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PET Patterns, Biomarkers and Outcome in Burst SCS Treated FBSS Patients

Unknown statusNot applicableNCT03419312
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

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
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