Status:
UNKNOWN
PET Patterns, Biomarkers and Outcome in Burst SCS Treated FBSS Patients
Lead Sponsor:
Uppsala University
Collaborating Sponsors:
Linkoeping University
Boston Children's Hospital
Conditions:
FBSS
Pain, Intractable
Eligibility:
All Genders
18-59 years
Phase:
NA
Brief 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 ba...
Detailed Description
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 an...
Eligibility Criteria
Inclusion
- 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.
- The patient must willingly participate in all parts of the study, as well as having the ability to complete the entire study plan.
- Patient must certify that he / she understands the study plan, as well as voluntarily sign informed consent to participate in the study.
- Must be able to sit still for a minimum of 45 minutes and be able to follow restrictions related to the PET survey.
Exclusion
- 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.
- The patient is unable to read or write Swedish.
- The patient is currently participates in another clinical trial.
- A history of previous PET scan or other substantial radiation dose in the last 5 years.
- The patients is suffering from claustrophobia.
- Ongoing pregnancy or planned pregnancy during study time.
- The patient has contraindications for arterial catheterization.
- The patient is previously treated with spinal cord stimulation.
Key Trial Info
Start Date :
February 11 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03419312
Start Date
February 11 2018
End Date
June 1 2021
Last Update
April 8 2020
Active Locations (1)
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1
Uppsala University Hospital, Uppsala University, Dept. of Surgical Sciences and Dept. of Medicinal Chemistry, Div. of Molecular Imaging.
Uppsala, Sweden, 75185