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Not yet recruiting NCT07211308

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

— Observational Persistent Spinal Pain Syndrome Type 2 Failed Back Surgery Syndrome Failed Neck Surgery Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Spinal Cord Stimulation.
Who it may be relevant to
Registry conditions: Persistent Spinal Pain Syndrome Type 2, Failed Back Surgery Syndrome, Failed Neck Surgery Syndrome. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Interventions

  • Device Spinal Cord Stimulation
    Differential target multiplexed stimulation

Primary outcome measures

  • Overall pain intensity [Time frame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Belgium · 2 centers
  • UZ Brussel — Brussels
  • Vitaz — Sint-Niklaas

Identifiers

NCT: NCT07211308 · ENDLESS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗