Low Back Pain Clinical Trial
Official title:
Cerebral PET Patterns, Inflammatory Biomarkers and Outcome in Patients Treated With Burst Spinal Cord Stimulation for Chronic Low Back and Leg Pain: A Randomized Controlled Clinical Trial
The primary aim of this study is to investigate cerebral mechanisms of burst stimulation in Failed Back Surgery Syndrome (FBSS) patients treated with Burst Spinal Cord Stimulation (SCS) for chronic back and leg pain. This study is a single center, prospective, blinded, randomized crossover trial with two 14 days treatment periods and two treatment arms (burst before sham stimulation or sham before burst stimulation).
Background and rationale:
Tonic spinal cord stimulation for chronic primarily neuropathic pain har been used for over
50 years. Tonic stimulation in frequencies from 20 to 70 Hz produces analgesia and
paresthesia in the targeted area.
Burst stimulation, a novel spinal cord stimulation pattern, is an intermittent high frequency
parenthesis-free therapy. This stimulation pattern consist of 5 spikes with an inter-spike
frequency of 500 Hz, delivered at 40 Hz.
Clinical effectiveness and noninferiority of Burst stimulation has been proved. A few studies
suggest that Burst stimulation induce different activities in cerebral pathways, compared
with tonic stimulation. Patient reported attention to pain assessed by the pain vigilance and
awareness questionnaire (PVAQ) seems to differ between burst and tonic spinal cord
stimulation. This trial is designed to investigate cerebral mechanisms of burst stimulation,
using PET O15-water measured blood flow and tissue perfusion as a proxy for cerebral
activity.
Key events in study implementation:
Study phase 1
- Study Inclusion and baseline visit.
- Implantation of spinal cord stimulation system.
Study phase 2:
- Study visit 1(study day 0): Collection of Patient Reported Outcome Measurements (PROM)
data, Randomization to study sequence, blood sampling, PET 0, programming of SCS-system.
- Study visit 2 (study day 14): Blood sampling, PET 1, collection of PROM-data, SCS system
switched off for washout.
- Study visit 3 (study day 21): Collection of PROM-data, programming of SCS-system, blood
sampling.
- Study visit 4 (study day 35): Blood sampling, PET 2, collection of PROM-data,
programming of SCS-system.
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