Neuromodulation : journal of the International Neuromodulation Society
-
Randomized Controlled Trial Multicenter Study
Success Using Neuromodulation With BURST (SUNBURST) Study: Results From a Prospective, Randomized Controlled Trial Using a Novel Burst Waveform.
The purpose of the multicenter, randomized, unblinded, crossover Success Using Neuromodulation with BURST (SUNBURST) study was to determine the safety and efficacy of a device delivering both traditional tonic stimulation and burst stimulation to patients with chronic pain of the trunk and/or limbs. ⋯ 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.
-
Randomized Controlled Trial Multicenter Study
Effects of Rate on Analgesia in Kilohertz Frequency Spinal Cord Stimulation: Results of the PROCO Randomized Controlled Trial.
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). ⋯ 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.
-
Spinal Cord Stimulation (SCS) is an effective treatment for chronic pain. How often pain remission follows SCS has not been evaluated. This is a retrospective analysis of patients who underwent an implantation of spinal cord stimulators for various chronic pain conditions. The objective of the study was to elucidate characteristics and features of patients with pain relief greater than 80% after one year of treatment. ⋯ Our study demonstrates a remission rate of 22% with SCS at one-year follow with a total of 19.8% of our total patient cohort having an NRS of 0. Greater decreases in PCS and ODI correlate with remission. Further, pre-operative disability and opioid use correlate with lower likelihood of remission.
-
In our previous study, anti-inflammatory IL-10 serum levels were significantly elevated after burst spinal cord stimulation (SCS) in back pain patients and correlated with pain intensity. This current study extended cytokine analysis including metabolic-associated adipokine/cytokine serum assessment in chronic back pain patients with co-existing metabolic disorders such as diabetes, hypertension, and cardiovascular diseases. ⋯ This study determined serum changes of metabolic-associated cytokines/adipokines in non-obese chronic back pain patients responsive to burst SCS suggesting that neuroinflammation assessment may consider pain-associated mood, cognition, sleep, and metabolic state.
-
Observational Study
Is the Self-Reporting of Failed Back Surgery Syndrome Patients Treated With Spinal Cord Stimulation in Line With Objective Measurements?
To understand the subjective pain experience of patients, healthcare providers rely heavily on self-reporting. However, to quantify this unique pain experience, objective parameters are not yet available in daily clinical practice. With regard to patients with failed back surgery syndrome (FBSS) treated with spinal cord stimulation (SCS), pain therapists may recover the individual functional information about the patient's posture from the implantable pulse generator (IPG) of the stimulator. The aim of this study is to investigate whether subjective self-reporting is in correlation with the functional capacities of a patient. ⋯ This study demonstrated that self-reporting questionnaires do not correlate with the findings of objective measurements. Therefore, we recommend using both subjective and objective parameters when determining treatment options for FBSS patients.