Back to resultsAdaptiveStim Objectifying Subjective Pain Questionnaires (EMINENT)
Primary Purpose
Failed Back Surgery Syndrome
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
registration of AdaptiveStim
Sponsored by
About this trial
This is an interventional treatment trial for Failed Back Surgery Syndrome focused on measuring Spinal cord stimulation, AdaptiveStim
Eligibility Criteria
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
Sites / Locations
- AZ Nikolaas
- UZ Brussel
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
spinal cord stimulation(RestoreSensor)
Arm Description
Outcomes
Primary Outcome Measures
AdaptiveStim output
The Implantable Pulse Generator contains a processor and accelerometer to record objective information about 7 functional positions.
Disability
Disability will be measured using the Oswestry Disability Index (ODI) questionnaire
Secondary Outcome Measures
Numeric Rating Scale (NRS) pain diary
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
Subjective sleep quality
Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).
Full Information
NCT ID
NCT02974101
First Posted
November 22, 2016
Last Updated
July 12, 2017
Sponsor
Moens Maarten
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT02974101
Brief Title
AdaptiveStim Objectifying Subjective Pain Questionnaires
Acronym
EMINENT
Official Title
AdaptiveStim Objectifying Subjective Pain Questionnaires
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Moens Maarten
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Failed Back Surgery Syndrome
Keywords
Spinal cord stimulation, AdaptiveStim
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
spinal cord stimulation(RestoreSensor)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
registration of AdaptiveStim
Primary Outcome Measure Information:
Title
AdaptiveStim output
Description
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)
Title
Disability
Description
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 Outcome Measure Information:
Title
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))
Title
Objective sleep quality will be measured using the Actiwatch spectrum plus (Respironics).
Description
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))
Title
Subjective sleep quality
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
AZ Nikolaas
City
Sint-Niklaas
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9100
Country
Belgium
Facility Name
UZ Brussel
City
Brussels
State/Province
Vlaams Brabant
ZIP/Postal Code
1090
Country
Belgium
12. IPD Sharing Statement
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AdaptiveStim Objectifying Subjective Pain Questionnaires
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