Skip to main content
OpenTrials
Completed

NCT Number: NCT03768791

HRV in Patients Treated With Spinal Cord Stimulation

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Failed Back Surgery Syndrome Back Pain Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

SCS is switched off

Other

Spinal cord stimulator is switched off for 12 hours

SCS is switched on

Other

Spinal cord stimulator is on

Primary outcomes

  1. 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

  1. Pain intensity scores

    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.

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

Sponsors and collaborators

Lead sponsor

Moens Maarten

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Dec 7, 2018
Registry last updated
Jun 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.