Evaluating a Treatment Effect in Patients With FBSS Using an Electronic Nose: a Pilot Study
Not Applicable
Completed
- Conditions
- Failed Back Surgery Syndrome
- Interventions
- Device: SCS is switched offDevice: SCS is switched on
- Registration Number
- NCT04469738
- Lead Sponsor
- Universitair Ziekenhuis Brussel
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 27
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description SCS off SCS is switched off - SCS on SCS is switched on -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
Universitair Ziekenhuis Brussel
🇧🇪Jette, Belgium