Comparing active and passive spinal cord stimulation for chronic pain relief
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)
NA · Rijnstate Hospital · NCT05421273
This study is testing two types of spinal cord stimulation to see which one helps people with chronic pain feel better over a year.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Rijnstate Hospital (other) |
| Locations | 6 sites (Arnhem, Gelderland and 5 other locations) |
| Trial ID | NCT05421273 on ClinicalTrials.gov |
What this trial studies
This multicenter randomized clinical trial aims to evaluate the effectiveness of two types of burst spinal cord stimulation (SCS) - active recharge and passive recharge - in patients suffering from Persistent Spinal Pain Syndrome Type 2. A total of 96 participants will be recruited from six hospitals in the Netherlands and will be randomly assigned to receive either type of stimulation. The study will assess pain relief and emotional aspects of pain through various questionnaires over a 12-month period following implantation. The primary outcome will be measured using the pain catastrophizing score at six months, alongside several secondary outcomes to provide a comprehensive understanding of the treatment effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with chronic pain from Persistent Spinal Pain Syndrome Type 2 and a moderate level of pain catastrophizing.
Not a fit: Patients with acute pain conditions or those who do not meet the inclusion criteria for spinal cord stimulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients with chronic spinal pain.
How similar studies have performed: While spinal cord stimulation has been widely studied, this specific comparison of active versus passive recharge burst stimulation is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Arnhem, Gelderland and 5 other locations
- Rijnstate Hospital — Arnhem, Gelderland, Netherlands (RECRUITING)
- Bravis Hospital — Roosendaal, North Brabant, Netherlands (RECRUITING)
- Elizabeth TweeSteden Hospital — Tilburg, North Brabant, Netherlands (RECRUITING)
- Amsterdam University Medical Hospitals A-UMC — Amsterdam, North Holland, Netherlands (RECRUITING)
- Alrijne Hospital — Leiderdorp, South Holland, Netherlands (NOT_YET_RECRUITING)
- Diakonessen Hospital — Zeist, Utrecht, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Martijn Mons, Msc.
- Email: m.mons@maastrichtuniversity.nl
- Phone: +31433881034
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome