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Completed

NCT Number: NCT04121104

Electrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation

This study is investigating skin conductance and respiration during on and off states of the spinal cord stimulator, in patients 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

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel, Jette, Brussels Capital, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subject is at least 18 years old.
  • 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.
  • Cognitive and language functioning enabling coherent communication between the examiner and the participant.

Exclusion criteria

  • Patients with impaired skin integrity at the fingers.
  • Patients with major psychiatric problems.

Treatment and study plan

SCS is switched off

Other

Spinal cord stimulator is switched off for 12 hours

SCS is switched on

Other

Spinal cord stimulator is on

Primary outcomes

  1. Skin conductance 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 skin conductance between both measurements (SCS on versus SCS off)

  2. Respiration rate

    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 respiration rate between both measurements (SCS on versus SCS off)

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

Moens Maarten

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 9, 2019
Registry last updated
Mar 3, 2020

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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