PET Patterns, Biomarkers and Outcome in Burst SCS Treated FBSS Patients (NCT03419312) | Clinical Trial Compass
UnknownNot Applicable
PET Patterns, Biomarkers and Outcome in Burst SCS Treated FBSS Patients
Sweden12 participantsStarted 2018-02-11
Plain-language summary
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).
Who can participate
Age range18 Years – 59 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Occurrence of chronic pain in the lumbosacral region, as well as unilateral or bilateral leg pain.
✓. Prior lumbar surgery in medical history.
✓. Diagnosed with neuropathic pain in the lower extremities and graded as probable neuropathic pain or definite neuropathic pain according International Association for the Study of Pain (IASP) criteria.
✓. Patient report largely unchanged pain condition last 6 months.
✓. Patient has undergone a 7 day SCS trial with epidural burst stimulation with the following results:
✓. At least 75% coverage of the painful area of tonic stimulation before start of burst trial stimulation.
✓. At least 50% reduction in pain intensity, measured via BPI, item 5 from baseline of trial to end of trial period.
✓. The patient is ≥ 18 years of age and \< 60 years of age.
Exclusion criteria
✕. The patient has other current pain conditions than back and leg pain after back surgery.
✕. The patient is treated with opioids exceeding 80 milligrams of Morphine per day or is considered at risk for development of problematic opioid use.
✕. The patient suffers from an untreated depression or anxiety.
✕. The patient can not complete the study plan.
What they're measuring
1
Change in regional cerebral blood flow measured with 15O-water Positron Emission. Tomography (PET)
Timeframe: PET is performed at study day 0 (baseline), day 14 and day 35.