Status:
COMPLETED
HRV in Patients Treated With Spinal Cord Stimulation
Lead Sponsor:
Moens Maarten
Conditions:
Failed Back Surgery Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
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.
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
December 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2018
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03768791
Start Date
December 1 2018
End Date
December 21 2018
Last Update
June 18 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UZ Brussel
Jette, Brussels Capital, Belgium, 1090