Back to resultsEvaluating a Treatment Effect in Patients With FBSS Using an Electronic Nose: a Pilot Study (NOSE)
Primary Purpose
Failed Back Surgery Syndrome
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
SCS is switched off
SCS is switched on
Sponsored by
About this trial
This is an interventional basic science trial for Failed Back Surgery Syndrome
Eligibility Criteria
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.
Sites / Locations
- Universitair Ziekenhuis Brussel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SCS off
SCS on
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04469738
First Posted
July 9, 2020
Last Updated
May 20, 2021
Sponsor
Universitair Ziekenhuis Brussel
Collaborators
the eNose company
1. Study Identification
Unique Protocol Identification Number
NCT04469738
Brief Title
Evaluating a Treatment Effect in Patients With FBSS Using an Electronic Nose: a Pilot Study
Acronym
NOSE
Official Title
Evaluating a Treatment Effect in Patients With FBSS Using an Electronic Nose: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
December 12, 2020 (Actual)
Primary Completion Date
March 27, 2021 (Actual)
Study Completion Date
March 27, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel
Collaborators
the eNose company
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Back Surgery Syndrome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SCS off
Arm Type
Experimental
Arm Title
SCS on
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
SCS is switched off
Intervention Description
Spinal cord stimulator is switched off for 12 hours
Intervention Type
Device
Intervention Name(s)
SCS is switched on
Intervention Description
Spinal cord stimulator is functioning
Primary Outcome Measure Information:
Title
Exhaled breath changes
Description
The investigators will examine the difference in exhaled breath patterns between both measurements (SCS on versus SCS off), measured with the Aeonose.
Time Frame
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 Outcome Measure Information:
Title
Pain intensity scores using the Visual Analogue Scale
Description
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.
Time Frame
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.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maarten Moens, Prof. dr.
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Jette
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Evaluating a Treatment Effect in Patients With FBSS Using an Electronic Nose: a Pilot Study
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