Condition: Neuromodulation · Chronic Pain Patients · Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
In 2019, the Dutch Healthcare Institute published a consensus report outlining when spinal cord stimulation (SCS) for chronic pain qualifies for reimbursement under Dutch health insurance. It mandates that adult patients with significant pain (VAS ≥50mm or NRS ≥5) undergo an at-home screening trial, which must show at least 50% pain reduction to proceed with permanent implantation. Screening trials give patients early access to the therapy, but they are expensive, often redundant, and pose risks such as infection. A recent UK study (TRIAL-STIM) found no significant difference in outcomes between patients who had screening trials and those who received an all-in-one SCS procedure, but the trial strategy incurred greater costs. Given these findings, and the fact that all-in-one procedures are already used in certain Dutch cases, it is reasonable to evaluate this approach more broadly. Therefore, a pragmatic, multi-centre, randomized non-inferiority trial will compare the effectiveness of the all-in-one procedure, no trial group (NTG) to the standard two-step approach, trial group (TG) in Dutch patients with chronic neuropathic pain.
This description comes directly from the study's public registry record.
E de Klerk S drs., Master of Science · +31 (0)20 - 5662533 · e.s.deklerk@amsterdamumc.nl
Carin Wensing drs, Master of Science · +31 (0)20 - 5662533 · a.g.wensing@amsterdamumc.nl
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| Amsterdam UMC | Amsterdam, Netherlands | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06996574