Post-laminectomy syndrome
Conditions
Interventions
None listed
Sponsors
Radboud Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • 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)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study parameter is metabolic glucose activity of cerebral regions associated with pain. This will be measured by F18-FDG PET-CT scans, which provide information on the (semi-)quantitative uptake of the F18-FDG radiotracer in the brain. This radiotracer is a positron emitting molecule and its chemical structure is very similar to glucose. Thus it acts like an analogue, mimicking distribution patterns of glucose and accumulating in tissues with elevated glucose demand (32). The F18-FDG PET-CT scans will be performed prior to SCS implantation of FBSS patients. Data of FBSS patients will be compared to a readily available database of healthy individuals. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary parameter of this study is SCS outcome. This will be determined by questionnaires which explore pain experience, interference of pain with daily life and overall quality of life prior to SCS implantation and at set follow-up moments of 1, 3 and 6 months post SCS implantation. The Dutch version of the brief pain inventory (BPI) will be used to explore pain experience and interference of pain with daily life. Quality of life will be assessed by use of the EQ5D. These questionnaires are provided in file F1. Additionally, potential complications of SCS will be monitored. Baseline characteristics and patient specific history of all patients will be examined to ensure a complete overview of the studied population can be provided. Baseline characteristics of patients will include gender, age, height, weight and BMI. These baseline characteristics are also necessary for adequate PET-CT imaging and dose administration. Patient specific history will include information on comorbidities, FBSS treatment and history (e.g., years suffered from FBSS, the type and amount of spinal surgeries, treatments, therapies and an extensive assessment of pain medication). Comorbidities that could interfere with PET-CT validity will be established prior to inclusion and will prevent patients from participating in the study. | — |
Countries
Netherlands
Outcome results
None listed