Study to Compare the Clinical Effectiveness and Cost Utility of an All-in-one Procedure With an At-home Screening Trial

NCT06996574 | Recruiting DMC

• 1 other identifier: 2024.1119
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuromodulation; Chronic Pain Patients

Keywords

neuromodulation; chronic pain; SCS procedure; standard of care

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

all-in-one (NTG) procedure

EXPERIMENTAL

all-in-one (NTG) procedure

Other: Randomization

the established two-phase closed-loop SCS procedure with at-home screening trials (TG)

PLACEBO COMPARATOR

Standard of Care

Other: Randomization

Interventions

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.

all-in-one (NTG) procedure; the established two-phase closed-loop SCS procedure with at-home screening trials (TG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Routinely selected for CL-SCS
• Be willing to complete additional trial related questionnaires
• Be willing and capable of giving informed consent.

You may not qualify if:

• 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

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead

Study Sites (1)

Amsterdam UMC

Amsterdam, Netherlands

RECRUITING

MeSH Terms

Conditions

Chronic Pain

Interventions

Random Allocation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Prof. dr. dr Hollmann W Prof. dr. dr.

  Amsterdam UMC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr. dr.

Model Details: non inferiority

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 30, 2025
• Study Start: June 6, 2025
• Primary Completion (Estimated): April 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)