AdaptiveStim Objectifying Subjective Pain Questionnaires (EMINENT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02974101|
Recruitment Status : Completed
First Posted : November 28, 2016
Last Update Posted : July 13, 2017
|Condition or disease||Intervention/treatment||Phase|
|Failed Back Surgery Syndrome||Other: registration of AdaptiveStim||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||39 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||AdaptiveStim Objectifying Subjective Pain Questionnaires|
|Study Start Date :||November 2016|
|Actual Primary Completion Date :||May 2017|
|Actual Study Completion Date :||June 2017|
|Experimental: spinal cord stimulation(RestoreSensor)||
Other: registration of AdaptiveStim
- AdaptiveStim output [ Time Frame: 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 [ Time Frame: 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
- 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). [ Time Frame: 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 [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02974101
|Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100|
|Brussels, Vlaams Brabant, Belgium, 1090|