Burst Crossover Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Burst Spinal Cord Stimulation, Sham spinal cord stimulation, SCS implant.
- Who it may be relevant to
- Registry conditions: Back Pain with Radiation, Pain, Postoperative. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Norway
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Spinal Cord Burst Stimulation for Chronic Radicular Pain Following Lumbar Spine Surgery: a Randomized Double-blind Sham-controlled Crossover Trial
Overview
Spinal cord stimulation (SCS) is a widely applied therapy to treat chronic neuropathic pain, and one of the most common indications is persisting radicular neuropathic pain following lumbar spine surgery. In traditional SCS therapies, the objective has been to replace the pain sensation with paresthesia. The anticipation is that the electrical current alters pain processing by masking the sensation of pain with a comfortable tingling or paresthesia. Although patients mostly cope with paresthesia, a significant proportion reports that the sensation is unpleasant. '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.
Interventions
- Procedure 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 - Procedure Sham spinal cord stimulation
No spinal cord stimulation is provided - Device 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
Primary outcome measures
- change in disease-specific functional outcome from baseline [Time frame: 12 months]
Secondary outcome measures (5)
- Change in generic health-related quality of life measured with the Euro-Qol-5D (5L) [Time frame: 12 months]
- Change in back pain [Time frame: 12 months]
- change in leg pain [Time frame: 12 months]
- Daily physical activity [Time frame: 12 months]
- Six-month follow-up of pain-related disability [Time frame: 18 months]
Eligibility criteria
Inclusion criteria
- Have undergone ≥1 back surgeries and developed chronic radicular pain that has remained refractory to non-surgical treatment for ≥6 months
- 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
- Coexisting conditions that would increase procedural risk (e.g., sepsis, coagulopathy)
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Norway · 1 center
- St Olavs Hospital — Trondheim
Identifiers
NCT: NCT05372822 · 2018/475-b