Status:
RECRUITING
Study to Compare the Clinical Effectiveness and Cost Utility of an All-in-one Procedure With an At-home Screening Trial
Lead Sponsor:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Conditions:
Neuromodulation
Chronic Pain Patients
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT06996574
Start Date
June 6 2025
End Date
April 1 2028
Last Update
July 10 2025
Active Locations (1)
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1
Amsterdam UMC
Amsterdam, Netherlands