All-in-one spinal cord stimulation procedure versus an at-home screening period for chronic neuropathic pain
A Pragmatic Randomised Prospective Multi-centre Non-inferiority Trial in Chronic Pain Patients With Closed-loop Spinal Cord Stimulation (CL-SCS) to Compare the Clinical Effectiveness and Cost Utility of an All-in-one Procedure With an At-home Screening Trial
This project will test whether an all-in-one spinal cord stimulation procedure works as well as the usual at-home screening period for adults in the Netherlands with chronic neuropathic pain who are candidates for SCS.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) Academic / other |
| Locations | 1 site (Amsterdam) |
| Trial ID | NCT06996574 on ClinicalTrials.gov |
What this trial studies
This is a pragmatic, multi-centre randomized non-inferiority trial comparing an all-in-one spinal cord stimulation (SCS) implantation pathway with the current at-home screening period mandated for reimbursement in the Netherlands. Adult patients with chronic neuropathic pain meeting Dutch criteria (eg, PSPS, PDN, CRPS, SFN; pain ≥6 months and VAS ≥50 mm or NRS ≥5) will be randomized to either pathway. The trial will examine clinical outcomes such as pain reduction, complication rates (including infection), and cost-utility measures. Results are intended to inform clinical practice and reimbursement policy.
Who should consider this trial
Good fit: Adults (≥18) in the Netherlands with chronic neuropathic pain of ≥6 months, pain intensity ≥50 mm on VAS or ≥5 on NRS, and routinely selected for conventional lead SCS (eg, PSPS, PDN, CRPS, SFN) who can provide informed consent and complete study questionnaires are ideal candidates.
Not a fit: Patients with active infection, uncontrolled substance abuse, pregnancy, uninterruptible anticoagulation or coagulation disorders, life expectancy ≤12 months, or those who do not meet the pain intensity or documentation requirements are unlikely to receive benefit from the all-in-one approach in this trial.
Why it matters
Potential benefit: If successful, patients could avoid a separate at-home screening period and receive permanent SCS implantation faster with lower costs and potentially fewer screening-related infections.
How similar studies have performed: A prior UK randomized trial (TRIAL-STIM) found no significant difference in patient outcomes but higher costs with the screening-period strategy, so this approach has supporting evidence though not yet standard across the Netherlands.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Diagnosed with chronic, neuropathic pain with an approved aetiology in the Netherlands PSPS (persistent spinal pain syndrome) PDN (painful diabetic neuropathy) CRPS (complex regional pain syndrome) SFN (small fibre neuropathy) 2. Suitable candidate according to the inclusion criteria of the Dutch "Standpoint on Neuromodulation in Chronic Pain" Adult patients ≥18 years Chronic pain ≥6 months Pain intensity of ≥50mm or ≥5 on VAS- or NRS-score respectively 3. Routinely selected for CL-SCS 4. Be willing to complete additional trial related questionnaires 5. Be willing and capable of giving informed consent. Exclusion Criteria: 1. General exclusion criteria according to the Dutch "Standpoint on Neuromodulation in Chronic Pain": Drug abuse Pregnancy Coagulation disorder / Use of anticoagulation therapy which cannot be stopped temporarily Active infection Life expectation ≤12 months Intake questionnaires "PROMS neuromodulatie" not completed by the patient 2. Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS) 3. Current or previous treatment with an implanted pain reduction device 4. Participation in another clinical trial that may confound the results of this trial
Where this trial is running
Amsterdam
- Amsterdam UMC — Amsterdam, Netherlands (Recruiting)
Study contacts
- Principal investigator: Prof. dr. dr Hollmann W Prof. dr. dr. — Amsterdam UMC
- Study coordinator: E de Klerk S drs., Master of Science
- Email: e.s.deklerk@amsterdamumc.nl
- Phone: +31 (0)20 - 5662533
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.