VELOCITY
Research type
Research Study
Full title
A Multi-Center Controlled Study to characterize the real-world outcomes of High Rate Spinal Cord Stimulation therapy using Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System
IRAS ID
199075
Contact name
Vivek Mehta
Contact email
Sponsor organisation
Boston Scientific
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 10 months, 31 days
Research summary
The purpose of this prospective, multi-center, single-arm study is to characterize the real-world outcomes of high rate spinal cord stimulation therapy as an aid in the management of chronic intractable pain of the trunk, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain using the commercially available Boston Scientific (BSC) PRECISION Spinal Cord Stimulator System with MultiWave Technology. \nUp to 60 patients in up to 10 sites in Europe will be enrolled and followed up to 12 months after device activation. Eligible subjects, following written consent will receive the commercial stimulation device programmed at 10KHz as part of their standard of care. Study candidates will be drawn from the population of patients resident in pain management or surgical medical practices. \nPain scores, medication intake, need for care, disability and quality of life questionnaires will collect the necessary data for the study endpoints.\nThe primary endpoint is the low back pain responder rate at 3 months post-activation as compared with Baseline. A responder is defined as ≥30% low back pain reduction from Baseline without change in opioids. Secondary endpoints are: * Change in average low back pain from Baseline to 3 months post-Activation (NRS); * Change in average leg pain from Baseline to 3 months post-Activation (NRS); * Percent pain relief of low back pain at 3 months post-Activation (PPR); * Percent pain relief of leg pain at 3 months post-Activation (PPR); * Change in low back pain with activity from Baseline to 3 months post-Activation (NRS); * Change in leg pain with activity from Baseline to 3 months post-Activation (NRS); * Patient global impression of change at 3 months post-Activation (PGI-C); * Change in disability from Baseline to 3 months post-Activation (ODI v2.1a); * Change in quality of life from Baseline to 3 months post-Activation (SF-36v2).\nIn the period between the Baseline visit and 3 months visit (primary endpoint visit) patients will be requested not to change their pain medication intake (pain medication lock). Completion of the questionnaires will continue up to 12 months after device activation.\n\nThis study requires questionnaires completion and a pain medication lock for three months from participating patients, who will receive, as part of their standard of care, a commercial spinal cord stimulation device at programmed at high frequency, to record the effects of the device for the treatment of chronic low back pain. Effects being studied are: Pain scores, medication intake, need for care, disability and quality of life.
REC name
London - Fulham Research Ethics Committee
REC reference
16/LO/0304
Date of REC Opinion
1 Mar 2016
REC opinion
Further Information Favourable Opinion