All-in-one spinal cord stimulation procedure versus an at-home screening period for chronic neuropathic pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.