Persistent Spinal Pain Syndrome Type 2ENDLESSNCT07211308
Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study
An observational study of Persistent Spinal Pain Syndrome Type 2 and Failed Back Surgery Syndrome, run by Universitair Ziekenhuis Brussel at 5 sites in 2 countries.
Trial summary
Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of Persistent Spinal Pain Syndrome Type II (PSPS-T2). Identification of clinical effective parameters concerning frequency, pulse duration, amplitude and battery consumption/recharge frequency and safety evaluation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome, Failed Neck Surgery Syndrome
- What is being tested?
- Spinal Cord Stimulation
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 12 Dec 2025to 1 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with Persistent Spinal Pain Syndrome type 2 (PSPS-T2), who will receive treatment with differential target multiplexed (DTM) SCS.
Who may be able to join
- having chronic pain as a result of PSPS-T2 that exists for at least 6 months with at least moderate pain intensity (4 or higher measured on numeric rating scale (NRS) or 31mm or higher measured on visual analogue scale (VAS) for the dominant pain location.
- being offered treatment with DTM SCS
- being at least 18 years old
Who cannot join
- Expected inability of patients to properly operate the SCS system
- History of coagulation disorders, lupus erythematosus, diabetic neuropathy
- Active malignancy
- Addiction to drugs and/or alcohol (more than 5 units /day)
- 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 complete questionnaires, as determined by the investigator
- Immune deficiency (e.g. HIV positive, immunosuppressiva)
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
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
Belgium3 sites, 3 recruiting
- Not yet recruiting
UZ Brussel
Brussels
Maarten Moens, MD PhD
Lisa Goudman, PhD
- Recruiting
AZ Delta
Roeselare
Bart Billet, MD
- Recruiting
Vitaz
Sint-Niklaas
Iris Smet, MD
Netherlands2 sites, 2 recruiting
- Recruiting
Rijnstate ziekenhuis
Arnhem
Jan Willem Kallewaard, MD PhD
- Recruiting
Radboudumc
Nijmegen
Mark van Ooijen, MD
About this study
Official title: Open and Closed Loop Differential Target Multiplexed Spinal Cord Stimulation in Patients With Persistent Spinal Pain Syndrome Type II: a European Multicenter Cohort Study (ENDLESS)
Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of Persistent Spinal Pain Syndrome Type II (PSPS-T2). Identification of clinical effective parameters concerning frequency, pulse duration, amplitude and battery consumption/recharge frequency and safety evaluation.
- Conditions
- Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome, Failed Neck Surgery Syndrome
- Being tested
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall pain intensity
The primary effectiveness outcome measure is pain intensity measured with the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 100 (maximal pain) in electronic format. Two scales will be presented for low back/neck pain and for leg/arm pain. Ecological momentary Assessment (EMA) will be used to collect pain intensity scores for VAS, whereby pain intensity is measured for multiple times per day for 1 week to reveal patterns of transient or fluctuating symptoms in the environment and context of the patients' lives, without a recall bias.
Measured: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Secondary outcomes (20)
Pain intensity for the lower back and leg pain or neck and arm pain component
Pain intensity for the lower back and leg pain or neck and arm pain component will be assessed separately with the Numeric Rating Scale (0 to 10). Pain intensity for the last 7 days will be assessed in electronic format, with and without medication use.
Measured: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Medication use
Open question regarding the use of medication (collected through ecological momentary assessment for 1 week).
Measured: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Negative affect
Questions on a 9-point scale for negative affects, evaluated through ecological momentary assessment for 7 days.
Measured: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Functional disability
The Oswestry disability index (ODI; 0 to 100) or Neck disability index (NDI; 0 to 100) is used to measure functional disability due to abnormalities of the spine
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
This is a composite measure for success, relying on the combination of the above questionnaires.
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
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
Patient expectations concerning SCS
Self-constructed open question to evaluate patient expectations about SCS
Measured: Evaluated at baseline visit
Patient unwanted stimulation awareness and satisfaction about the therapy
investigated by self-reporting methods with 12 questions
Measured: Evaluated 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, an average of 1 year
Proportion of successful DTM trials
Measured: Evaluated after final SCS implantation
Technical IPG details (ECAPs etc.)
Information from implantable pulse generators will be extracted.
Measured: Registration at 1 month, 6 months and 12 months of DTM SCS
DTM SCS stimulation parameters
Information from implantable pulse generators will be extracted.
Measured: Time Frame: Registration at 1 month, 6 months and 12 months of DTM SCS
Battery consumption
Information from implantable pulse generators will be extracted.
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, an average of 1 year
Actigraphy data
A Garmin Venue series watch will be used to collect actigraphy data. Devices are worn for 7 consecutive days. This data will only be collected at Belgian sites.
Measured: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 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 posted7 Oct 2025
- Study start12 Dec 2025
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2029 (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 Persistent Spinal Pain Syndrome Type 2Studies 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211308
- Sponsor's protocol ID
- ENDLESS
- Acronym
- ENDLESS
- Status last verified
- Aug 2026
- First submitted
- 7 Nov 2024
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Goudman L, Gatzinsky K, Mehta V, Poply K, Gulve A, Smet I, Murphy P, Rasche D, Matis G, Kallewaard JW, Trinidad JM, De Negri P, Rigoard P; ENDLESS consortium; Moens M. Open and closed loop differential target multiplexed spinal cord stimulation in patients with persistent spinal pain syndrome type II: protocol for a one year European multicenter cohort study (ENDLESS). Front Pain Res (Lausanne). 2026 Aug 19;7:1922595. doi: 10.3389/fpain.2026.1922595. eCollection 2026.
PubMed 42688391
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open and Closed Loop Differential Target Multiplexed Spinal Cord Stimulation in Patients With Persistent Spinal Pain Syndrome Type II: a European Multicenter Cohort Study (ENDLESS)
- ClinicalTrials.gov ID
- NCT07211308
- Acronym / sponsor ID
- ENDLESS / ENDLESS
- Conditions
- Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome, Failed Neck Surgery Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 7 Oct 2025 (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 Persistent Spinal Pain Syndrome Type II (PSPS-T2). Identification of clinical effective parameters concerning frequency, pulse duration, amplitude and battery consumption/recharge frequency and safety evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with Persistent Spinal Pain Syndrome type 2 (PSPS-T2), who will receive treatment with differential target multiplexed (DTM) SCS.
Key inclusion criteria (3 listed)
- having chronic pain as a result of PSPS-T2 that exists for at least 6 months with at least moderate pain intensity (4 or higher measured on numeric rating scale (NRS) or 31mm or higher measured on visual analogue scale (VAS) for the dominant pain location.
- being offered treatment with DTM SCS
- being at least 18 years old
Key exclusion criteria (10 listed)
- Expected inability of patients to properly operate the SCS system
- History of coagulation disorders, lupus erythematosus, diabetic neuropathy
- Active malignancy
- Addiction to drugs and/or alcohol (more than 5 units /day)
- 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 complete questionnaires, as determined by the 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 | – |
Primary outcome
Overall pain intensity
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
The primary effectiveness outcome measure is pain intensity measured with the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 100 (maximal pain) in electronic format. Two scales will be presented for low back/neck pain and for leg/arm pain. Ecological momentary Assessment (EMA) will be used to collect pain intensity scores for VAS, whereby pain intensity is measured for multiple times per day for 1 week to reveal patterns of transient or fluctuating symptoms in the environment and context of the patients' lives, without a recall bias.
20 secondary outcomes
Pain intensity for the lower back and leg pain or neck and arm pain component
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Medication use
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Negative affect
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
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
Anxiety and Depression
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Patient expectations concerning SCS
Time frame: Evaluated at baseline visit
Patient unwanted stimulation awareness and satisfaction about the therapy
Time frame: Evaluated 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, an average of 1 year
Proportion of successful DTM trials
Time frame: Evaluated after final SCS implantation
Technical IPG details (ECAPs etc.)
Time frame: Registration at 1 month, 6 months and 12 months of DTM SCS
DTM SCS stimulation parameters
Time frame: Time Frame: Registration at 1 month, 6 months and 12 months of DTM SCS
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, an average of 1 year
Actigraphy data
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Derived from this study: PubMed 42688391Goudman L, Gatzinsky K, Mehta V, Poply K, Gulve A, Smet I, Murphy P, Rasche D, Matis G, Kallewaard JW, Trinidad JM, De Negri P, Rigoard P; ENDLESS consortium; Moens M. Open and closed loop differential target multiplexed spinal cord stimulation in patients with persistent spinal pain syndrome type II: protocol for a one year European multicenter cohort study (ENDLESS). Front Pain Res (Lausanne). 2026 Aug 19;7:1922595. doi: 10.3389/fpain.2026.1922595. eCollection 2026.
- Individual participant dataSharing planned: Undecided
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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.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Persistent Spinal Pain Syndrome Type 2 and Failed Back Surgery Syndrome, run by Universitair Ziekenhuis Brussel at 5 sites in 2 countries.
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 3 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maarten TA Moens, MD, PhD (003224775514, 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 (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 NCT07211308, 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 17 Aug 2026.