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NCT Number: NCT05068011

Differential Target Multiplexed Spinal Cord Stimulation

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitair Ziekenhuis Brussel, Jette, Brussels Capital, Belgium

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Spinal Cord Stimulation

Device

differential target multiplexed stimulation

Primary outcomes

  1. 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

    Overall pain, defined as a combination of back and leg pain, but not pain from other body parts, measured with the VAS (100mm)

Secondary outcomes

  1. 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

  2. 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

  3. Pain 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 dosage, frequency and type of pain medication

  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 functional disabilities will be assessed with the Oswestry Disability Index (ODI)

  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

  8. 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

    Patient activation measure-13 (PAM) is a 13-item instrument which assesses self-reported behaviour, knowledge, and confidence for self-management of one's health.

  9. 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

  10. 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

  11. 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

    The Central Sensitization Inventory is used to measure symptoms of central sensitisation

  12. 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

  13. Healthcare utilisation.

    Time frame: The change between implantation and evaluation at 1 month, 6 months and 12 months of DTM SCS

    Postoperative healthcare expenditure will be investigated by self-reporting methods.

  14. 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.

  15. (Serious) adverse events

    Time frame: Throughout study period

    Systematically recording all adverse events

  16. Proportion of successful DTM trials.

    Time frame: Evaluated after final SCS implantation

  17. Battery consumption

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

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

    Time frame: Throughout study period

  19. DTM SCS stimulation parameters

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

  20. Patient expectations concerning SCS

    Time frame: Evaluated at baseline visit

    Self-constructed open question to evaluate patient expectations about SCS

Study contacts

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

Lisa Goudman, PhD

CONTACT

[email protected]

+3224775514

Maarten Moens, prof.dr.

CONTACT

[email protected]

+3224775514

Sponsors and collaborators

Lead sponsor

Moens Maarten

Other

Registry information

Official study title

Differential Target Multiplexed Spinal Cord Stimulation: a Multicenter Cohort Study

Acronym: DETECT

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Oct 5, 2021
Registry last updated
Aug 16, 2024

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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