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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| all-in-one (NTG) procedure | Experimental | all-in-one (NTG) procedure |
|
| the established two-phase closed-loop SCS procedure with at-home screening trials (TG) | Placebo Comparator | Standard of Care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Randomization | Other | The all-in-one (NTG) procedure versus the established two-phase closed-loop SCS procedure with at-home screening trials (TG) under everyday clinical practice, that can be used for clinical decision-making and to inform health policy decisions. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Pain Intensity on the Numeric Rating Scale (NRS) at 6 Months | 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. | up to 6 months post lead implant |
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Inclusion Criteria:
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| E de Klerk S drs., Master of Science | Contact | +31 (0)20 - 5662533 | e.s.deklerk@amsterdamumc.nl | |
| Carin Wensing drs, Master of Science | Contact | +31 (0)20 - 5662533 | a.g.wensing@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Prof. dr. dr Hollmann W Prof. dr. dr. | Amsterdam UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Recruiting | Amsterdam | Netherlands |
We will describe the specific IPD that will be shared
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non inferiority
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011897 | Random Allocation |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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