MedDataX Logo

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

NCT ID: NCT04668482

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-12

Study Completion Date

2020-12-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Failed Back Surgery Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SCS off

SCS is switched off

Group Type EXPERIMENTAL

SCS is switched off

Intervention Type DEVICE

Spinal cord stimulator is switched off for 12 hours

SCS on

SCS is switched on

Group Type EXPERIMENTAL

SCS is switched on

Intervention Type DEVICE

Spinal cord stimulator is functioning

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SCS is switched off

Spinal cord stimulator is switched off for 12 hours

Intervention Type DEVICE

SCS is switched on

Spinal cord stimulator is functioning

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Moens Maarten

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Maarten Moens, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitair Ziekenhuis Brussel

Jette, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SWEAT2

Identifier Type: -

Identifier Source: org_study_id