HRV in Patients Treated With Spinal Cord Stimulation

Heart Rate Variability in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03768791

Enrollment

Registered

2018-12-07

Start date

2018-12-01

Completion date

2018-12-21

Last updated

2019-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Failed Back Surgery Syndrome

Keywords

Spinal Cord Stimulation, Heart rate variability

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.

Interventions

OTHERSCS is switched off

Spinal cord stimulator is switched off for 12 hours

OTHERSCS is switched on

Spinal cord stimulator is on

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
Heart rate variability 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 heart rate variability between both measurements (SCS on versus SCS off)

Secondary

Measure	Time frame	Description
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.	Pain intensity scores on a visual analogue scale ranging from zero (no pain) towards 10 (worst possible pain).

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026