NCT02974101

AdaptiveStim Objectifying Subjective Pain Questionnaires

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 39 (actual)
• Sponsor: Moens Maarten · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Failed Back Surgery Syndrome

Interventions

Type	Name	Description
OTHER	registration of AdaptiveStim

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-05-01
• Completion: 2017-06-01
• First posted: 2016-11-28
• Last updated: 2017-07-13

Locations

2 sites across 1 country: Belgium