Actively Recruiting
Led by Rijnstate Hospital · Updated on 2024-11-19
96
Participants Needed
6
Research Sites
25 weeks
Total Duration
Researchers are evaluating the effects of two types of burst spinal cord stimulation (SCS) on pain relief and emotional aspects of pain in patients with Persistent Spinal Pain Syndrome Type 2 (PSPS Type 2), also known as Failed Back Surgery Syndrome. The trial compares active recharge burst SCS versus passive recharge burst SCS, as no prior clinical studies have directly compared these two waveform methods. This randomized clinical trial aims to improve understanding of how different burst waveforms influence pain experience. The trial enrolls 96 patients across six Dutch hospitals who are randomly assigned to receive either active recharge or passive recharge burst SCS. After a successful trial period, patients will be permanently implanted with the assigned device. Active recharge burst uses negative pulses to directly compensate for charge differences, while passive recharge burst passively compensates for charge differences. Treatments are assessed over 12 months following implantation. Participants will complete various assessments including the Pain Catastrophizing Scale (PCS) at 6 months as the primary outcome. Secondary measures include pain ratings, patient vigilance, anxiety and depression scales, quality of life, disability index, patient global impression of change, and painDETECT questionnaires at baseline, after trial, and at 1, 3, 6, and 12 months post-implantation. The study monitors device usage and collects patient-reported outcomes to evaluate differences in pain relief and emotional response.
CONDITIONS
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)
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of trial period until permanent implantation
Participants undergo a trial period of spinal cord stimulation using either active or passive recharge burst stimulation. Following a successful trial period, participants are permanently implanted with the neurostimulation device.
1 to 2 visits during trial period and implantation procedure
Duration - 12 months following implantation
Participants receive spinal cord stimulation treatment with the implanted device and complete assessments of pain and quality of life at multiple time points.
Visits at baseline, after trial, and at 1, 3, 6, and 12 months post-implantation
Total: 6 locations
1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6815 AD
Actively Recruiting
2
Bravis Hospital
Roosendaal, North Brabant, Netherlands, 4708 AE
Actively Recruiting
3
Elizabeth TweeSteden Hospital
Tilburg, North Brabant, Netherlands, 5042 AD
Actively Recruiting
4
Amsterdam University Medical Hospitals A-UMC
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
5
Alrijne Hospital
Leiderdorp, South Holland, Netherlands, 2353 GA
Not Yet Recruiting
6
Diakonessen Hospital
Zeist, Utrecht, Netherlands, 3707 HL
Actively Recruiting
M
Martijn Mons, Msc.
J
Jan-Willem Kallewaard, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Martijn R Mons, Caro Edelbroek, Xander Zuidema...
https://pubmed.ncbi.nlm.nih.gov/36064598