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Effects of Active Versus Passive Recharge Burst Spinal Cord Stimulation on Pain Experience in Persistent Spinal Pain Syndrome Type 2: a Multicenter Randomized Trial (BURST-RAP Study)
Sponsor: Rijnstate Hospital
Summary
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
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
96
Start Date
2022-02-16
Completion Date
2026-06-30
Last Updated
2024-11-19
Healthy Volunteers
No
Interventions
Spinal cord stimulation using passive recharge burst stimulation
Passive recharge burst is marked by a recharge pattern that passively compensates for charge differences.
Spinal cord stimulation using active recharge burst stimulation
Active recharge burst is characterized by negative pulses that directly compensate for charge differences.
Locations (6)
Rijnstate Hospital
Arnhem, Gelderland, Netherlands
Bravis Hospital
Roosendaal, North Brabant, Netherlands
Elizabeth TweeSteden Hospital
Tilburg, North Brabant, Netherlands
Amsterdam University Medical Hospitals A-UMC
Amsterdam, North Holland, Netherlands
Alrijne Hospital
Leiderdorp, South Holland, Netherlands
Diakonessen Hospital
Zeist, Utrecht, Netherlands