An observational study in Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome and Failed Neck Surgery Syndrome, sponsored by Universitair Ziekenhuis Brussel. Recruiting at 5 sites in 2 countries. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Universitair Ziekenhuis Brussel · Observational
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.
104 studies on the registry are indexed under Failed Back Surgery Syndrome; 17 are open to participants now.
This study's planned enrollment of 200 is above the median of 86 across 26 observational studies indexed under Failed Back Surgery Syndrome.
Browse Failed Back Surgery Syndrome studies →Universitair Ziekenhuis Brussel is the lead sponsor of 375 studies on the registry; 107 are open to participants now.
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Patients with Persistent Spinal Pain Syndrome type 2 (PSPS-T2), who will receive treatment with differential target multiplexed (DTM) SCS.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Differential target multiplexed stimulation
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.
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
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.
Time frame: 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).
Time frame: 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.
Time frame: 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
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
Health related quality of life, evaluated with the EuroQol with five dimensions and 5 levels
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
Patients will be asked to quantify the impression of change after treatment using the Patient Global Impression of Change scale (PGIC)
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
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
Self-constructed open question to evaluate patient expectations about SCS
Time frame: Evaluated at baseline visit
Patient unwanted stimulation awareness and satisfaction about the therapy
investigated by self-reporting methods with 12 questions
Time frame: 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
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
Systematically recording all 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.)
Information from implantable pulse generators will be extracted.
Time frame: Registration at 1 month, 6 months and 12 months of DTM SCS
DTM SCS stimulation parameters
Information from implantable pulse generators will be extracted.
Time frame: Time Frame: Registration at 1 month, 6 months and 12 months of DTM SCS
Battery consumption
Information from implantable pulse generators will be extracted.
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
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.
Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Dec 2025 (actual). Primary completion is estimated for Jan 2028, 24 months after the start.
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