Differential Target Multiplexed Spinal Cord Stimulation

Study Overview
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Brief Summary
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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.

Official Title
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Differential Target Multiplexed Spinal Cord Stimulation: a Multicenter Cohort Study

Conditions
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Failed Back Surgery Syndrome, Persistent Spinal Pain Syndrome Type 2

Intervention / Treatment
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* Device: Spinal Cord Stimulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Spinal cord stimulation<br>Patients will receive differential target multiplexed spinal cord stimulation | Device: Spinal Cord Stimulation<br>* differential target multiplexed stimulation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall pain intensity with Visual Analogue Scale (VAS) | Overall pain, defined as a combination of back and leg pain, but not pain from other body parts, measured with the VAS (100mm) | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| Pain medication use | Open question regarding the dosage, frequency and type of pain medication | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months | 
| Functional disability | The functional disabilities will be assessed with the Oswestry Disability Index (ODI) | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months | 
| Health related quality of life | Health related quality of life, evaluated with the EuroQol with five dimensions and 5 levels | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months | 
| Patient global impression of change | Patients will be asked to quantify the impression of change after treatment using the Patient Global Impression of Change scale (PGIC). | Evaluated at 1 month, 6 months and 12 months of DTM SCS. | 
| Clinical holistic responder status |  | 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 | 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. | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months | 
| Work status | Work status is evaluated with a self-designed questionnaire | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months | 
| Pain catastrophizing | The Pain Catastrophizing Scale (PCS) will be used to measure the level of 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 Central Sensitization Inventory is used to measure symptoms of central sensitisation | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months | 
| Anxiety and Depression. | The hospital Anxiety and Depression Scale (HADS) will measure symptoms of anxiety and depression | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months | 
| Healthcare utilisation. | Postoperative healthcare expenditure will be investigated by self-reporting methods. | The change between implantation and evaluation at 1 month, 6 months and 12 months of DTM SCS | 
| Time spent in body postures | Based on the AdaptiveStim technology, the time spent in body postures can be recorded. | 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 | 
| (Serious) adverse events | Systematically recording all adverse events | Throughout study period | 
| Proportion of successful DTM trials. |  | Evaluated after final SCS implantation | 
| Battery consumption |  | Registration at 1 month, 6 months and 12 months of DTM SCS | 
| Prevalence of technical issues with regard to DTM SCS programming |  | Throughout study period | 
| DTM SCS stimulation parameters |  | Registration at 1 month, 6 months and 12 months of DTM SCS | 
| Patient expectations concerning SCS | Self-constructed open question to evaluate patient expectations about SCS | Evaluated at baseline visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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differential target multiplexed spinal cord stimulation