Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
50 participants
INTERVENTIONAL
2021-05-01
2025-08-15
Brief Summary
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'Burst' SCS utilizes complex programming to deliver high-frequency stimuli. This SCS technique seems to provide paresthesia-free stimulation, resulting in better pain relief of low back and leg pain then traditional tonic stimulation.
The widespread use of SCS has not been backed by solid evidence. The absence of placebo-controlled trials has long been an important point of criticism, but due to the nature of the intervention with sensation of paresthesia, studies with placebo control have so far not been considered possible. When 'burst' SCS is used the stimulation is often unnoticed by the patient, allowing comparison with placebo stimulation.
The aim of this randomized double-blind sham-controlled crossover trial is to evaluate the efficacy of 'burst' spinal cord stimulation for chronic radicular pain following spine surgery.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Burst SCS
Burst Spinal cord stimulation. SCS system implanted and burst stimulation given
Burst Spinal Cord Stimulation
Burst stimulation utilizes complex programming to deliver high-frequency stimuli of a 40 Hz burst mode with 5 spikes at 500 Hz per spike delivered in a constant current mode
Sham spinal cord stimulation
No spinal cord stimulation is provided
SCS implant
a subcutaneously implantable pulse generator ("pacemaker") for long-term therapy.
The following system from Abbott will be implanted: ProclaimTM XR implantable pulse generator and Octrode® 8-contact lead
Sham SCS
Sham spinal cord stimulation. SCS system implanted but no stimulation given.
Burst Spinal Cord Stimulation
Burst stimulation utilizes complex programming to deliver high-frequency stimuli of a 40 Hz burst mode with 5 spikes at 500 Hz per spike delivered in a constant current mode
Sham spinal cord stimulation
No spinal cord stimulation is provided
SCS implant
a subcutaneously implantable pulse generator ("pacemaker") for long-term therapy.
The following system from Abbott will be implanted: ProclaimTM XR implantable pulse generator and Octrode® 8-contact lead
Interventions
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Burst Spinal Cord Stimulation
Burst stimulation utilizes complex programming to deliver high-frequency stimuli of a 40 Hz burst mode with 5 spikes at 500 Hz per spike delivered in a constant current mode
Sham spinal cord stimulation
No spinal cord stimulation is provided
SCS implant
a subcutaneously implantable pulse generator ("pacemaker") for long-term therapy.
The following system from Abbott will be implanted: ProclaimTM XR implantable pulse generator and Octrode® 8-contact lead
Eligibility Criteria
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Inclusion Criteria
* Minimum pain intensity of 5/10 on the leg pain NRS at baseline
* Successful two-week SCS testing period with tonic stimulation (≥2 points reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period
* Mandatory assessment at the Multidisciplinary outpatient clinic for back-, neck- and shoulder rehabilitation, St. Olavs University Hospital
* Successful two-week SCS testing period with tonic stimulation (≥50% reduction in leg pain NRS from baseline). This means patients will experience paresthesia during the SCS trial period
Exclusion Criteria
* History of laminectomy or posterior fusion at the thoracolumbar junction, where percutaneous electrode end tips are routinely placed.
* Abnormal pain behavior and/or unresolved psychiatric illness.
* Unresolved issues of secondary gain or inappropriate medication use.
18 Years
ALL
No
Sponsors
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Norwegian University of Science and Technology
OTHER
St. Olavs Hospital
OTHER
Responsible Party
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Principal Investigators
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Sasha Gulati, md prof
Role: PRINCIPAL_INVESTIGATOR
St. Olavs Hospital
Geir Bråthen, md prof
Role: STUDY_DIRECTOR
St. Olavs Hospital
Locations
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St Olavs Hospital
Trondheim, , Norway
Countries
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Central Contacts
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Facility Contacts
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Sasha Gulati, md phd
Role: primary
Other Identifiers
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2018/475-b
Identifier Type: -
Identifier Source: org_study_id