Publications by authors named "Alexander Hersel"
Background: There is paucity of data from randomized controlled trials supporting the use of peripheral nerve stimulation, a well-established therapy for the treatment of chronic pain. This study was undertaken, in part, to provide randomized controlled trial data in support of patient access to appropriate peripheral nerve stimulation therapy. The COMFORT study is the first large, postmarket, multicenter randomized controlled trials investigating the use of a Food and Drug Administration-cleared micro-implantable pulse generator (IPG) for treating chronic pain via peripheral nerve stimulation therapy.
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- The COMFORT Study aims to assess the safety and effectiveness of Nalu Neurostimulation for treating chronic neuropathic pain compared to standard medical treatment.
- This randomized controlled trial (RCT) will involve multiple centers, focusing on pain in specific areas like the low back, shoulder, knee, or foot/ankle and following participants for 36 months.
- The findings could provide crucial evidence supporting the use of Peripheral Nerve Stimulation (PNS) for chronic pain, as it would be the largest and first Level-I evidence study on this therapy.
Background: We report the results from the first large, postmarket, multicentre, randomised controlled trial (RCT) evaluating peripheral nerve stimulation (PNS) for the treatment of chronic peripheral pain with a micro-implantable pulse generator (micro-IPG).
Methods: Subjects meeting eligibility were randomised (2:1) to either the active arm receiving PNS and conventional medical management (CMM) or the control arm receiving CMM alone. Treatments were limited to the following areas: lower back, shoulder, knee and foot/ankle.