Failed Back Surgery Syndrome
Conditions
Brief summary
This study is investigating sweat gland function during on and off states of the spinal cord stimulator, in patients 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
Universitair Ziekenhuis Brussel
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject is at least 18 years old. * 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. * Cognitive and language functioning enabling coherent communication between the examiner and the participant.
Exclusion criteria
* Patients with major psychiatric problems.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sweat gland function by measuring Electrochemical Skin Conductances (ESC) | The change between the measurement while SCS is switched off and while SCS is switched on. Total study duration lasts one day. | The investigators will examine the difference in sweat gland function between both measurements (SCS on versus SCS off), measured with the Sudoscan. |
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) from zero (no pain) towards 10 cm (worst possible pain) for the pain intensity. |
Countries
Belgium
Outcome results
None listed