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Sponsor withdrawn due to low inclusion rate
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24-SMI-2014 is a Randomised Controlled Trial with an optional one way cross-over comparing Conservative Medical Management (CMM) to treatment with the Axium neurostimulator + CMM. Subject population is chronic inguinal pain refractory to previous surgical intervention (neurectomy).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conservative Medical Management | No Intervention | Continued medical management restricted to exclude interventional pain treatments | |
| Axium Group | Active Comparator | As the CMM group but also treated with Dorsal Root Ganglion stimulation using the Axium neurostimulator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Implantation with the commercially available Axium neurostimulator | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects experiencing ≥50% reduction in average daily pain intensity in the Axium Group as compared to the CMM only group using an eleven point (0-10) numerical pain rating scale (NPRS) | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Máxima Medisch Centrum | Eindhoven | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36456417 | Derived | Mol F, Scheltinga M, Roumen R, Wille F, Gultuna I, Kallewaard JW, Elzinga L, van de Minkelis J, Nijhuis H, Stronks DL, Huygen FJPM. Comparing the Efficacy of Dorsal Root Ganglion Stimulation With Conventional Medical Management in Patients With Chronic Postsurgical Inguinal Pain: Post Hoc Analyzed Results of the SMASHING Study. Neuromodulation. 2023 Dec;26(8):1788-1794. doi: 10.1016/j.neurom.2022.09.014. Epub 2022 Nov 29. | |
| 29587729 |
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| Derived |
| Mol FMU, Roumen RM, Scheltinga MR. Comparing the efficacy of targeted spinal cord stimulation (SCS) of the dorsal root ganglion with conventional medical management (CMM) in patients with chronic post-surgical inguinal pain: the SMASHING trial. BMC Surg. 2018 Mar 27;18(1):18. doi: 10.1186/s12893-018-0349-8. |