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RECRUITING
NCT05421273
NA

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

View on ClinicalTrials.gov

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

DEVICE

Spinal cord stimulation using passive recharge burst stimulation

Passive recharge burst is marked by a recharge pattern that passively compensates for charge differences.

DEVICE

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