Failed Back Surgery Syndrome
Conditions
Brief summary
This study is an experimental single-center pilot study investigating Volatile Organic Compounds patterns in exhaled breath during on and off states of SCS, in patient with Failed Back Surgery Syndrome.
Interventions
DEVICESCS is switched off
Spinal cord stimulator is switched off for 12 hours
DEVICESCS is switched on
Spinal cord stimulator is functioning
Sponsors
the eNose company
Universitair Ziekenhuis Brussel
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of FBSS (Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation.
Exclusion criteria
* Patients with a diagnosis of cancer. * Patients with major psychiatric problems. * Patients with an underlying respiratory disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Exhaled breath changes | Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day. | The investigators will examine the difference in exhaled breath patterns between both measurements (SCS on versus SCS off), measured with the Aeonose. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity scores using the Visual Analogue Scale | Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day. | Pain intensity score on that time on a Visual Analogue Scale (VAS) ranging from zero (no pain) towards 10 (worst possible pain) for the pain intensity. |
Countries
Belgium
Outcome results
None listed