Failed Back Surgery SyndromeEMINENTNCT02974101
AdaptiveStim Objectifying Subjective Pain Questionnaires
A study testing registration of AdaptiveStim in people with Failed Back Surgery Syndrome, run by Moens Maarten at 2 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome
- What is being tested?
- registration of AdaptiveStim
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesBelgium
- Study dates
- Nov 2016to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Patients with Parkinson's disease
- Patients immobilised due to limb/pelvis/costal fractures
- Stroke patients with MRS>3
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
UZ Brussel
Brussels, Vlaams Brabant, 1090
AZ Nikolaas
Sint-Niklaas, Oost-Vlaanderen, 9100
About this study
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.
Read the 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.
- Conditions
- Failed Back Surgery Syndrome
- Being tested
- registration of AdaptiveStim
- Keywords
- Spinal cord stimulation, AdaptiveStim
- Medical subject headings
- Failed Back Surgery Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
registration of AdaptiveStimOther
| Study group | Role | What they receive |
|---|---|---|
| spinal cord stimulation(RestoreSensor) | Experimental | Not described Receives: Other: registration of AdaptiveStim |
What is being measured
The primary outcome is the main question the study is designed to answer.
AdaptiveStim output
The Implantable Pulse Generator contains a processor and accelerometer to record objective information about 7 functional positions.
Measured: 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
Measured: Disability will be measured at the second assessment namely 7 days after the first assessment
Secondary outcomes (3)
Numeric Rating Scale (NRS) pain diary
Measured: 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).
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
Measured: Three times every day (morning, afternoon and evening), during 7 days (from baseline assessment (T1) to second assessment (T1+7days))
Subjective sleep quality
Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).
Measured: Disability will be measured at the second assessment namely 7 days after the first assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2016 (estimated)
- Study startNov 2016
- Primary completionMay 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Back Surgery SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Moens Maarten
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor-investigator, Moens Maarten, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02974101
- Sponsor's protocol ID
- EMINENT1
- Acronym
- EMINENT
- Status last verified
- Jul 2017
- First submitted
- 22 Nov 2016
- Last updated
- 13 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AdaptiveStim Objectifying Subjective Pain Questionnaires
- ClinicalTrials.gov ID
- NCT02974101
- Acronym / sponsor ID
- EMINENT / EMINENT1
- Conditions
- Failed Back Surgery Syndrome
- Keywords
- Spinal cord stimulation, AdaptiveStim
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Moens MaartenUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Nov 2016
- Primary completion
- May 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 28 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spinal cord stimulation(RestoreSensor) | Experimental | Other: registration of AdaptiveStim |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with Parkinson's disease
- Patients immobilised due to limb/pelvis/costal fractures
- Stroke patients with MRS>3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| registration of AdaptiveStim | Other | spinal cord stimulation(RestoreSensor) |
Primary outcome
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
3 secondary outcomes
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))
Subjective sleep quality
Time frame: Disability will be measured at the second assessment namely 7 days after the first assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2017.
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Failed Back Surgery Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing registration of AdaptiveStim in people with Failed Back Surgery Syndrome, run by Moens Maarten at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AdaptiveStim output (time frame: The change between baseline (T1) and the second assessment 7 days later (T1+7days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2017.