NCT03768791CompletedNot Applicable
Heart Rate Variability in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Moens Maarten
- Enrollment
- 23
- Locations
- 2
- Primary Endpoint
- Heart rate variability changes
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
SCS off
Experimental
Intervention: SCS is switched off (Other)
SCS on
Experimental
Intervention: SCS is switched on (Other)
Outcomes
Primary Outcomes
Heart rate variability 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 heart rate variability between both measurements (SCS on versus SCS off)
Secondary Outcomes
- Pain intensity scores(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.)
Investigators
Moens Maarten
principal investigator
Universitair Ziekenhuis Brussel
Study Sites (2)
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