PET Patterns, Biomarkers and Outcome in Burst SCS Treated FBSS Patients
Unknown statusNot applicableNCT03419312
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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).
Study details
- 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
- Conditions
- Fbss
- Pain, Intractable
- Low Back Pain
- Radicular
- Neuropathic, Lumbar, Lumbosacral
- Interventions
- Device: Proclaim™ Elite 5: Burst - Washout - Sham
- Device: Proclaim™ Elite 5: Sham - Washout - Burst
- Sponsor
- Uppsala University
- Collaborators
- Linkoeping University; Boston Children's Hospital
- Start date
- 2018-02-11
- Primary completion
- 2021-06
- Sex
- All
- Age range
- from 18 Years to 59 Years
- Results posted
- No results posted in this snapshot
- Countries
- Sweden
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Occurrence of chronic pain in the lumbosacral region, as well as unilateral or bilateral leg pain. 2. Prior lumbar surgery in medical history. 3. 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. 4. Patient report largely unchanged pain condition last 6 months. 5. Patient has undergone a 7 day SCS trial with epidural burst stimulation with the following results: 1. At least 75% coverage of the painful area of tonic stimulation before start of burst trial stimulation. 2. At least 50% reduction in pain intensity, measured via BPI, item 5 from baseline of trial to end of trial period. 6. The patient is ≥ 18 years of age and \< 60 years of age. 7. The patient must willingly participate in all parts of the study, as well as having the ability to complete the entire study plan. 8. Patient must certify that he / she understands the study plan, as well as voluntarily sign informed consent to participate in the study. 9. Must be able to sit still for a minimum of 45 minutes and be able to follow restrictions related to the PET survey. Exclusion Criteria: 1. The patient has other current pain conditions than back and leg pain after back surgery. 2. The patient is treated with opioids exceeding 80 milligrams of Morphine per day or is considered at risk for development of problematic opioid use. 3. The patient suffers from an untreated depression or anxiety. 4. The patient can not complete the study plan. 5. The patient is unable to read or write Swedish. 6. The patient is currently participates in another clinical trial. 7. A history of previous PET scan or other substantial radiation dose in the last 5 years. 8. The patients is suffering from claustrophobia. 9. Ongoing pregnancy or planned pregnancy during study time. 10. The patient has contraindications for arterial catheterization. 11. The patient is previously treated with spinal cord stimulation.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03419312