Electrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation

Not Applicable

Completed

• Conditions: Failed Back Surgery Syndrome
• Interventions: Other: SCS is switched on; Other: SCS is switched off

• Registration Number: NCT04121104
• Lead Sponsor: Moens Maarten

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-04
• Study Start: 2019-10-08
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-09
• Primary Completion: 2020-01-25
• Study Completion: 2020-01-25
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-02
• Last Update Posted: 2020-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SCS on	SCS is switched on	-
SCS off	SCS is switched off	-

Primary Outcome Measures

Name	Time	Method
Respiration rate	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)
Skin conductance 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 skin conductance between both measurements (SCS on versus SCS off)

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Brussel, Belgium

Clinique Ste Elisabeth; 🇧🇪 Verviers, Belgium