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

Launched by ACADEMISCH MEDISCH CENTRUM - UNIVERSITEIT VAN AMSTERDAM (AMC-UVA) · May 21, 2025

Keywords

ClinConnect Summary

This clinical trial is designed to compare two different approaches for treating chronic pain using spinal cord stimulation (SCS). One group of patients will undergo a traditional two-step process, which involves an at-home screening trial to test if the treatment helps reduce their pain before getting a permanent device. The other group will receive an all-in-one procedure where they get the device implanted right away, without the prior screening. The goal is to see if the all-in-one method is just as effective and can save costs, as previous studies have suggested there may not be a big difference in pain relief between the two methods.

To participate in the trial, individuals must be at least 18 years old and have chronic neuropathic pain for more than six months, with a specific level of pain intensity. They should not have certain medical conditions or devices already implanted in their body. Participants will be asked to complete some questionnaires related to their pain management during the trial. This study aims to provide valuable information that could potentially change how chronic pain is treated in the future, making it easier and more efficient for patients.

Gender

ALL

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