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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)

RecruitingNAAges 18 Years - 70 YearsAllRijnstate Hospital
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In plain words

What the trial is, and whether it could suit you

Spinal cord stimulation (SCS) has shown to be an effective treatment for patients with persistent spinal pain syndrome Type 2 (PSPS Type 2). The method used to deliver electrical charge in SCS is important. One such method is burst stimulation. Two variations of burst waveforms are currently in use: one that employs active recharge and one that uses passive recharge. It is still unknown if there are clinical differences between active recharge and passive recharge burst SCS. To date, no clinical studies have been performed that directly compared these two burst stimulation waveforms. The objective of this Randomized Clinical Trial (RCT) is to assess and compare effect of passive recharge burst SCS with active recharge burst SCS on pain relief and motivational-emotional facets of pain

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๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ35 * "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
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What it tests

  • Spinal cord stimulation using passive recharge burst stimulation
  • Spinal cord stimulation using active recharge burst stimulation
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Where

6 sites
Rijnstate Hospital
Arnhem, Netherlands
Bravis Hospital
Roosendaal, Netherlands
Elizabeth TweeSteden Hospital
Tilburg, Netherlands
Amsterdam University Medical Hospitals A-UMC
Amsterdam, Netherlands
Alrijne Hospital
Leiderdorp, Netherlands
Diakonessen Hospital
Zeist, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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