AdaptiveStim Objectifying Subjective Pain Questionnaires

Not Applicable

Completed

• Conditions: Failed Back Surgery Syndrome
• Interventions: Other: registration of AdaptiveStim

• Registration Number: NCT02974101
• Lead Sponsor: Moens Maarten

Brief 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.

Study Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-11-22
• Study First Submitted QC: 2016-11-25
• Study First Posted: 2016-11-28
• Primary Completion: 2017-05
• Study Completion: 2017-06
• Status Verified: 2017-07
• Last Update Submitted: 2017-07-12
• Last Update Posted: 2017-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
spinal cord stimulation(RestoreSensor)	registration of AdaptiveStim	-

Primary Outcome Measures

Name	Time	Method
Disability	Disability will be measured at the second assessment namely 7 days after the first assessment	Disability will be measured using the Oswestry Disability Index (ODI) questionnaire
AdaptiveStim output	The change between baseline (T1) and the second assessment 7 days later (T1+7days)	The Implantable Pulse Generator contains a processor and accelerometer to record objective information about 7 functional positions.

Secondary Outcome Measures

Name	Time	Method
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))
Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics).	Three times every day (morning, afternoon and evening), during 7 days (from baseline assessment (T1) to second assessment (T1+7days))	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
Subjective sleep quality	Disability will be measured at the second assessment namely 7 days after the first assessment	Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).

Trial Locations

Locations (2)

AZ Nikolaas; 🇧🇪 Sint-Niklaas, Oost-Vlaanderen, Belgium

UZ Brussel; 🇧🇪 Brussels, Vlaams Brabant, Belgium