Differential Target Multiplexed Spinal Cord Stimulation
- Conditions
- Persistent Spinal Pain Syndrome Type 2Failed Back Surgery Syndrome
- Interventions
- Device: Spinal Cord Stimulation
- Registration Number
- NCT05068011
- Lead Sponsor
- Moens Maarten
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Spinal cord stimulation Spinal Cord Stimulation Patients will receive differential target multiplexed spinal cord stimulation
- Primary Outcome Measures
Name Time Method Overall 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 Overall pain, defined as a combination of back and leg pain, but not pain from other body parts, measured with the VAS (100mm)
- Secondary Outcome Measures
Name Time Method 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 The Pain Catastrophizing Scale (PCS) will be used to measure the level of pain catastrophizing
Symptoms of central sensitisation. 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
(Serious) adverse events Throughout study period Systematically recording all adverse events
Proportion of successful DTM trials. Evaluated after final SCS implantation Patient expectations concerning SCS Evaluated at baseline visit Self-constructed open question to evaluate patient expectations about SCS
Pain medication use 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
Patient global impression of change 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).
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 Health related quality of life, evaluated with the EuroQol with five dimensions and 5 levels
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 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.
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 The functional disabilities will be assessed with the Oswestry Disability Index (ODI)
Work status 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
Anxiety and Depression. 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
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 Based on the AdaptiveStim technology, the time spent in body postures can be recorded.
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 Postoperative healthcare expenditure will be investigated by self-reporting methods.
Prevalence of technical issues with regard to DTM SCS programming Throughout study period
Trial Locations
- Locations (14)
AZ Sint-Jan Brugge-Oostende
🇧🇪Brugge, Belgium
ZNA
🇧🇪Antwerpen, Belgium
Universitair Ziekenhuis Brussel
🇧🇪Jette, Brussel, Belgium
AZ Sint-Lucas Brugge
🇧🇪Brugge, Belgium
Jessa Ziekenhuis
🇧🇪Hasselt, Belgium
AZ Groeninge
🇧🇪Kortrijk, Belgium
UZ Leuven
🇧🇪Leuven, Belgium
Heilig Hart Ziekenhuis Lier
🇧🇪Lier, Belgium
AZ Sint-Maarten
🇧🇪Mechelen, Belgium
Vitaz
🇧🇪Sint-Niklaas, Belgium
AZ Delta
🇧🇪Roeselare, Belgium
AZ Turnhout
🇧🇪Turnhout, Belgium
GZA
🇧🇪Wilrijk, Belgium
Centre Hospitalier Régional (CHR) de la Citadelle
🇧🇪Liège, Belgium