Back to resultsHRV 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, Heart rate variability
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:
- The presence of one or more coexisting conditions known to affect HRV analysis (including but not limited to atrial fibrillation, numerous atrial or ventricular extra beats, paced rhythm, left ventricular bundle branch block, cancer, kidney or hepatic failure, and diabetes mellitus (autonomic nervous system dysfunction)).
- The use of medication that directly modifies autonomic control (for example beta-blockers).
Sites / Locations
- UZ Brussel
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
SCS off
SCS on
Arm Description
Outcomes
Primary Outcome Measures
Heart rate variability changes
The investigators will examine the difference in heart rate variability between both measurements (SCS on versus SCS off)
Secondary Outcome Measures
Pain intensity scores
Pain intensity scores on a visual analogue scale ranging from zero (no pain) towards 10 (worst possible pain).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03768791
Brief Title
HRV in Patients Treated With Spinal Cord Stimulation
Official Title
Heart Rate Variability in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
December 21, 2018 (Actual)
Study Completion Date
December 21, 2018 (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 an observatory single center study investigating heart rate variability 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, Heart rate variability
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (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
Heart rate variability changes
Description
The investigators will examine the difference in heart rate variability 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
Description
Pain intensity scores on a visual analogue scale ranging from zero (no pain) towards 10 (worst possible pain).
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:
The presence of one or more coexisting conditions known to affect HRV analysis (including but not limited to atrial fibrillation, numerous atrial or ventricular extra beats, paced rhythm, left ventricular bundle branch block, cancer, kidney or hepatic failure, and diabetes mellitus (autonomic nervous system dysfunction)).
The use of medication that directly modifies autonomic control (for example beta-blockers).
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
UZ Brussel
City
Jette
State/Province
Brussel
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
23750425
Citation
Kalmar Z, Kovacs N, Balas I, Perlaki G, Plozer E, Orsi G, Altbacker A, Schwarcz A, Hejjel L, Komoly S, Janszky J. Effects of spinal cord stimulation on heart rate variability in patients with chronic pain. Ideggyogy Sz. 2013 Mar 30;66(3-4):102-6.
Results Reference
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Learn more about this trial
HRV in Patients Treated With Spinal Cord Stimulation
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