Actively Recruiting
Study to Compare the Clinical Effectiveness and Cost Utility of an All-in-one Procedure With an At-home Screening Trial
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-07-10
180
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study to Compare the Clinical Effectiveness and Cost Utility of an All-in-one Procedure With an At-home Screening Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with chronic neuropathic pain with approved causes in the Netherlands: persistent spinal pain syndrome, painful diabetic neuropathy, complex regional pain syndrome, or small fibre neuropathy
- Adult patients aged 18 years or older
- Chronic pain lasting at least 6 months
- Pain intensity of 50mm or higher on the Visual Analog Scale (VAS) or 5 or higher on the Numeric Rating Scale (NRS)
- Routinely selected for closed-loop spinal cord stimulation (CL-SCS)
- Willing to complete additional trial-related questionnaires
- Willing and capable of giving informed consent
You will not qualify if you...
- Drug abuse
- Pregnancy
- Coagulation disorder or use of anticoagulation therapy that cannot be paused temporarily
- Active infection
- Life expectancy of 12 months or less
- Incomplete intake questionnaires "PROMS neuromodulatie"
- Existing drug pump, spinal cord stimulator, or other active implantable devices such as pacemaker, deep brain stimulator, or sacral nerve stimulator
- Current or previous treatment with an implanted pain reduction device
- Participation in another clinical trial that may affect this study's results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
Research Team
E
E de Klerk S drs., Master of Science
CONTACT
C
Carin Wensing drs, Master of Science
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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