NCT02974101

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 28, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

6 months

First QC Date

November 22, 2016

Last Update Submit

July 12, 2017

Conditions

Failed Back Surgery Syndrome

Keywords

Spinal cord stimulationAdaptiveStim

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (3)

  • 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).

    Three times every day (morning, afternoon and evening), during 7 days (from baseline assessment (T1) to second assessment (T1+7days))

  • Subjective sleep quality

    Disability will be measured at the second assessment namely 7 days after the first assessment

Study Arms (1)

spinal cord stimulation(RestoreSensor)

EXPERIMENTAL
Other: registration of AdaptiveStim

Interventions

registration of AdaptiveStimOTHER
spinal cord stimulation(RestoreSensor)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with Parkinson's disease
  • Patients immobilised due to limb/pelvis/costal fractures
  • Stroke patients with MRS\>3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AZ Nikolaas

Sint-Niklaas, Oost-Vlaanderen, 9100, Belgium

Location

UZ Brussel

Brussels, Vlaams Brabant, 1090, Belgium

Location

MeSH Terms

Conditions

Failed Back Surgery Syndrome

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsBack PainPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. dr.

Study Record Dates

First Submitted

November 22, 2016

First Posted

November 28, 2016

Study Start

November 1, 2016

Primary Completion

May 1, 2017

Study Completion

June 1, 2017

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

BE(2)