AdaptiveStim Objectifying Subjective Pain Questionnaires

Failed Back Surgery Syndrome Clinical Trial

— EMINENT  

Official title:

AdaptiveStim Objectifying Subjective Pain Questionnaires

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02974101
• Other study ID #: EMINENT1
• Status: Completed
• Phase: N/A
• First received: November 22, 2016
• Last updated: July 12, 2017
• Start date: November 2016
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Failed Back Surgery Syndrome

Intervention

Other:
• registration of AdaptiveStim

Locations

Country	Name	City	State
Belgium	UZ Brussel	Brussels	Vlaams Brabant
Belgium	AZ Nikolaas	Sint-Niklaas	Oost-Vlaanderen

Sponsors (2)

Lead Sponsor	Collaborator
Moens Maarten	Medtronic

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AdaptiveStim output	The Implantable Pulse Generator contains a processor and accelerometer to record objective information about 7 functional positions.	The change between baseline (T1) and the second assessment 7 days later (T1+7days)
Primary	Disability	Disability will be measured using the Oswestry Disability Index (ODI) questionnaire	Disability will be measured at the second assessment namely 7 days after the first assessment
Secondary	Numeric Rating Scale (NRS) pain diary		Three times every day (morning, afternoon and evening), during 7 days (from baseline assessment (T1) to second assessment (T1+7days))
Secondary	Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics).	This compact and lightweight electronic device similar in size to a wristwatch is worn on the non-dominant hand, and measures and records sleep quality	Three times every day (morning, afternoon and evening), during 7 days (from baseline assessment (T1) to second assessment (T1+7days))
Secondary	Subjective sleep quality	Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).	Disability will be measured at the second assessment namely 7 days after the first assessment