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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal cord stimulation | Patients will receive differential target multiplexed spinal cord stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulation | Device | differential target multiplexed stimulation |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maarten Moens, prof.dr. | Contact | +3224775514 | maarten.moens@uzbrussel.be | |
| Lisa Goudman, PhD | Contact | +3224775514 | lisa.goudman@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitair Ziekenhuis Brussel | Recruiting | Jette | Brussels Capital | 1090 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39521475 | Derived | Goudman L, De Smedt A, Eldabe S, Rigoard P, Billot M, Roulaud M; DETECT consortium; Moens M. Differential target multiplexed spinal cord stimulation in patients with Persistent Spinal Pain Syndrome Type II: a study protocol for a 12-month multicentre cohort study (DETECT). BMJ Open. 2024 Nov 9;14(11):e083610. doi: 10.1136/bmjopen-2023-083610. |
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| ID | Term |
|---|---|
| D055111 | Failed Back Surgery Syndrome |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001416 | Back Pain |
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| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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| 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 |
| ZNA | Recruiting | Antwerp | Belgium |
|
| AZ Sint-Jan Brugge-Oostende | Recruiting | Bruges | Belgium |
|
| AZ Sint-Lucas Brugge | Recruiting | Bruges | Belgium |
|
| Jessa Ziekenhuis | Recruiting | Hasselt | Belgium |
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| AZ Groeninge | Recruiting | Kortrijk | Belgium |
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| UZ Leuven | Recruiting | Leuven | Belgium |
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| Heilig Hart Ziekenhuis Lier | Recruiting | Lier | Belgium |
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| Centre Hospitalier Régional (CHR) de la Citadelle | Recruiting | Liège | Belgium |
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| AZ Sint-Maarten | Recruiting | Mechelen | Belgium |
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| AZ Delta | Recruiting | Roeselare | Belgium |
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| Vitaz | Recruiting | Sint-Niklaas | Belgium |
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| AZ Turnhout | Recruiting | Turnhout | Belgium |
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| GZA | Recruiting | Wilrijk | Belgium |
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |