Clinical trial NCT06996574: Study to Compare the Clinical Effectiveness and Cost Utility of an All-in-one Procedure With an At-home Screening Trial
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neuromodulation
Chronic Pain Patients
Keywords: neuromodulation
chronic pain
SCS procedure
standard of care
Lead sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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. While screening trials allow patients to experience the therapy beforehand, they are costly, duplicative, and carry 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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline in Pain Intensity on the Numeric Rating Scale (NRS) at 6 Months
timeFrame: up to 6 months post lead implant
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Amsterdam UMC
name: Prof. dr. dr Hollmann W Prof. dr. dr.
role: PRINCIPAL_INVESTIGATOR
References: