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| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
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Rationale: For patients with mononeuropathy, literature has shown that spinal cord stimulation (SCS) is an effective therapy for patients who are therapy-resistant to more conventional treatments. However, there is a strong need for higher quality evidence to determine the place of this therapy in this target group. Before conducting a large randomized controlled trial (RCT) we propose to conduct an explorative pilot study based on which an effect size estimation and power calculation for a larger study can be done. We will assess the effects of SCS in patients with mononeuropathy measured according to the "Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials" (IMMPACT) guidelines, and assess the stimulation paradigm preferences in these patients.
Objective: To perform an explorative pilot study based on which an effect size estimation and power calculation for an efficacy trial can be done.
Study design: Mono-center explorative pilot study in 12 patients with intractable peripheral mononeuropathic pain who receive a spinal cord stimulator at the Erasmus Medical Centre.
Study population: 12 patients suffering from intractable peripheral mononeuropathic pain.
Intervention: Participants who receive a spinal cord stimulator must fill in IMMPACT guideline questionnaires and undergo several measurement procedures after receiving SCS implantation. The effect of various SCS paradigms on the chronic mononeuropathic pain is assessed at 3 and 6 months.
Main study parameters/endpoints: Effect of 6 months of individually optimized SCS in patients with mononeuropathy according to the IMMPACT guidelines.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal cord stimulation | Experimental | Patients are all included in this experimental arm, where they receive all four stimulation options consecutively, but in different orders. After receiving all four stimulation options, the patients are allowed to choose which stimulation option of the four they want to have for the following period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal cord stimulator | Device | Electrical stimulation of the dorsal horn to reduce chronic pain. |
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| Measure | Description | Time Frame |
|---|---|---|
| Effect of spinal cord stimulation (SCS) in patients with mononeuropathy as assessed by the perceived pain intensity. | Perceived pain intensity as assessed by the brief pain inventory (BPI), with pain scores where 0 is no pain and 10 is worst pain imaginable. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of SCS in patients with mononeuropathy as assessed by quantitative sensory testing (QST). | Quantitative sensory testing (QST) measures sensory thresholds for pain, touch, vibration, and temperature sensations, with the main goal to assess sensory functioning. | 6 months |
| Effect of SCS in patients with mononeuropathy on quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mathilde Scholtes, MSc | Contact | +31650032165 | m.m.a.scholtes@erasmusmc.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus Medical Centre | Recruiting | Rotterdam | South Holland | 3015GD | Netherlands |
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| ID | Term |
|---|---|
| D020422 | Mononeuropathies |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
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Mono-center explorative pilot study in 12 patients
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Quality of life as assessed by the EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) questionnaire. |
| 6 months |
| Patient preferences for SCS paradigms as assessed by the perceived pain intensity. | Perceived pain intensity as assessed by the brief pain inventory (BPI), with pain scores where 0 is no pain and 10 is worst pain imaginable. | 3 months |