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

Failed Back Surgery Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04668482
• Other study ID #: SWEAT2
• Status: Completed
• Phase: N/A
• Start date: December 12, 2020
• Est. completion date: December 12, 2020

Study information

• Verified date: January 2021
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 12, 2020
• Est. primary completion date: December 12, 2020
• 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:

• Patients with major psychiatric problems.

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The change between the measurement while SCS is switched off and while SCS is switched on. Total study duration lasts one day.
Secondary	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.	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.