Sub-Perception and Supra-Perception Spinal Cord Stimulation in Chronic Pain Syndrome: A Randomized, Semi-Double-Blind, Crossover, Placebo-Controlled Trial
Autor: | Paweł Sokal, Marcin Rudaś, Marcin Rusinek, Agnieszka Malukiewicz, Cezary Guzowski, Joanna Murawska, Dariusz Paczkowski, Mateusz Krakowiak, Sara Kierońska |
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Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: |
genetic structures
Visual analogue scale spinal cord stimulation Placebo-controlled study lcsh:Medicine Stimulation Placebo Article 03 medical and health sciences placebo control 0302 clinical medicine 030202 anesthesiology Medicine business.industry lcsh:R Chronic pain complex regional pain syndrome General Medicine medicine.disease Crossover study Trunk cross-over trial Complex regional pain syndrome Anesthesia failed back surgery syndrome business 030217 neurology & neurosurgery |
Zdroj: | Journal of Clinical Medicine Volume 9 Issue 9 Journal of Clinical Medicine, Vol 9, Iss 2810, p 2810 (2020) |
ISSN: | 2077-0383 |
DOI: | 10.3390/jcm9092810 |
Popis: | 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. |
Databáze: | OpenAIRE |
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