Clinical Trial

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)

Study acronym: BURST-RAP
Recruiting
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Record status
This record was last updated November 19, 2024 (before its estimated December 31, 2025 completion). Its status may not reflect the trial's current state.
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
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-06-13; most recent amendment 2024-11-15.
Trial Details
NCT Number NCT05421273
Lead Sponsor Rijnstate Hospital
Conditions Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome
Enrollment 96 participants
Start Date 2022-02-16
Primary Completion 2025-12-31 (estimated)
Study Completion 2026-06-30 (estimated)
Updated on ClinicalTrials.gov 2024-11-19