Evaluating a Treatment Effect in Patients With FBSS Using an Electronic Nose: a Pilot Study

Failed Back Surgery Syndrome Clinical Trial

— NOSE  

Official title:

Evaluating a Treatment Effect in Patients With FBSS Using an Electronic Nose: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04469738
• Other study ID #: NOSE
• Status: Completed
• Phase: N/A
• Start date: December 12, 2020
• Est. completion date: March 27, 2021

Study information

• Verified date: May 2021
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: March 27, 2021
• Est. primary completion date: March 27, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome

Intervention

Device:
• SCS is switched off
Spinal cord stimulator is switched off for 12 hours
• SCS is switched on
Spinal cord stimulator is functioning

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette

Sponsors (2)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel	the eNose company

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exhaled breath changes	The investigators will examine the difference in exhaled breath patterns between both measurements (SCS on versus SCS off), measured with the Aeonose.	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.
Secondary	Pain intensity scores using the Visual Analogue Scale	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.	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.