AdaptiveStim Objectifying Subjective Pain Questionnaires

Study Overview
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Brief Summary
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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
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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.

Official Title
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AdaptiveStim Objectifying Subjective Pain Questionnaires

Conditions
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Failed Back Surgery Syndrome

Intervention / Treatment
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* Other: registration of AdaptiveStim


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: spinal cord stimulation(RestoreSensor)<br> | Other: registration of AdaptiveStim<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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)) | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal cord stimulation, AdaptiveStim