Effects of Active Versus Passive Recharge Burst Spinal Cord Stimulation on Pain Experience in Persistent Spinal Pain Syndrome Type 2: a Multicenter Randomized Trial (BURST-RAP Study)

This multicenter randomized clinical trial will take place in 6 Dutch hospitals: the Rijnstate Hospital (Arnhem), Bravis Hospital (Roosendaal), Elizabeth TweeSteden Hospital (Tilburg), Diakonessen Hospital (Utrecht), Alrijne Hospital (Leiden) and the Amsterdam University Medical Hospitals A-UMC). PSPS Type II2 patients (n=96) will be randomized into a group receiving either active or passive recharge burst. Following a successful trial period, patients are permanently implanted. Patients complete the pain catastrophizing score (PCS) (primary outcome at 6 months), numeric pain rating scale (NRS), patient vigilance and awareness questionnaire (PVAQ), hospital anxiety and depression scale (HADS), quality of life (EQ-5D), Oswestery disability index (ODI), patient global impression of change (PGIC) and painDETECT questionnaires (secondary outcomes) at baseline, after trial, 1, 3, 6 and 12 months following implantation.

Inclusion criteria

• Subjects between 18 and 70 years of age
• At least moderate level of catastrophizing as measured with the Pain catastrophizing scale (PCS) of at least 20 at first visit of the pain clinic.
• Chronic pain diagnoses as PSPS Type 2 of at least 6 months
• Neurologic exam without marked motor deficit.
• LBP and/or leg pain intensity should be 5 or higher measured with the 11-box NRS 0-10
• Meets all the inclusion criteria for the implantation of a neurostimulation system as typically utilized in the study center. PM: depression is not an exclusion criteria
• Subject has been screened by a multi-disciplinary panel including a psychologist and deemed suitable for implantation
• Subject is able and willing to comply with the follow-up schedule and protocol
• Subject is able to provide written informed consent

Exclusion criteria

• Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the study
• Escalating or changing pain condition within the past month as evidenced by investigator examination
• BMI ≥35
• "Subject has had injection therapy or radiofrequency treatment for their low back pain (LBP) or leg pain within the past 3 months"
• Subject currently has an active implantable device including ICD, pacemaker, spinal cord stimulator or intrathecal drug pump
• Subject is unable to operate the device
• Severe spinal column degeneration likely to cause technical problems with neuromodulation, to be assessed by the treating physician
• Previous Neurostimulation therapy