HRV in Patients Treated With Spinal Cord Stimulation

Not Applicable

Completed

• Conditions: Failed Back Surgery Syndrome
• Interventions: Other: SCS is switched off; Other: SCS is switched on

• Registration Number: NCT03768791
• Lead Sponsor: Moens Maarten

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-28
• Study Start: 2018-12-01
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-07
• Primary Completion: 2018-12-21
• Study Completion: 2018-12-21
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-17
• Last Update Posted: 2019-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SCS off	SCS is switched off	-
SCS on	SCS is switched on	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Jette, Brussel, Belgium