Actively 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)
Led by Rijnstate Hospital · Updated on 2024-11-19
96
Participants Needed
6
Research Sites
227 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects between 18 and 70 years of age
- Pain catastrophizing scale score of at least 20 at first pain clinic visit
- Chronic pain diagnosis of Persistent Spinal Pain Syndrome Type 2 for at least 6 months
- Neurologic exam without marked motor deficit
- Low back and/or leg pain intensity of 5 or higher on an 11-point numeric rating scale
- Meets inclusion criteria for neurostimulation implantation used in the study center
- Screened and deemed suitable for implantation by a multi-disciplinary panel including a psychologist
- Able and willing to comply with follow-up schedule and protocol
- Able to provide written informed consent
You will not qualify if you...
- Female of childbearing potential who is pregnant, nursing, or planning pregnancy during the study
- Escalating or changing pain condition within the past month
- Body mass index (BMI) of 35 or higher
- Injection therapy or radiofrequency treatment for low back or leg pain within past 3 months
- Currently has an active implantable device such as ICD, pacemaker, spinal cord stimulator, or intrathecal drug pump
- Unable to operate the study device
- Severe spinal degeneration likely to cause technical problems
- Previous neurostimulation therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Rijnstate Hospital
Arnhem, Gelderland, Netherlands, 6815 AD
Actively Recruiting
2
Bravis Hospital
Roosendaal, North Brabant, Netherlands, 4708 AE
Actively Recruiting
3
Elizabeth TweeSteden Hospital
Tilburg, North Brabant, Netherlands, 5042 AD
Actively Recruiting
4
Amsterdam University Medical Hospitals A-UMC
Amsterdam, North Holland, Netherlands, 1105 AZ
Actively Recruiting
5
Alrijne Hospital
Leiderdorp, South Holland, Netherlands, 2353 GA
Not Yet Recruiting
6
Diakonessen Hospital
Zeist, Utrecht, Netherlands, 3707 HL
Actively Recruiting
Research Team
M
Martijn Mons, Msc.
CONTACT
J
Jan-Willem Kallewaard, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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