Electrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation

Failed Back Surgery Syndrome Clinical Trial

Official title:

Electrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04121104
• Other study ID #: SWEAT
• Status: Completed
• Phase: N/A
• Start date: October 8, 2019
• Est. completion date: January 25, 2020

Study information

• Verified date: March 2020
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: January 25, 2020
• Est. primary completion date: January 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome

Intervention

Other:
• SCS is switched off
Spinal cord stimulator is switched off for 12 hours
• SCS is switched on
Spinal cord stimulator is on

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussel
Belgium	Clinique Ste Elisabeth	Verviers

Sponsors (1)

Lead Sponsor	Collaborator
Moens Maarten

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Skin conductance changes	The investigators will examine the difference in skin conductance between both measurements (SCS on versus SCS off)	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.]
Primary	Respiration rate	The investigators will examine the difference in respiration rate between both measurements (SCS on versus SCS off)	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	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.]