001).
• Axial low back pain also decreased significantly from baseline to 24 months (ΔNRS = 4.1, N = 70, P  < 0.0001, on the overall cohort and ΔNRS = 5.6, N = 38, on the severe subgroup).
• Matched cohort comparison with 213 patients treated with traditional SCS at the same centers showed overall pain responder rates of 51% (traditional SCS) and 74% (neural targeting SCS) and axial low back pain responder rates of 41% and 71% in the traditional SCS and neural targeting SCS cohorts,
• complications occurred in a total of 33 of the 213 patients, with a 1.6% lead replacement rate and a 1.6% explant rate.

CONCLUSIONS:

3D neural targeting SCS and its associated hardware flexibility provide effective treatment for both chronic leg and chronic axial low back pain that is significantly superior to traditional SCS.

Question 2

PROCO RCT

Answer 2

CONCLUSIONS:

The PROCO RCT showed no clinical difference in pain relief using frequencies from 1–10kHz,

proper neural dosing (amplitude, pulswidh) is required to optimise frequencies.

1kHz provides excellent pain relief using significantly less energy,”

• (p=0.00002)
• multicentre, double-blind, crossover study.
• paraesthesia coverage ≥80% of pain areas—
• E diary
• Only 10kHz responders (minimum of >30% pain reduction as per e-diary) continued in the study.
• wash out period
• 20 pt
• to secondary endpoints
  
  • quality-of-life measurements: no statistical difference between frequencies (p>0.8).

“Achieving pain relief requires delivering the right waveform to the right target, very careful finding of this bipole to achieve best pain relief and then optimisation of the stimulation by amplitude and pulse width at each frequency. Frequency cannot be looked at in isolation—the different frequencies required different pulse width and amplitude combinations,”

Question 3

Is there a clinical difference in pain relief using spinal cord stimulation frequencies from 1kHz to 10kHz? Previous studies showed that SCS can be effective at 1kHz and 10kHz?

Answer 3

No, PROCO

Question 4

E-diary in PROCO

Answer 4

The e-diary was in the form of a watch strap worn by the patients for nine months that would prompt them three times a day to enter a pain score from three sites—the back, legs and overall pain; it also confirmed that their opioid dose had remained stable.

Question 5

why e diary better than paper version

Answer 5

• better complience
• real time data (vs etrospective)

Question 6

What implications could the results of the PROCO study have on current clinical practice?

Answer 6

There is no doubt that kHz frequency stimulation of the spinal cord can achieve pain relief. There is no superiority of 10kHz stimulation over 1khz stimulation provided that there is targeting and optimal neural dosing of the stimulation. Patients can enjoy the benefits of both paraesthesia based SCS and kHz frequency SCS from the same device.

Question 7

Senza study

Answer 7

long-term superiority of HF10 therapy compared with traditional SCS in treating both back and leg pain. The advantages of HF10 therapy are anticipated to impact the management of chronic pain patients substantially.

Question 8

Senza 24 mnths results

Answer 8

10KHZ vs traditional SCS:

3 months backpain: 84.5% vs. 43.8

3 monts leg 83.1% vs. 55.5% f

P < .001 for both back and leg pain comparisons, non-inferiority and superiority).

24 months,

bckpain: 76.5% vs 49.3%; P < .001 for non-inferiority and superiority;

leg pain: 72.9% vs 49.3%; 2 P < .001 for non-inferiority and P = .003 for superiority).

Question 9

SUNBURST

Answer 9

:The SUNBURST study demonstrated that burst spinal cord stimulation is safe and effective. Burst stimulation was not only noninferior but also superior to tonic stimulation for the treatment of chronic pain. A multimodal stimulation device has advantages.

Question 10

All relevant studies

Answer 10

SUNBURST: burst vs tonic stim

• preference (70%)

SENZA: 10khz vs conventional SCS

LUMINA Lumina 3D vs prec. plus

PROCO1-10khz