About this trial
Spinal cord stimulation (SCS) has shown to be an effective treatment for patients with persistent spinal pain syndrome Type 2 (PSPS Type 2). The method used to deliver electrical charge in SCS is important. One such method is burst stimulation. Two variations of burst waveforms are currently in use: one that employs active recharge and one that uses passive recharge. It is still unknown if there are clinical differences between active recharge and passive recharge burst SCS. To date, no clinical studies have been performed that directly compared these two burst stimulation waveforms. The objective of this Randomized Clinical Trial (RCT) is to assess and compare effect of passive recharge burst SCS with active recharge burst SCS on pain relief and motivational-emotional facets of pain
Eligibility criteria
Qualifiers
Subjects between 18 and 70 years of age
At least moderate level of catastrophizing as measured with the Pain catastrophizing scale (PCS) of at least 20 at first visit of the pain clinic.
Chronic pain diagnoses as PSPS Type 2 of at least 6 months
Neurologic exam without marked motor deficit.
Disqualifiers
Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation
Subject is able and willing to comply with the follow-up schedule and protocol
Subject is able to provide written informed consent
Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
Trial design
Treatments tested in this trial
- Spinal cord stimulation using passive recharge burst stimulation
- Spinal cord stimulation using active recharge burst stimulation