AdaptiveStim Objectifying Subjective Pain Questionnaires (EMINENT)

Moens Maarten

Status: Completed

Conditions: Failed Back Surgery Syndrome

Treatments: Other: registration of AdaptiveStim

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02974101

EMINENT1

Details and patient eligibility

About

This is a prospective, multi-center, correlation study in which the investigators aim to explore the relationship between subjective pain questionnaires and the AdaptiveStim accelerometer output.

Full description

The aim of this research is to gather the necessary information relating to the patient his subjective self-report and the more objective information from the implanted IPG (RestoreSensor). Such subjective information can be gathered from the AdaptivStim output.

The main focus of this study is to explore the relationship between the subjective reporting of functional disability with the ODI, sleep quality with the Actiwatch and PSQI, pain intensity with the NRS-diary and the objective measurement of functional positions with the AdaptiveStim in patients receiving high density spinal cord stimulation.

Enrollment: 39 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• FBSS patients treated with SCS (IPG = RestoreSensor) who achieved a steady state (steady state is considered when the parameters didn't changed for at least one month)
• Age > 18 years

Exclusion criteria

• Patients with Parkinson's disease
• Patients immobilised due to limb/pelvis/costal fractures
• Stroke patients with MRS>3

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

spinal cord stimulation(RestoreSensor)

Experimental group

Treatment:

Other: registration of AdaptiveStim