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Completed

NCT Number: NCT02974101

AdaptiveStim Objectifying Subjective Pain Questionnaires

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.

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Key information

Conditions

Failed Back Surgery Syndrome Back Pain Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

AZ Nikolaas, Sint-Niklaas, Oost-Vlaanderen, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

registration of AdaptiveStim

Other

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Moens Maarten

Other

Collaborators

  • Medtronic

Registry information

Acronym: EMINENT

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Nov 28, 2016
Registry last updated
Jul 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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