Actively Recruiting
A Pragmatic Randomised Multi-centre Trial Comparing an All-in-one Procedure to At-home Screening Trial in Chronic Pain Patients Using Closed-loop Spinal Cord Stimulation
Led by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Updated on 2025-07-10
180
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and cost utility of an all-in-one spinal cord stimulation (SCS) procedure compared to the standard two-step approach that includes an at-home screening trial. This pragmatic, multi-center, randomized non-inferiority trial focuses on adult patients in the Netherlands with chronic neuropathic pain conditions such as persistent spinal pain syndrome, painful diabetic neuropathy, complex regional pain syndrome, and small fibre neuropathy. The study aims to assess whether the all-in-one procedure is as effective as the traditional screening trial method, which can be costly and carry risks like infection. Participants are randomly assigned to either the all-in-one procedure group (no trial group, NTG) or the standard two-phase closed-loop SCS procedure with an at-home screening trial group (trial group, TG). Both approaches involve closed-loop SCS, with the trial group undergoing a temporary screening trial to confirm at least 50% pain reduction before permanent implantation. The all-in-one group receives the full implantation procedure without prior screening. Treatments are delivered under everyday clinical practice settings to inform clinical decisions and health policy. During the study, participants will be monitored for changes in pain intensity using the Numeric Rating Scale (NRS) up to six months after lead implantation. They are also asked to complete additional trial-related questionnaires. Researchers will evaluate pain reduction and cost utility between the two approaches. The study includes single masking and randomization with follow-up visits and assessments to track outcomes and safety throughout the trial period, which begins in June 2025 and is expected to conclude by April 2028.
CONDITIONS
Brief Title
Study to Compare the Clinical Effectiveness and Cost Utility of an All-in-one Procedure With an At-home Screening Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with chronic neuropathic pain such as persistent spinal pain syndrome, painful diabetic neuropathy, complex regional pain syndrome, or small fibre neuropathy
- Adult patients aged 18 years or older
- Chronic pain for at least 6 months
- Pain intensity of 50mm or higher on VAS or 5 or higher on NRS
- Suitable candidates for closed-loop spinal cord stimulation
- Willing to complete additional trial-related questionnaires
- Able to give informed consent
You will not qualify if you...
- History of drug abuse, pregnancy, coagulation disorders, or use of anticoagulation therapy that cannot be temporarily stopped
- Active infection
- Life expectancy of less than 12 months
- Incomplete intake questionnaires "PROMS neuromodulatie"
- Existing drug pump, spinal cord stimulation system, or other active implantable devices like pacemakers, deep brain stimulators, or sacral nerve stimulators
- Current or previous treatment with an implanted pain reduction device
- Participation in another clinical trial that may affect the results of this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months post lead implant
Participants receive either an all-in-one procedure or the established two-phase closed-loop spinal cord stimulation procedure with an at-home screening trial as part of their chronic pain management.
Visits scheduled according to the treatment protocol during 6 months
Trial Site Locations
Total: 1 location
1
Amsterdam UMC
Amsterdam, Netherlands
Actively Recruiting
Research Team
E
E de Klerk S drs., Master of Science
C
Carin Wensing drs, Master of Science
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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