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

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.

Study Overview

• Status: Completed
• Conditions: Failed Back Surgery Syndrome
• Intervention / Treatment: Device: SCS is switched off; Device: SCS is switched on

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Jette, Belgium, 1090
    • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SCS off	Device: SCS is switched off; Spinal cord stimulator is switched off for 12 hours
Experimental: SCS on	Device: SCS is switched on; Spinal cord stimulator is functioning

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Collaborators: the eNose company
• Investigators: Principal Investigator: Maarten Moens, Prof. dr., Universitair Ziekenhuis Brussel

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2020
• Primary Completion (Actual): March 27, 2021
• Study Completion (Actual): March 27, 2021

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): May 21, 2021
• Last Update Submitted That Met QC Criteria: May 20, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Back Pain; Failed Back Surgery Syndrome
• Other Study ID Numbers: NOSE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No