Electrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation

Moens Maarten

Status: Completed

Conditions: Failed Back Surgery Syndrome

Treatments: Other: SCS is switched off; Other: SCS is switched on

Study type: Interventional

Funder types: Other

Identifiers

NCT04121104

SWEAT

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

SCS off

Experimental group

Treatment:

Other: SCS is switched off

SCS on

Experimental group

Treatment:

Other: SCS is switched on