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. 2020 Aug 31;9(9):2810.
doi: 10.3390/jcm9092810.

Sub-Perception and Supra-Perception Spinal Cord Stimulation in Chronic Pain Syndrome: A Randomized, Semi-Double-Blind, Crossover, Placebo-Controlled Trial

Paweł Sokal  1   2 , Agnieszka Malukiewicz  1 , Sara Kierońska  1 , Joanna Murawska  3 , Cezary Guzowski  3 , Marcin Rudaś  1 , Dariusz Paczkowski  1 , Marcin Rusinek  1 , Mateusz Krakowiak  1
Affiliations

Sub-Perception and Supra-Perception Spinal Cord Stimulation in Chronic Pain Syndrome: A Randomized, Semi-Double-Blind, Crossover, Placebo-Controlled Trial

Paweł Sokal et al. J Clin Med. .

Abstract

Background: The introduction of modern sub-perception modalities has improved the efficacy of spinal cord stimulation (SCS) in refractory pain syndromes of the trunk and lower limbs. The objective of this study was to evaluate the effectiveness of low and high frequency SCS among patients with chronic pain.

Material and methods: A randomised, semi-double-blind, placebo controlled, four period (4 × 2 weeks) crossover trial was conducted from August 2018 to January 2020. Eighteen patients with SCS due to failed back surgery syndrome and/or complex regional pain syndrome were randomised to four treatment arms without washout periods: (1) low frequency (40-60 Hz), (2) 1 kHz, (3) clustered tonic, and (4) sham SCS (i.e., placebo). The primary outcome was pain scores measured by visual analogue scale (VAS) preoperatively and during subsequent treatment arms.

Results: Pain scores (VAS) reported during the preoperative period was M (SD) = 8.13 (0.99). There was a 50% reduction in pain reported in the low frequency tonic treatment group (M (SD) = 4.18 (1.76)), a 37% reduction in the 1 kHz treatment group (M (SD) = 5.17 (1.4)), a 34% reduction in the clustered tonic settings group (M (SD) = 5.27 (1.33)), and a 34% reduction in the sham stimulation group (M (SD) = 5.42 (1.22)). The reduction in pain from the preoperative period to the treatment period was significant in each treatment group (p < 0.001). Overall, these reductions were of comparable magnitude between treatments. However, the modality most preferred by patients was low frequency (55% or 10 patients).

Conclusions: The pain-relieving effects of SCS reached significance and were comparable across all modes of stimulation including sham. Sub-perception stimulation was not superior to supra-perception. SCS was characterised by a high degree of placebo effect. No evidence of carryover effect was observed between subsequent treatments. Contemporary neuromodulation procedures should be tailored to the individual preferences of patients.

Keywords: complex regional pain syndrome; cross-over trial; failed back surgery syndrome; placebo control; spinal cord stimulation.

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Conflict of interest statement

Paweł Sokal reports non-financial support from Medtronic and Boston Scientific. Agnieszka Malukiewicz and Marcin Rudaś report non-financial support from Boston Scientfic. Sara Kierońska, Joanna Murawska, Cezary Guzowski, Marcin Rusinek, Dariusz Paczkowski, and Mateusz Krakowiak report no conflicts of interest.

Figures

Figure 1
Figure 1
Consort flowchart.
Figure 2
Figure 2
Average daily visual analogue scale (VAS) scores, separately for each treatment and subject, as a function of treatment day.
Figure 3
Figure 3
Predicted marginal means of mean VAS scores.
Figure 4
Figure 4
Distributions of individual average VAS scores for each treatment type and baseline.
Figure 5
Figure 5
Distributions of total number of medications taken separated by medication and treatment types.
See this image and copyright information in PMC

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