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Compares treatment options for Persistent Spinal Pain Syndrome Type 2
Official title 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)
ClinicalTrials.gov ID: NCT05421273
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- people 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
You likely can't join if
- 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
See the full eligibility criteria
- people 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 for the implantation of a neurostimulation system as typically utilized in the study center. PM: depression is not an
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Arnhem, Gelderland, Netherlands
- Roosendaal, North Brabant, Netherlands
- Tilburg, North Brabant, Netherlands
- Amsterdam, North Holland, Netherlands
- Leiderdorp, South Holland, Netherlands
- Zeist, Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Arnhem, Gelderland, Netherlands; Roosendaal, North Brabant, Netherlands; Tilburg, North Brabant, Netherlands; Amsterdam, North Holland, Netherlands; Leiderdorp, South Holland, Netherlands; Zeist, Utrecht, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.