NCT04121104

Brief Summary

This study is investigating skin conductance and respiration 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
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

May 4, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

October 8, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 9, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 25, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2020

Completed
Last Updated

March 3, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

May 4, 2019

Last Update Submit

March 2, 2020

Conditions

Failed Back Surgery Syndrome

Keywords

Spinal cord stimulationElectrodermal activity

Outcome Measures

Primary Outcomes (2)

  • Skin conductance changes

    The investigators will examine the difference in skin conductance 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.]

  • Respiration rate

    The investigators will examine the difference in respiration rate 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 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
Other: SCS is switched off

SCS on

EXPERIMENTAL
Other: SCS is switched on

Interventions

SCS is switched offOTHER

Spinal cord stimulator is switched off for 12 hours

SCS off
SCS is switched onOTHER

Spinal cord stimulator is on

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 impaired skin integrity at the fingers.
  • Patients with major psychiatric problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

Location

Clinique Ste Elisabeth

Verviers, 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
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 4, 2019

First Posted

October 9, 2019

Study Start

October 8, 2019

Primary Completion

January 25, 2020

Study Completion

January 25, 2020

Last Updated

March 3, 2020

Record last verified: 2020-03

Locations

BE(2)