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

Universitair Ziekenhuis Brussel23 enrolled

Overview

This study is investigating sweat gland function during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Failed Back Surgery Syndrome

Interventions

SCS is switched offDEVICE

Spinal cord stimulator is switched off for 12 hours

SCS is switched onDEVICE

Spinal cord stimulator is functioning

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Universitair Ziekenhuis Brussel

Jette, Belgium

Outcomes

Primary Outcomes

Sweat gland function by measuring Electrochemical Skin Conductances (ESC)

The investigators will examine the difference in sweat gland function between both measurements (SCS on versus SCS off), measured with the Sudoscan.

Time frame: The change between the measurement while SCS is switched off and while SCS is switched on. Total study duration lasts one day.

Secondary Outcomes

Pain intensity scores using the Visual Analogue Scale

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.

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.

Data from ClinicalTrials.gov

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