Differential Target Multiplexed Spinal Cord Stimulation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMoens Maarten
About this trial
Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of chronic back and leg pain. Additionally, a subgroup analysis will be performed to evaluate potential differences between paddle/surgical leads versus percutaneous leads.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with severe chronic pain (> 5 on numeric rating scale, NRS) for at least 6 months due to FBSS (PSPS T2) and suitable for treatment with DTM SCS according to the treating physician
Age > 18 years
Patient has been informed of the study procedures and has given written informed consent
Patient willing to comply with study protocol including attending the study visits
Disqualifiers
Expected inability of the patient to receive or properly operate the spinal cord stimulation system
History of coagulation disorder, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis, or morbus Bechterew
Active malignancy
Addiction to drugs, alcohol (>5 units per day) and/or medication
Trial population
Patients with chronic back and leg pain due to Failed Back Surgery Syndrome (FBSS)/Persistent Spinal Pain Syndrome type 2 (PSPS-T2), who will receive treatment with differential target multiplexed (DTM) SCS.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Spinal Cord Stimulation
Devicedifferential target multiplexed stimulation
Treatment groups
250 Participants
are divided into 1 treatment groupGroup A: Spinal cord stimulation1 intervention
Trial outcomes
Primary outcomes
1
Overall pain intensity with Visual Analogue Scale (VAS)
Overall pain, defined as a combination of back and leg pain, but not pain from other body parts, measured with the VAS (100mm)
Time frame
The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 monthsSecondary outcomes
1
Back pain intensity with Visual Analogue Scale (VAS)
Time frame
The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months2
Leg pain intensity with Visual Analogue Scale (VAS)
Time frame
The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months3
Pain medication use
Open question regarding the dosage, frequency and type of pain medication
Time frame
The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months4
Functional disability
The functional disabilities will be assessed with the Oswestry Disability Index (ODI)
Time frame
The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Moens Maarten
Lead sponsor
Universitair Ziekenhuis Brussel
Sponsor institution
Source ClinicalTrials.gov