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Recruiting NCT05068011

Differential Target Multiplexed Spinal Cord Stimulation

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

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: Failed Back Surgery Syndrome, Persistent Spinal Pain Syndrome Type 2. Basic parameters: from 18 years · 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

Differential Target Multiplexed Spinal Cord Stimulation: a Multicenter Cohort Study

Overview

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.

Interventions

  • Device Spinal Cord Stimulation
    differential target multiplexed stimulation

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
  • Life expectancy < 1 year
  • Local infection or any 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 · 14 centers
  • Universitair Ziekenhuis Brussel — Jette
  • ZNA — Antwerp
  • AZ Sint-Jan Brugge-Oostende — Bruges
  • AZ Sint-Lucas Brugge — Bruges
  • Jessa Ziekenhuis — Hasselt
  • AZ Groeninge — Kortrijk
  • UZ Leuven — Leuven
  • Heilig Hart Ziekenhuis Lier — Lier
  • … and 6 more centers

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. PMID 39521475

Identifiers

NCT: NCT05068011 · DETECT

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗