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Evaluation of the effectiveness of differential target multiplexed spinal cord stimulation for treatment of Persistent Spinal Pain Syndrome Type II (PSPS-T2). Identification of clinical effective parameters concerning frequency, pulse duration, amplitude and battery consumption/recharge frequency and safety evaluation.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulation | Device | Differential target multiplexed stimulation |
| Measure | Description | Time Frame |
|---|---|---|
| Overall pain intensity | The primary effectiveness outcome measure is pain intensity measured with the Visual Analogue Scale (VAS), ranging from 0 (no pain) to 100 (maximal pain) in electronic format. Two scales will be presented for low back/neck pain and for leg/arm pain. Ecological momentary Assessment (EMA) will be used to collect pain intensity scores for VAS, whereby pain intensity is measured for multiple times per day for 1 week to reveal patterns of transient or fluctuating symptoms in the environment and context of the patients' lives, without a recall bias. | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity for the lower back and leg pain or neck and arm pain component | Pain intensity for the lower back and leg pain or neck and arm pain component will be assessed separately with the Numeric Rating Scale (0 to 10). Pain intensity for the last 7 days will be assessed in electronic format, with and without medication use. | 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 Persistent Spinal Pain Syndrome type 2 (PSPS-T2), who will receive treatment with differential target multiplexed (DTM) SCS.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Maarten TA Moens, MD, PhD | Contact | 003224775514 | maarten.moens@uzbrussel.be | |
| Lisa Goudman, PT, MSc, PhD | Contact | 003224775514 | lisa.goudman@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Brussels | Belgium |
|
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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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| Medication use | Open question regarding the use of medication (collected through ecological momentary assessment for 1 week). | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months |
| Negative affect | Questions on a 9-point scale for negative affects, evaluated through ecological momentary assessment for 7 days. | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months |
| Functional disability | The Oswestry disability index (ODI; 0 to 100) or Neck disability index (NDI; 0 to 100) is used to measure functional disability due to abnormalities of the spine | 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 | This is a composite measure for success, relying on the combination of the above questionnaires. | 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 |
| 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 |
| Patient expectations concerning SCS | Self-constructed open question to evaluate patient expectations about SCS | Evaluated at baseline visit |
| Patient unwanted stimulation awareness and satisfaction about the therapy | investigated by self-reporting methods with 12 questions | Evaluated 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, an average of 1 year |
| Proportion of successful DTM trials | Evaluated after final SCS implantation |
| Technical IPG details (ECAPs etc.) | Information from implantable pulse generators will be extracted. | Registration at 1 month, 6 months and 12 months of DTM SCS |
| DTM SCS stimulation parameters | Information from implantable pulse generators will be extracted. | Time Frame: Registration at 1 month, 6 months and 12 months of DTM SCS |
| Battery consumption | Information from implantable pulse generators will be extracted. | 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, an average of 1 year |
| Actigraphy data | A Garmin Venue series watch will be used to collect actigraphy data. Devices are worn for 7 consecutive days. This data will only be collected at Belgian sites. | The change between the baseline screening and the evaluation 1 month after DTM stimulation, 6 months and 12 months |
| Vitaz | Sint-Niklaas | Belgium |
|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |