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)

Launched by RIJNSTATE HOSPITAL · Jun 13, 2022

Keywords

ClinConnect Summary

The BURST-RAP Study is a research trial that is looking at how different methods of spinal cord stimulation (SCS) can help relieve pain for people suffering from Persistent Spinal Pain Syndrome Type 2 (PSPS Type 2) or Failed Back Surgery Syndrome. Specifically, the study compares two types of burst stimulation: one that uses active recharge and one that uses passive recharge. Researchers want to find out if there are any differences in pain relief and emotional well-being between these two methods.

To participate in this trial, you need to be between 18 and 70 years old, have experienced chronic pain for at least six months, and have a certain level of pain intensity. You should also be willing to follow the study's guidelines and provide written consent. Those who are pregnant, have recently received certain treatments for pain, or have specific health issues may not be eligible. If you join the study, you can expect close monitoring and support throughout the process, helping researchers understand which stimulation method works better for pain management.

Gender

ALL

Eligibility criteria

• 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