AdaptiveStim Objectifying Subjective Pain Questionnaires

Moens Maarten39 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Failed Back Surgery Syndrome

Interventions

registration of AdaptiveStimOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

AZ Nikolaas

Sint-Niklaas, Oost-Vlaanderen, Belgium

UZ Brussel

Brussels, Vlaams Brabant, Belgium

Outcomes

Primary Outcomes

AdaptiveStim output

The Implantable Pulse Generator contains a processor and accelerometer to record objective information about 7 functional positions.

Time frame: The change between baseline (T1) and the second assessment 7 days later (T1+7days)

Disability

Disability will be measured using the Oswestry Disability Index (ODI) questionnaire

Time frame: Disability will be measured at the second assessment namely 7 days after the first assessment

Secondary Outcomes

Numeric Rating Scale (NRS) pain diary

Time frame: 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).

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

Time frame: Three times every day (morning, afternoon and evening), during 7 days (from baseline assessment (T1) to second assessment (T1+7days))

Subjective sleep quality

Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).

Time frame: Disability will be measured at the second assessment namely 7 days after the first assessment

Data from ClinicalTrials.gov

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