State-of-the-art nuclear neuroimaging in failed back surgery syndrome: can we predict the outcome?
- Conditions
- Post-laminectomy syndromepersistent lower back and/or leg pain after spinal surgery10041543
- Registration Number
- NL-OMON51773
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 20
• Aged between 18 and 75 years
• Diagnosed with FBSS with low back pain radiating in lumbar segments L4, L5
and S1 with or without pain in the lower limbs
• Experienced chronic pain for >= six months with a pain score >= 5 for the
weighted Visual Analogue Scale (VAS)
• No option for further surgical intervention
• Previous pain treatments have been unsuccessful (insufficient pain relief or
unacceptable side effects)
• Psychologically screened
• Willing to provide informed consent
• Scheduled to receive neurostimulation treatment (i.e., SCS)
participation in this study:
• Younger than 18 years old
• Presence of clinically significant (e.g., Alzheimer*s disease, frontotemporal
dementia, Parkinson*s disease) or disabling chronic pain condition as this will
limit the validity of PET-CT imaging and the outcome of SCS treatment. To test
for neurodegenerative disorders, well-validated, Dutch versions of the
mini-mental state examination (MMSE) and the frontal assessment battery (FAB)
tests will be used
• Patients with diabetes mellitus (either type I or type II)
• The expected inability of the patients to properly operate the
neurostimulation system
• A previous SCS procedure
• Addiction to drugs, alcohol (>= 5 E / day) or medication
• Insufficient cooperation (lack of motivation, understanding)
• History of coagulation disorders, lupus erythematosus, diabetes mellitus,
rheumatoid arthritis or Morbus Bechterew
• Current use of medication affecting coagulation which cannot be temporarily
stopped
• Medication usage that could interfere with biodistribution of F18-FDG tracer
(e.g., benzodiazepines, barbiturates)
• An inability to speak or understand the Dutch language
• Life expectancy < 1 year
• Patients with a pacemaker
• Local infection or other skin problems in the operation area
• Existing or planned pregnancy
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The main study parameter is metabolic glucose activity of cerebral regions<br /><br>associated with pain. This will be measured by F18-FDG PET-CT scans, which<br /><br>provide information on the (semi-)quantitative uptake of the F18-FDG<br /><br>radiotracer in the brain. This radiotracer is a positron emitting molecule and<br /><br>its chemical structure is very similar to glucose. Thus it acts like an<br /><br>analogue, mimicking distribution patterns of glucose and accumulating in<br /><br>tissues with elevated glucose demand (32). The F18-FDG PET-CT scans will be<br /><br>performed prior to SCS implantation of FBSS patients. Data of FBSS patients<br /><br>will be compared to a readily available database of healthy individuals. </p><br>
- Secondary Outcome Measures
Name Time Method