Sweat Gland Function in Patients With Failed Back Surgery Syndrome, Treated With Spinal Cord Stimulation

Not Applicable

Completed

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

• Registration Number: NCT04668482
• Lead Sponsor: Universitair Ziekenhuis Brussel

Brief Summary

This study is investigating sweat gland function 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: 2020-12-02
• Study First Submitted QC: 2020-12-08
• Study Start: 2020-12-12
• Primary Completion: 2020-12-12
• Study Completion: 2020-12-12
• Study First Posted: 2020-12-16
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-27
• Last Update Posted: 2021-01-29

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

• Patients with major psychiatric problems.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Sweat gland function by measuring Electrochemical Skin Conductances (ESC)	The change between the measurement while SCS is switched off and while SCS is switched on. Total study duration lasts one day.	The investigators will examine the difference in sweat gland function between both measurements (SCS on versus SCS off), measured with the Sudoscan.

Secondary Outcome Measures

Name	Time	Method
Pain intensity scores using the Visual Analogue Scale	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 score on that time on a Visual Analogue Scale (VAS) from zero (no pain) towards 10 cm (worst possible pain) for the pain intensity.

Trial Locations

Locations (1)

Universitair Ziekenhuis Brussel; 🇧🇪 Jette, Belgium