Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of Persistent Spinal Pain Syndrome Type II (PSPS-T2). Identification of clinical effective parameters concerning frequency, pulse duration, amplitude and battery consumption/recharge frequency and safety evaluation.
having chronic pain as a result of PSPS-T2 that exists for at least 6 months with at least moderate pain intensity (4 or higher measured on numeric rating scale (NRS) or 31mm or higher measured on visual analogue scale (VAS) for the dominant pain location.
being offered treatment with DTM SCS
being at least 18 years old
Expected inability of patients to properly operate the SCS system
History of coagulation disorders, lupus erythematosus, diabetic neuropathy
Active malignancy
Addiction to drugs and/or alcohol (more than 5 units /day)
Patients with Persistent Spinal Pain Syndrome type 2 (PSPS-T2), who will receive treatment with differential target multiplexed (DTM) SCS.
Cohort
Prospective
Spinal Cord Stimulation
DeviceDifferential target multiplexed stimulation
Overall pain intensity
The primary effectiveness outcome measure is pain intensity measured with the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 100 (maximal pain) in electronic format. Two scales will be presented for low back/neck pain and for leg/arm pain. Ecological momentary Assessment (EMA) will be used to collect pain intensity scores for VAS, whereby pain intensity is measured for multiple times per day for 1 week to reveal patterns of transient or fluctuating symptoms in the environment and context of the patients' lives, without a recall bias.
Pain intensity for the lower back and leg pain or neck and arm pain component
Pain intensity for the lower back and leg pain or neck and arm pain component will be assessed separately with the Numeric Rating Scale (0 to 10). Pain intensity for the last 7 days will be assessed in electronic format, with and without medication use.
Medication use
Open question regarding the use of medication (collected through ecological momentary assessment for 1 week).
Negative affect
Questions on a 9-point scale for negative affects, evaluated through ecological momentary assessment for 7 days.
Functional disability
The Oswestry disability index (ODI; 0 to 100) or Neck disability index (NDI; 0 to 100) is used to measure functional disability due to abnormalities of the spine
Click on the lead sponsor to view all of their trials.
