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AdaptiveStim Objectifying Subjective Pain Questionnaires (EMINENT)

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ClinicalTrials.gov Identifier: NCT02974101
Recruitment Status : Completed
First Posted : November 28, 2016
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Moens Maarten, Universitair Ziekenhuis Brussel

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.

Condition or disease Intervention/treatment Phase
Failed Back Surgery Syndrome Other: registration of AdaptiveStim Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: AdaptiveStim Objectifying Subjective Pain Questionnaires
Study Start Date : November 2016
Actual Primary Completion Date : May 2017
Actual Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: spinal cord stimulation(RestoreSensor) Other: registration of AdaptiveStim



Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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)) ]
  2. 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

  3. 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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
Belgium
AZ Nikolaas
Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
UZ Brussel
Brussels, Vlaams Brabant, Belgium, 1090
Sponsors and Collaborators
Moens Maarten
Medtronic

Responsible Party: Moens Maarten, Prof. dr., Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT02974101     History of Changes
Other Study ID Numbers: EMINENT1
First Posted: November 28, 2016    Key Record Dates
Last Update Posted: July 13, 2017
Last Verified: July 2017

Keywords provided by Moens Maarten, Universitair Ziekenhuis Brussel:
Spinal cord stimulation
AdaptiveStim

Additional relevant MeSH terms:
Failed Back Surgery Syndrome
Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms