A Multi-Centre RCT of the Axium® Neurostimulator for the Treatment of Chronic Inguinal Pain Following Surgery

Study Overview
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Brief Summary
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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).

Official Title
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A Randomised Controlled Trial to Evaluate the Efficacy of the Spinal Modulation Axium® NeuroStimulator THerapy as a Treatment for Persistent INGuinal Pain Following Surgical Intervention: SMASHING

Conditions
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Chronic Inguinal Pain Refractory to Previous Surgical Intervention (Neurectomy)

Intervention / Treatment
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* Device: Implantation with the commercially available Axium neurostimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is at least 18 years old Subject is able and willing to comply with the follow-up schedule and protocol Chronic inguinal pain following Pfannenstiel Incision or Open Inguinal Hernia Repair for at least 6 months Previously undergone neurectomy procedure as a treatment for chronic inguinal pain Minimum daily average baseline pain rating of 5 out of 10 in the inguinal area on an 11-point NPRS Subject is able to provide written informed consent Meets of the inclusion criteria for the implantation of a neurostimulation system as set out by the Dutch Neuromodulation Society Subject has been screened by a multi-disciplinary panel including the designated psychologist of the Máxima Medical Center and deemed suitable for implantation Exclusion Criteria: Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the Trial Escalating or changing pain condition within the past month as evidenced by investigator examination Subject has had injection therapy or radiofrequency treatment of a target neural structure within the past 3 months Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump Subject is unable to operate the device Subjects currently has an active infection Subject has participated in another clinical investigation within 30 days Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation Subject has a current or on going condition, which will probably require MRI investigation sometime in the following 2 years Subject has had a spinal surgical procedure at or between vertebral levels T10-L2 Subject has been diagnosed with cancer in the past 2 years, except for skin malignancies.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conservative Medical Management<br>Continued medical management restricted to exclude interventional pain treatments | |
| Active Comparator: Axium Group<br>As the CMM group but also treated with Dorsal Root Ganglion stimulation using the Axium neurostimulator | Device: Implantation with the commercially available Axium neurostimulator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |