RecruitingNot Applicable

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)

Netherlands96 participantsStarted 2022-02-16

Plain-language summary

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

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 assess…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Pain catastrophizing score

Timeframe: 6 months

Trial details

NCT IDNCT05421273

SponsorRijnstate Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

Contact for this trial

Martijn Mons, Msc.

+31433881034 m.mons@maastrichtuniversity.nl

View on ClinicalTrials.gov More Persistent Spinal Pain Syndrome Type 2 trials