Open AccessEffects of Rate on Analgesia in Kilohertz Frequency Spinal Cord Stimulation: Results of the PROCO Randomized Controlled Trial
Author(s) -
Thomson Simon J.,
Tavakkolizadeh Moein,
LoveJones Sarah,
Patel Nikunj K.,
Gu Jianwen Wendy,
Bains Amarpreet,
Doan Que,
Moffitt Michael
Publication year - 2018
Publication title -
neuromodulation: technology at the neural interface
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.296
H-Index - 60
eISSN - 1525-1403
pISSN - 1094-7159
DOI - 10.1111/ner.12746
Subject(s) - medicine , randomized controlled trial , anesthesia , crossover study , transcutaneous electrical nerve stimulation , randomization , visual analogue scale , pulse (music) , stimulation , surgery , placebo , voltage , physics , quantum mechanics , alternative medicine , pathology
Objective The PROCO RCT is a multicenter, double‐blind, crossover, randomized controlled trial (RCT) that investigated the effects of rate on analgesia in kilohertz frequency (1–10 kHz) spinal cord stimulation (SCS). Materials and Methods Patients were implanted with SCS systems and underwent an eight‐week search to identify the best location (“sweet spot”) of stimulation at 10 kHz within the searched region (T8–T11). An electronic diary (e‐diary) prompted patients for pain scores three times per day. Patients who responded to 10 kHz per e‐diary numeric rating scale (ED‐NRS) pain scores proceeded to double‐blind rate randomization. Patients received 1, 4, 7, and 10 kHz SCS at the same sweet spot found for 10 kHz in randomized order (four weeks at each frequency). For each frequency, pulse width and amplitude were titrated to optimize therapy. Results All frequencies provided equivalent pain relief as measured by ED‐NRS ( p ≤ 0.002). However, mean charge per second differed across frequencies, with 1 kHz SCS requiring 60–70% less charge than higher frequencies ( p ≤ 0.0002). Conclusions The PROCO RCT provides Level I evidence for equivalent pain relief from 1 to 10 kHz with appropriate titration of pulse width and amplitude. 1 kHz required significantly less charge than higher frequencies.