NCT05068011RecruitingNot Applicable
Differential Target Multiplexed Spinal Cord Stimulation: a Multicenter Cohort Study
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Moens Maarten
- Enrollment
- 250
- Locations
- 14
- Primary Endpoint
- Overall pain intensity with Visual Analogue Scale (VAS)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
- Clinical holistic responder status(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- Pain catastrophizing(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- Symptoms of central sensitisation.(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- (Serious) adverse events(Throughout study period)
- Proportion of successful DTM trials.(Evaluated after final SCS implantation)
- Patient expectations concerning SCS(Evaluated at baseline visit)
- Pain medication use(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- Patient global impression of change(Evaluated at 1 month, 6 months and 12 months of DTM SCS.)
- Back pain intensity with Visual Analogue Scale (VAS)(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- Health related quality of life(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(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- DTM SCS stimulation parameters(Registration at 1 month, 6 months and 12 months of DTM SCS)
- Leg pain intensity with Visual Analogue Scale (VAS)(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- Functional disability(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- Work status(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- Anxiety and Depression.(The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months)
- Time spent in body postures(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)
- Battery consumption(Registration at 1 month, 6 months and 12 months of DTM SCS)
- Healthcare utilisation.(The change between implantation and evaluation at 1 month, 6 months and 12 months of DTM SCS)
- Prevalence of technical issues with regard to DTM SCS programming(Throughout study period)
Investigators
Moens Maarten
principal investigator
Universitair Ziekenhuis Brussel
Study Sites (14)
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