Clinical outcomes using a fast-acting sub-perception therapy for chronic pain: A european observational study
Simon Bayerl (Berlin), Jose Paz-Solis (Madrid / ES), Georgios Matis (Köln), Jan Willem Kallewaard (Arnhem / NL), Philippe Rigoard (Poitiers / FR), Jan Vesper (Düsseldorf), Jose Emilio Llopis (Valencia / ES), Goldberg Edward (Valencia, MA / US)
Traditional Spinal Cord Stimulation (SCS) modalities that achieve sub-perception analgesia require patients to often wait hours or even days until pain relief is fully realized. The objective of the study was to assess the magnitude and quality of pain relief in patients using a new sub-threshold-based SCS modality called Fast-Acting Sub-Perception Therapy (FAST) for chronic pain in a European-based, multicenter, observational study.
This is an international, multicenter, observational case-series of patients permanently implanted with a FAST enabled SCS system (Boston Scientific, Marlborough, MA USA) to treat chronic pain as part of an ongoing assessment of real-world outcomes of SCS for chronic pain based on retrospective chart review (Clinicaltrials.gov identifier: NCT01550575). All analyzed patients are programmed using novel FAST (i.e., biphasic-symmetric waveform at 90 Hz; pulse width: 160- 260 µs). To minimize potential bias, data collection from patients is being performed directly by clinical site personnel without any sponsor involvement. Demographic information, pain location, surgical history, medical history are being collected for all subjects. In addition, Numeric Rating Scale (NRS) scores and Percent Pain relief (PPR) are being collected as part of the chart review. Mean, median, and standard deviations will be calculated for demographic data and NRS scores.
To date, 143 patients have been assessed out to a mean follow-up duration of 531±450 days. Baseline mean NRS pain score inthis current cohort was determined to be 7.9±1.2.
A 5.1 ± 2.4-point improvement (p<0.0001) in overall pain was reported at mean last follow-up (n=143). A 5.0-point (n=76, p<0.0001) and 5.8-point (n=40, p<0.0001) decrease in overall NRS pain score was noted in patients who reached their 1-year and 2-year visits respectively, compared to baseline. Assessment of quality of life (EQ-5D-5L) and Disability (Oswestry Disability Index) demonstrated substantial improvement compared to baseline measurements. Based on patients who reported PPR at last follow-up, responder rate (PPR>50%) was 88.8% (n=79/89).
A methodology that allows for near immediate pain relief following activation of neurostimulative treatment therefore represents an advancement that may further improve the outcomes and experience of patients who desire to use sub-perception-based SCS for relief of their chronic pain.
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