Clinical trial NCT05068011: Differential Target Multiplexed Spinal Cord Stimulation
Official title: Differential Target Multiplexed Spinal Cord Stimulation: a Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Failed Back Surgery Syndrome
Persistent Spinal Pain Syndrome Type 2
Keywords: differential target multiplexed spinal cord stimulation
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic back and leg pain due to Failed Back Surgery Syndrome (FBSS)/Persistent Spinal Pain Syndrome type 2 (PSPS-T2), who will receive treatment with differential target multiplexed (DTM) SCS.

Brief summary: 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.


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

Primary outcomes:
measure: Overall pain intensity with Visual Analogue Scale (VAS)
timeFrame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
Secondary outcomes:
measure: Back pain intensity with Visual Analogue Scale (VAS)
timeFrame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
measure: Leg pain intensity with Visual Analogue Scale (VAS)
timeFrame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
measure: Pain medication use
timeFrame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
measure: Functional disability
timeFrame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
measure: Health related quality of life
timeFrame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
measure: Patient global impression of change
timeFrame: Evaluated at 1 month, 6 months and 12 months of DTM SCS.
measure: Clinical holistic responder status
timeFrame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
measure: Patients' individual competencies for self-management
timeFrame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
measure: Work status
timeFrame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
measure: Pain catastrophizing
timeFrame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
measure: Symptoms of central sensitisation.
timeFrame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
measure: Anxiety and Depression.
timeFrame: The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months
measure: Healthcare utilisation.
timeFrame: The change between implantation and evaluation at 1 month, 6 months and 12 months of DTM SCS
measure: Time spent in body postures
timeFrame: 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
measure: (Serious) adverse events
timeFrame: Throughout study period
measure: Proportion of successful DTM trials.
timeFrame: Evaluated after final SCS implantation
measure: Battery consumption
timeFrame: Registration at 1 month, 6 months and 12 months of DTM SCS
measure: Prevalence of technical issues with regard to DTM SCS programming
timeFrame: Throughout study period
measure: DTM SCS stimulation parameters
timeFrame: Registration at 1 month, 6 months and 12 months of DTM SCS
measure: Patient expectations concerning SCS
timeFrame: Evaluated at baseline visit
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Universitair Ziekenhuis Brussel
state: Brussel
city: Antwerpen
country: Belgium
facility: ZNA
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende
city: Brugge
country: Belgium
facility: AZ Sint-Lucas Brugge
city: Hasselt
country: Belgium
facility: Jessa Ziekenhuis
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: Leuven
country: Belgium
facility: UZ Leuven
city: Lier
country: Belgium
facility: Heilig Hart Ziekenhuis Lier
city: Liège
country: Belgium
facility: Centre Hospitalier Régional (CHR) de la Citadelle
city: Mechelen
country: Belgium
facility: AZ Sint-Maarten
city: Roeselare
country: Belgium
facility: AZ Delta
city: Sint-Niklaas
country: Belgium
facility: Vitaz
city: Turnhout
country: Belgium
facility: AZ Turnhout
city: Wilrijk
country: Belgium
facility: GZA
Study officials:
References: