Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| spinal cord stimulation(RestoreSensor) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| registration of AdaptiveStim | Other |
|
| 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 |
| 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). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Nikolaas | Sint-Niklaas | Oost-Vlaanderen | 9100 | Belgium | ||
| UZ Brussel |
Not provided
| ID | Term |
|---|---|
| D055111 | Failed Back Surgery Syndrome |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Brussels |
| Vlaams Brabant |
| 1090 |
| Belgium |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |