Back to resultsElectrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation
Primary Purpose
Failed Back Surgery Syndrome
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
SCS is switched off
SCS is switched on
Sponsored by
About this trial
This is an interventional basic science trial for Failed Back Surgery Syndrome focused on measuring Spinal cord stimulation, Electrodermal activity
Eligibility Criteria
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.
Sites / Locations
- Universitair Ziekenhuis Brussel
- Clinique Ste Elisabeth
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SCS off
SCS on
Arm Description
Outcomes
Primary Outcome Measures
Skin conductance changes
The investigators will examine the difference in skin conductance between both measurements (SCS on versus SCS off)
Respiration rate
The investigators will examine the difference in respiration rate between both measurements (SCS on versus SCS off)
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04121104
Brief Title
Electrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation
Official Title
Electrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
October 8, 2019 (Actual)
Primary Completion Date
January 25, 2020 (Actual)
Study Completion Date
January 25, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Moens Maarten
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Back Surgery Syndrome
Keywords
Spinal cord stimulation, Electrodermal activity
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SCS off
Arm Type
Experimental
Arm Title
SCS on
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
SCS is switched off
Intervention Description
Spinal cord stimulator is switched off for 12 hours
Intervention Type
Other
Intervention Name(s)
SCS is switched on
Intervention Description
Spinal cord stimulator is on
Primary Outcome Measure Information:
Title
Skin conductance changes
Description
The investigators will examine the difference in skin conductance between both measurements (SCS on versus SCS off)
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.]
Title
Respiration rate
Description
The investigators will examine the difference in respiration rate between both measurements (SCS on versus SCS off)
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.]
Secondary Outcome Measure Information:
Title
Pain intensity scores using the Visual Analogue Scale
Description
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.
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.]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maarten Moens, Prof. dr.
Organizational Affiliation
Universitair Ziekenhuis Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Jette
State/Province
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Clinique Ste Elisabeth
City
Verviers
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Electrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation
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