NCT04668482

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

December 12, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 16, 2020

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

Same day

First QC Date

December 2, 2020

Last Update Submit

January 27, 2021

Conditions

Failed Back Surgery Syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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.

Study Arms (2)

SCS off

EXPERIMENTAL

SCS is switched off

Device: SCS is switched off

SCS on

EXPERIMENTAL

SCS is switched on

Device: SCS is switched on

Interventions

SCS is switched offDEVICE

Spinal cord stimulator is switched off for 12 hours

SCS off
SCS is switched onDEVICE

Spinal cord stimulator is functioning

SCS on

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients with major psychiatric problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitair Ziekenhuis Brussel

Jette, 1090, Belgium

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsBack PainPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Maarten Moens, Prof. dr.

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

December 2, 2020

First Posted

December 16, 2020

Study Start

December 12, 2020

Primary Completion

December 12, 2020

Study Completion

December 12, 2020

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations

BE(1)