Failed Back Surgery SyndromeDETECTNCT05068011
Differential Target Multiplexed Spinal Cord Stimulation
An observational study of Failed Back Surgery Syndrome and Persistent Spinal Pain Syndrome Type 2, run by Moens Maarten at 14 sites in Belgium.
Trial summary
Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of chronic back and leg pain. Additionally, a subgroup analysis will be performed to evaluate potential differences between paddle/surgical leads versus percutaneous leads. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Failed Back Surgery Syndrome, Persistent Spinal Pain Syndrome Type 2
- What is being tested?
- Spinal Cord Stimulation
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 14 sitesBelgium
- Study dates
- 6 Oct 2021to Aug 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic back and leg pain due to Failed Back Surgery Syndrome (FBSS)/Persistent Spinal Pain Syndrome type 2 (PSPS-T2), who will receive treatment with differential target multiplexed (DTM) SCS.
Who may be able to join
- Patients with severe chronic pain (> 5 on numeric rating scale, NRS) for at least 6 months due to FBSS (PSPS T2) and suitable for treatment with DTM SCS according to the treating physician
- Age > 18 years
- 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 the patient to receive or properly operate the spinal cord stimulation system
- History of coagulation disorder, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis, or morbus Bechterew
- Active malignancy
- Addiction to drugs, alcohol (>5 units per day) and/or medication
- Evidence of an active disruptive psychiatric disorder or other known condition that may impact perception of pain, compliance to the intervention, and/or ability to evaluate treatment outcome as determined by investigator
- Immune deficiency (e.g. HIV positive, immunosuppressive treatment)
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- Life expectancy < 1 year
- Local infection or any other skin disorder at site of incision
- Pregnancy
- Other implanted active medical device
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Belgium14 sites, 14 recruiting
- Recruiting
ZNA
Antwerp
Michel Turlot, MD
- Recruiting
AZ Sint-Jan Brugge-Oostende
Bruges
Mayken Gorissen, MD
- Recruiting
AZ Sint-Lucas Brugge
Bruges
Mayken Gorissen, MD
- Recruiting
Jessa Ziekenhuis
Hasselt
Mark Plazier, MD, PhD
- Recruiting
Universitair Ziekenhuis Brussel
Jette, Brussels Capital, 1090
Maarten Moens, prof. dr., +3224775514, maarten.moens@uzbrussel.be
Lisa Goudman, PhD, +3224775514, lisa.goudman@gmail.com
- Recruiting
AZ Groeninge
Kortrijk
Pieter-Jan Germonpre, MD
- Recruiting
UZ Leuven
Leuven
Tom Theys, MD, PhD
- Recruiting
Centre Hospitalier Régional (CHR) de la Citadelle
Liège
Thibault Remacle, MD, PhD
- Recruiting
Heilig Hart Ziekenhuis Lier
Lier
Sofie Denkens, MD
- Recruiting
AZ Sint-Maarten
Mechelen
Johan Vangeneugden, MD
- Recruiting
AZ Delta
Roeselare
Bart Billet, MD
- Recruiting
Vitaz
Sint-Niklaas
Jean-Pierre Van Buyten, MD, PhD
- Recruiting
AZ Turnhout
Turnhout
Bart Bryon, MD
- Recruiting
GZA
Wilrijk
Raf Van Paesschen, MD
About this study
Official title: Differential Target Multiplexed Spinal Cord Stimulation: a Multicenter Cohort Study
Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of chronic back and leg pain. Additionally, a subgroup analysis will be performed to evaluate potential differences between paddle/surgical leads versus percutaneous leads.
- Being tested
- Spinal Cord Stimulation
- Keywords
- differential target multiplexed spinal cord stimulation
- 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
differential target multiplexed stimulation
| Study group | Role | What they receive |
|---|---|---|
| Spinal cord stimulation | Patients will receive differential target multiplexed 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.
Overall pain intensity with Visual Analogue Scale (VAS)
Overall pain, defined as a combination of back and leg pain, but not pain from other body parts, measured with the VAS (100mm)
Measured: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Secondary outcomes (20)
Back pain intensity with Visual Analogue Scale (VAS)
Measured: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Leg pain intensity with Visual Analogue Scale (VAS)
Measured: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Pain medication use
Open question regarding the dosage, frequency and type of pain medication
Measured: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Functional disability
The functional disabilities will be assessed with the Oswestry Disability Index (ODI)
Measured: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Health related quality of life
Health related quality of life, evaluated with the EuroQol with five dimensions and 5 levels
Measured: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Patient global impression of change
Patients will be asked to quantify the impression of change after treatment using the Patient Global Impression of Change scale (PGIC).
Measured: Evaluated at 1 month, 6 months and 12 months of DTM SCS.
Clinical holistic responder status
Measured: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Patients' individual competencies for self-management
Patient activation measure-13 (PAM) is a 13-item instrument which assesses self-reported behaviour, knowledge, and confidence for self-management of one's health.
Measured: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Work status
Work status is evaluated with a self-designed questionnaire
Measured: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Pain catastrophizing
The Pain Catastrophizing Scale (PCS) will be used to measure the level of pain catastrophizing
Measured: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Symptoms of central sensitisation.
The Central Sensitization Inventory is used to measure symptoms of central sensitisation
Measured: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Anxiety and Depression.
The hospital Anxiety and Depression Scale (HADS) will measure symptoms of anxiety and depression
Measured: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Healthcare utilisation.
Postoperative healthcare expenditure will be investigated by self-reporting methods.
Measured: The change between implantation and evaluation at 1 month, 6 months and 12 months of DTM SCS
Time spent in body postures
Based on the AdaptiveStim technology, the time spent in body postures can be recorded.
Measured: The data will be extracted from SCS implantation up to 1 month of SCS, from 1 month of SCS up to 6 months and from 6 months up to 12 months
(Serious) adverse events
Systematically recording all adverse events
Measured: Throughout study period
Proportion of successful DTM trials.
Measured: Evaluated after final SCS implantation
Battery consumption
Measured: Registration at 1 month, 6 months and 12 months of DTM SCS
Prevalence of technical issues with regard to DTM SCS programming
Measured: Throughout study period
DTM SCS stimulation parameters
Measured: Registration at 1 month, 6 months and 12 months of DTM SCS
Patient expectations concerning SCS
Self-constructed open question to evaluate patient expectations about SCS
Measured: Evaluated at baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start6 Oct 2021
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Moens Maarten
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Moens Maarten, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068011
- Sponsor's protocol ID
- DETECT
- Acronym
- DETECT
- Status last verified
- Aug 2024
- First submitted
- 9 Sep 2021
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Goudman L, De Smedt A, Eldabe S, Rigoard P, Billot M, Roulaud M; DETECT consortium; Moens M. Differential target multiplexed spinal cord stimulation in patients with Persistent Spinal Pain Syndrome Type II: a study protocol for a 12-month multicentre cohort study (DETECT). BMJ Open. 2024 Nov 9;14(11):e083610. doi: 10.1136/bmjopen-2023-083610.
PubMed 39521475
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differential Target Multiplexed Spinal Cord Stimulation: a Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT05068011
- Acronym / sponsor ID
- DETECT / DETECT
- Keywords
- differential target multiplexed spinal cord stimulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Moens MaartenUniversity, hospital or other
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 5 Oct 2021 (actual)
- 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.
Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of chronic back and leg pain. Additionally, a subgroup analysis will be performed to evaluate potential differences between paddle/surgical leads versus percutaneous leads.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal cord stimulation | – | Device: Spinal Cord StimulationPatients will receive differential target multiplexed spinal cord stimulation |
Who may qualify
- Ages
- 18 years and older
- 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 (FBSS)/Persistent Spinal Pain Syndrome type 2 (PSPS-T2), who will receive treatment with differential target multiplexed (DTM) SCS.
Key inclusion criteria (4 listed)
- Patients with severe chronic pain (> 5 on numeric rating scale, NRS) for at least 6 months due to FBSS (PSPS T2) and suitable for treatment with DTM SCS according to the treating physician
- Age > 18 years
- 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 the patient to receive or properly operate the spinal cord stimulation system
- History of coagulation disorder, lupus erythematosus, diabetic neuropathy, rheumatoid arthritis, or morbus Bechterew
- Active malignancy
- Addiction to drugs, alcohol (>5 units per day) and/or medication
- Evidence of an active disruptive psychiatric disorder or other known condition that may impact perception of pain, compliance to the 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 Stimulationdifferential target multiplexed stimulation | Device | Spinal cord stimulation |
Primary outcome
Overall pain intensity with Visual Analogue Scale (VAS)
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Overall pain, defined as a combination of back and leg pain, but not pain from other body parts, measured with the VAS (100mm)
20 secondary outcomes
Back pain intensity with Visual Analogue Scale (VAS)
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Leg pain intensity with Visual Analogue Scale (VAS)
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Pain medication use
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Functional disability
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Health related quality of life
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Patient global impression of change
Time frame: Evaluated at 1 month, 6 months and 12 months of DTM SCS.
Clinical holistic responder status
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Patients' individual competencies for self-management
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Work status
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Pain catastrophizing
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Symptoms of central sensitisation.
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Anxiety and Depression.
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Healthcare utilisation.
Time frame: The change between implantation and evaluation at 1 month, 6 months and 12 months of DTM SCS
Time spent in body postures
Time frame: The data will be extracted from SCS implantation up to 1 month of SCS, from 1 month of SCS up to 6 months and from 6 months up to 12 months
(Serious) adverse events
Time frame: Throughout study period
Proportion of successful DTM trials.
Time frame: Evaluated after final SCS implantation
Battery consumption
Time frame: Registration at 1 month, 6 months and 12 months of DTM SCS
Prevalence of technical issues with regard to DTM SCS programming
Time frame: Throughout study period
DTM SCS stimulation parameters
Time frame: Registration at 1 month, 6 months and 12 months of DTM SCS
Patient expectations concerning SCS
Time frame: Evaluated at baseline visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Derived from this study: PubMed 39521475Goudman L, De Smedt A, Eldabe S, Rigoard P, Billot M, Roulaud M; DETECT consortium; Moens M. Differential target multiplexed spinal cord stimulation in patients with Persistent Spinal Pain Syndrome Type II: a study protocol for a 12-month multicentre cohort study (DETECT). BMJ Open. 2024 Nov 9;14(11):e083610. doi: 10.1136/bmjopen-2023-083610.
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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.
14 sites 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 and Persistent Spinal Pain Syndrome Type 2, run by Moens Maarten at 14 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 4 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: status not confirmed, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maarten Moens, prof.dr. (+3224775514, maarten.moens@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall pain intensity with Visual Analogue Scale (VAS) (time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months). 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 NCT05068011, which also lists 1 linked publication.
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 16 Aug 2024.