Failed Back Surgery SyndromeDiscoverNCT02787265
High-density in Spinal Cord Stimulation: Virtual Expert Registry
An observational study of Failed Back Surgery Syndrome, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
This is a prospective, multi-center, observational follow-up study observing the effectiveness of high density spinal cord stimulation in patients with failed back surgery syndrome patients with back and leg pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Failed Back Surgery Syndrome
- What is being tested?
- spinal cord stimulation
- Type of treatment
- Medical device
- How many people
- 272 participants
- Where
- 1 siteBelgium
- Study dates
- Jun 2016to 8 Dec 2020
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic back and leg pain (due to Failed Back Surgery Syndrome) who either received SCS or have not sufficient pain reduction with traditional parameters or patients with chronic back and leg pain who are candidate for SCS will receive HD SCS.
Who may be able to join
- Failed Back Surgery Syndrome patients (FBSS) with insufficient pain reduction with conventional SCS or FBSS patients suitable for SCS
- Age > 18 years
- Chronic pain as a result of FBSS that exists for at least 6 months with a pain intensity 5 or higher measured on numeric rating scale (NRS)
- Patient has been informed of the study procedures and has given written informed consent
- Patient willing to comply with study protocol including attending the study visits
Who cannot join
- Expected inability of patients to receive or properly operate the spinal cord stimulation system
- History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
- Active malignancy
- Addiction to any of the following drugs, alcohol (5E/day) and/or medication
- Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
- Immune deficiency (HIV positive, immunosuppressiva, etc.)
Show all 10Show fewer
- Life expectancy < 1 year
- Local infection or other skin disorder at site of incision
- Pregnancy
- Other implanted active medical device
Trial locations and contacts
1 site in 1 country.
About this study
This is a prospective, multi-center, observational follow-up study observing the effectiveness of high density spinal cord stimulation in patients with failed back surgery syndrome patients with back and leg pain.
Read the detailed description
DISCOVER will measure the effectiveness of high-density spinal cord stimulation for treatment of chronic back and leg pain. Identification of clinical effective parameters concerning location of active electrodes, frequency, pulse duration, amplitude and battery consumption are, besides safety, the major outcome parameters of this study.
- Conditions
- Failed Back Surgery Syndrome
- Being tested
- spinal cord stimulation
- Keywords
- High density spinal cord stimulation, Virtual expert registry
- 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.
spinal cord stimulationDevice
Also called high density spinal cord stimulation
| Study group | Role | What they receive |
|---|---|---|
| spinal cord stimulation | Failed back surgery syndrome patients will receive high density spinal cord stimulation Receives: Device: spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity with the Numeric Rating Scale (NRS)
Measured: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Pain relief by pain medication
Questionnaire regarding the amount of pain relief by pain medication
Measured: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
The abilities in daily living
The functional abilities will be assessed with the Oswestry Low Back Pain Questionnaire.
Measured: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
The current health status
The health status will be observed with the Euroqol (EQ-5D-5L) questionnaire.
Measured: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Subjective sleep quality
Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).
Measured: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Patient's satisfaction
Patient's satisfaction with the stimulation will be assessed with a 5 item Likert scale
Measured: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Secondary outcomes (6)
Pain area coverage
The patient has to draw the areas of pain coverage on a body shape figure
Measured: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
Paresthesia threshold
Patient indicates the threshold at which he experiences paresthesia
Measured: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
HD stim parameters
Questionnaire towards the clinician regarding the ideal high density parameters for this patient
Measured: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
Battery efficiency of the neurostimulator
The battery usage will be measured by frequencies to recharge the battery.
Measured: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
AdaptiveStim use (in case of Restore Sensor)
Acquire information on activity from the internal diary; amount of times that patients need to fit the ideal parameters themselves
Measured: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
MRI need
Questionnaire regarding the need for MR scans for other medical conditions
Measured: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion8 Dec 2020
- Study completion8 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 272 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Moens Maarten, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787265
- Sponsor's protocol ID
- Discover1
- Acronym
- Discover
- Status last verified
- Jan 2021
- First submitted
- 26 May 2016
- Last updated
- 1 Feb 2021
- Results posted
- No
Publications
Song Z, Meyerson BA, Linderoth B. High-Frequency (1 kHz) Spinal Cord Stimulation-Is Pulse Shape Crucial for the Efficacy? A Pilot Study. Neuromodulation. 2015 Dec;18(8):714-20. doi: 10.1111/ner.12344. Epub 2015 Sep 6.
PubMed 26344573Sweet J, Badjatiya A, Tan D, Miller J. Paresthesia-Free High-Density Spinal Cord Stimulation for Postlaminectomy Syndrome in a Prescreened Population: A Prospective Case Series. Neuromodulation. 2016 Apr;19(3):260-7. doi: 10.1111/ner.12357. Epub 2015 Oct 20.
PubMed 26481726Goudman L, Rigoard P, Billot M, De Smedt A, Roulaud M, Consortium D, Moens M; Discover Consortium. Spinal Cord Stimulation-Naive Patients vs Patients With Failed Previous Experiences With Standard Spinal Cord Stimulation: Two Distinct Entities or One Population? Neuromodulation. 2023 Jan;26(1):157-163. doi: 10.1016/j.neurom.2022.04.037. Epub 2022 May 10.
PubMed 35551868Goudman L, De Smedt A, Eldabe S, Rigoard P, Linderoth B, De Jaeger M, Moens M; Discover Consortium. High-dose spinal cord stimulation for patients with failed back surgery syndrome: a multicenter effectiveness and prediction study. Pain. 2021 Feb 1;162(2):582-590. doi: 10.1097/j.pain.0000000000002035.
PubMed 32910099
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-density in Spinal Cord Stimulation: Virtual Expert Registry
- ClinicalTrials.gov ID
- NCT02787265
- Acronym / sponsor ID
- Discover / Discover1
- Conditions
- Failed Back Surgery Syndrome
- Keywords
- High density spinal cord stimulation, Virtual expert registry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Jun 2016
- Primary completion
- 8 Dec 2020 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 1 Jun 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, observational follow-up study observing the effectiveness of high density spinal cord stimulation in patients with failed back surgery syndrome patients with back and leg pain.
Detailed description
DISCOVER will measure the effectiveness of high-density spinal cord stimulation for treatment of chronic back and leg pain. Identification of clinical effective parameters concerning location of active electrodes, frequency, pulse duration, amplitude and battery consumption are, besides safety, the major outcome parameters of this study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| spinal cord stimulation | – | Device: spinal cord stimulationFailed back surgery syndrome patients will receive high density spinal cord stimulation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic back and leg pain (due to Failed Back Surgery Syndrome) who either received SCS or have not sufficient pain reduction with traditional parameters or patients with chronic back and leg pain who are candidate for SCS will receive HD SCS.
Key inclusion criteria (5 listed)
- Failed Back Surgery Syndrome patients (FBSS) with insufficient pain reduction with conventional SCS or FBSS patients suitable for SCS
- Age > 18 years
- Chronic pain as a result of FBSS that exists for at least 6 months with a pain intensity 5 or higher measured on numeric rating scale (NRS)
- Patient has been informed of the study procedures and has given written informed consent
- Patient willing to comply with study protocol including attending the study visits
Key exclusion criteria (10 listed)
- Expected inability of patients to receive or properly operate the spinal cord stimulation system
- History of coagulation disorders, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis or morbus Bechterew
- Active malignancy
- Addiction to any of the following drugs, alcohol (5E/day) and/or medication
- Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by investigator
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 |
|---|---|---|
| spinal cord stimulationAlso: high density spinal cord stimulation | Device | spinal cord stimulation |
Primary outcome
Pain intensity with the Numeric Rating Scale (NRS)
Time frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Pain relief by pain medication
Time frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Questionnaire regarding the amount of pain relief by pain medication
The abilities in daily living
Time frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
The functional abilities will be assessed with the Oswestry Low Back Pain Questionnaire.
The current health status
Time frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
The health status will be observed with the Euroqol (EQ-5D-5L) questionnaire.
Subjective sleep quality
Time frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Subjective sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI).
Patient's satisfaction
Time frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
Patient's satisfaction with the stimulation will be assessed with a 5 item Likert scale
6 secondary outcomes
Pain area coverage
Time frame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
Paresthesia threshold
Time frame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
HD stim parameters
Time frame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
Battery efficiency of the neurostimulator
Time frame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
AdaptiveStim use (in case of Restore Sensor)
Time frame: The difference between the evaluation 1 month after high density stimulation, 3 months and 12 months.
MRI need
Time frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.
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 1 Feb 2021.
- Background: PubMed 26344573Song Z, Meyerson BA, Linderoth B. High-Frequency (1 kHz) Spinal Cord Stimulation-Is Pulse Shape Crucial for the Efficacy? A Pilot Study. Neuromodulation. 2015 Dec;18(8):714-20. doi: 10.1111/ner.12344. Epub 2015 Sep 6.
- Background: PubMed 26481726Sweet J, Badjatiya A, Tan D, Miller J. Paresthesia-Free High-Density Spinal Cord Stimulation for Postlaminectomy Syndrome in a Prescreened Population: A Prospective Case Series. Neuromodulation. 2016 Apr;19(3):260-7. doi: 10.1111/ner.12357. Epub 2015 Oct 20.
- Derived from this study: PubMed 35551868Goudman L, Rigoard P, Billot M, De Smedt A, Roulaud M, Consortium D, Moens M; Discover Consortium. Spinal Cord Stimulation-Naive Patients vs Patients With Failed Previous Experiences With Standard Spinal Cord Stimulation: Two Distinct Entities or One Population? Neuromodulation. 2023 Jan;26(1):157-163. doi: 10.1016/j.neurom.2022.04.037. Epub 2022 May 10.
- Derived from this study: PubMed 32910099Goudman L, De Smedt A, Eldabe S, Rigoard P, Linderoth B, De Jaeger M, Moens M; Discover Consortium. High-dose spinal cord stimulation for patients with failed back surgery syndrome: a multicenter effectiveness and prediction study. Pain. 2021 Feb 1;162(2):582-590. doi: 10.1097/j.pain.0000000000002035.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Failed Back Surgery Syndrome, run by Universitair Ziekenhuis Brussel at 1 site 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 5 inclusion and 10 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 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Pain intensity with the Numeric Rating Scale (NRS) (time frame: The difference between the baseline screening and the evaluation 1 month after high density stimulation, 3 months and 12 months.). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02787265, which also lists 4 linked publications.
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 1 Feb 2021.