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

Universitair Ziekenhuis Brussel

Status: Completed

Conditions: Failed Back Surgery Syndrome

Treatments: Device: SCS is switched off; Device: SCS is switched on

Study type: Interventional

Funder types: Other

Identifiers

NCT04469738

NOSE

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

SCS off

Experimental group

Treatment:

Device: SCS is switched off

SCS on

Experimental group

Treatment:

Device: SCS is switched on