Failed Back Surgery Syndrome
Conditions
Keywords
Spinal cord stimulation, AdaptiveStim
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.
Interventions
OTHERregistration of AdaptiveStim
Sponsors
Medtronic
Moens Maarten
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Belgium
Outcome results
None listed