HRV in Patients Treated With Spinal Cord Stimulation

Failed Back Surgery Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03768791
• Other study ID #: SYNCHRO
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 21, 2018

Study information

• Verified date: June 2019
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 21, 2018
• Est. primary completion date: December 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome
• Syndrome

Intervention

Other:
• SCS is switched off
Spinal cord stimulator is switched off for 12 hours
• SCS is switched on
Spinal cord stimulator is on

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Moens Maarten

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Kalmár Z, Kovács N, Balás I, Perlaki G, Plózer E, Orsi G, Altbacker A, Schwarcz A, Hejjel L, Komoly S, Janszky J. Effects of spinal cord stimulation on heart rate variability in patients with chronic pain. Ideggyogy Sz. 2013 Mar 30;66(3-4):102-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability changes	The investigators will examine the difference in heart rate variability between both measurements (SCS on versus SCS off)	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.
Secondary	Pain intensity scores	Pain intensity scores on a visual analogue scale ranging from zero (no pain) towards 10 (worst possible pain).	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.