The holistic response of patients with Persistent Spinal Pain Syndrome Type II by Subthreshold Spinal Cord Stimulation compared to Best Medical Treatment, investigated by a Multicentric Randomized Controlled Trial.
A multicenter randomized controlled trial will be conducted in patients with chronic back and leg pain (due to Persistent Spinal Pain Syndrome Type II) who previously underwent a minimum of one spinal surgery and are eligible for SCS. The primary scientific objective is to examine whether subthreshold Spinal Cord Stimulation (SCS), compared to best medical treatment (BMT), provided to patients with Persistent Spinal Pain Syndrome Type II (PSPS T2) results in a higher percentage of clinical holistic responders at 6 months. The secondary objective of the study is to examine if subthreshold SCS compared with BMT is having more efficacy in improving patients' individual competencies for self-management, increasing the likelihood to return to work, work status and healthcare expenditure, improving pain relief, obtaining pain medication reduction, decreasing anxiety and depression, increasing quality of life and decreasing disability.
The novelty of this project is the holistic outcome responder as primary outcome variable of this trial. We firmly believe that there is a need to redefine success of a treatment in chronic pain management, wherefore the primary outcome variable is in line with this reasoning. In order to be considered a holistic responder, a clinical important improvement should be made on all five components:
- UZ Brussel
- AZ Delta
- AZ Turnhout
- AZ Sint-Maarten
Number of included patients
- Study is currently recruiting patients.
- Four sites are eligible to recruit patients at this time.