Status:
RECRUITING
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)
Lead Sponsor:
Rijnstate Hospital
Conditions:
Persistent Spinal Pain Syndrome Type 2
Failed Back Surgery Syndrome
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 impo...
Detailed Description
This multicenter randomized clinical trial will take place in 6 Dutch hospitals: the Rijnstate Hospital (Arnhem), Bravis Hospital (Roosendaal), Elizabeth TweeSteden Hospital (Tilburg), Diakonessen Hos...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 16 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT05421273
Start Date
February 16 2022
End Date
June 30 2026
Last Update
November 19 2024
Active Locations (6)
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1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6815 AD
2
Bravis Hospital
Roosendaal, North Brabant, Netherlands, 4708 AE
3
Elizabeth TweeSteden Hospital
Tilburg, North Brabant, Netherlands, 5042 AD
4
Amsterdam University Medical Hospitals A-UMC
Amsterdam, North Holland, Netherlands, 1105 AZ