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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Pain Intensity on the Numeric Rating Scale (NRS) at 6 Months
Study Overview
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. 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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)
- •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
- •Routinely selected for CL-SCS
- •Be willing to complete additional trial related questionnaires
- •Be willing and capable of giving informed consent.
Exclusion Criteria
- •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
- •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)
- •Current or previous treatment with an implanted pain reduction device
- •Participation in another clinical trial that may confound the results of this trial
Arms & Interventions
all-in-one (NTG) procedure
all-in-one (NTG) procedure
Intervention: Randomization (Other)
the established two-phase closed-loop SCS procedure with at-home screening trials (TG)
Standard of Care
Intervention: Randomization (Other)
Outcomes
Primary Outcomes
Change From Baseline in Pain Intensity on the Numeric Rating Scale (NRS) at 6 Months
Time Frame: up to 6 months post lead implant
Pain intensity will be assessed using the 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). The primary outcome is the change in NRS score from baseline to 6 months.
Secondary Outcomes
No secondary outcomes reported
Investigators
Professor Markus W Hollmann
Prof. dr. dr.
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)