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Completed

NCT Number: NCT04469738

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

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.

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Key information

Conditions

Failed Back Surgery Syndrome Back Pain Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SCS is switched off

Device

Spinal cord stimulator is switched off for 12 hours

SCS is switched on

Device

Spinal cord stimulator is functioning

Primary outcomes

  1. Exhaled breath changes

    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.

    The investigators will examine the difference in exhaled breath patterns between both measurements (SCS on versus SCS off), measured with the Aeonose.

Secondary outcomes

  1. Pain intensity scores using the Visual Analogue Scale

    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.

    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.

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Collaborators

  • The eNose Company

Registry information

Acronym: NOSE

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 14, 2020
Registry last updated
May 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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