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NCT Number: NCT07211308

Open and Closed Loop DTM SCS in Patients With PSPS Type 2: ENDLESS Study

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.

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Key information

Conditions

Persistent Spinal Pain Syndrome Type 2 Back Pain Failed Back Surgery Syndrome Failed Neck Surgery Syndrome Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Brussel, Brussels, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • Life expectancy < 1 year
  • Local infection or other skin disorder at site of incision
  • Pregnancy
  • Other implanted active medical device

Treatment and study plan

Spinal Cord Stimulation

Device

Differential target multiplexed stimulation

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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.

  2. Medication use

    Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months

    Open question regarding the use of medication (collected through ecological momentary assessment for 1 week).

  3. Negative affect

    Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months

    Questions on a 9-point scale for negative affects, evaluated through ecological momentary assessment for 7 days.

  4. Functional disability

    Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months

    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

  5. 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

    Health related quality of life, evaluated with the EuroQol with five dimensions and 5 levels

  6. Patient global impression of change

    Time frame: Evaluated at 1 month, 6 months and 12 months of DTM SCS

    Patients will be asked to quantify the impression of change after treatment using the Patient Global Impression of Change scale (PGIC)

  7. 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

    This is a composite measure for success, relying on the combination of the above questionnaires.

  8. Work status

    Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months

    Work status is evaluated with a self-designed questionnaire

  9. Pain catastrophizing

    Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months

    The Pain Catastrophizing Scale (PCS) will be used to measure the level of pain catastrophizing

  10. Anxiety and Depression

    Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months

    The hospital Anxiety and Depression Scale (HADS) will measure symptoms of anxiety and depression

  11. Patient expectations concerning SCS

    Time frame: Evaluated at baseline visit

    Self-constructed open question to evaluate patient expectations about SCS

  12. Patient unwanted stimulation awareness and satisfaction about the therapy

    Time frame: Evaluated at 1 month, 6 months and 12 months of DTM SCS

    investigated by self-reporting methods with 12 questions

  13. 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

    Based on the AdaptiveStim technology, the time spent in body postures can be recorded

  14. (Serious) adverse events

    Time frame: Throughout study period, an average of 1 year

    Systematically recording all adverse events

  15. Proportion of successful DTM trials

    Time frame: Evaluated after final SCS implantation

  16. Technical IPG details (ECAPs etc.)

    Time frame: Registration at 1 month, 6 months and 12 months of DTM SCS

    Information from implantable pulse generators will be extracted.

  17. DTM SCS stimulation parameters

    Time frame: Time Frame: Registration at 1 month, 6 months and 12 months of DTM SCS

    Information from implantable pulse generators will be extracted.

  18. Battery consumption

    Time frame: Registration at 1 month, 6 months and 12 months of DTM SCS

    Information from implantable pulse generators will be extracted.

  19. Prevalence of technical issues with regard to DTM SCS programming

    Time frame: Throughout study period, an average of 1 year

  20. Actigraphy data

    Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lisa Goudman, PT, MSc, PhD

CONTACT

[email protected]

003224775514

Maarten TA Moens, MD, PhD

CONTACT

[email protected]

003224775514

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study 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)

Acronym: ENDLESS

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Oct 7, 2025
Registry last updated
Oct 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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