Failed Back Surgery Syndrome, Persistent Spinal Pain Syndrome Type 2
Conditions
Keywords
differential target multiplexed spinal cord stimulation
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.
Interventions
DEVICESpinal Cord Stimulation
differential target multiplexed stimulation
Sponsors
Moens Maarten
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| 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) |
| 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 |
| 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). |
| 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 | 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. |
| 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 |
| DTM SCS stimulation parameters | Registration at 1 month, 6 months and 12 months of DTM SCS | — |
| 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 |
| 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 |
| 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. |
| 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. |
| (Serious) adverse events | Throughout study period | Systematically recording all adverse events |
| 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 | — |
| Patient expectations concerning SCS | Evaluated at baseline visit | Self-constructed open question to evaluate patient expectations about SCS |
| 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 |
Countries
Belgium
Contacts
Primary ContactMaarten Moens, prof.dr.
Backup ContactLisa Goudman, PhD
Outcome results
None listed