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

• Sponsor: Universitair Ziekenhuis Brussel (Other)
• Overall Status: Completed
• CT.gov ID: NCT04469738
• Collaborator: the eNose company (Other)
• Enrollment: 27
• Location: 1
• Arms: 2
• Actual Duration (Months): 3.4
• Patients Per Site Per Month: 7.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Failed Back Surgery Syndrome	Device: SCS is switched off; Device: SCS is switched on	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 27 participants
• Allocation: Non-Randomized
• Intervention Model: Sequential Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Evaluating a Treatment Effect in Patients With FBSS Using an Electronic Nose: a Pilot Study
• Actual Study Start Date: Dec 12, 2020
• Actual Primary Completion Date: Mar 27, 2021
• Actual Study Completion Date: Mar 27, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitair Ziekenhuis Brussel	Jette		Belgium	1090

Sponsors and Collaborators

• Universitair Ziekenhuis Brussel
• the eNose company

Investigators

• Principal Investigator: Maarten Moens, Prof. dr., Universitair Ziekenhuis Brussel

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Moens Maarten, principal investigator, Universitair Ziekenhuis Brussel
• ClinicalTrials.gov Identifier: NCT04469738
• Other Study ID Numbers: NOSE
• First Posted: Jul 14, 2020
• Last Update Posted: May 21, 2021
• Last Verified: May 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Failed Back Surgery Syndrome

Study Results

No Results Posted as of May 21, 2021