Dorsal Root Ganglion Stimulation as Treatment for Post-surgical Groin Pain

Study Overview
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Brief Summary
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25-SMI-2014 is a post market observational, questionnaire based study to assess the effectiveness of the Axium neurostimulator as a treatment for chronic post surgical groin pain. Within is also a nested feasibility study to assess the clinical utility of a Quantitive Sensory Testing (QST) protocol in the management of the described study group.

Official Title
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DORSAL ROOT GANGLION STIMULATION AS TREATMENT FOR POSTSURGICAL GROIN PAIN (GASPA Study)

Conditions
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Post Surgical Groin Pain

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


Participation Criteria
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Eligibility Criteria
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Main Study Inclusion Criteria: Male Age between >18 and <65 years Unilateral post surgical groin pain for >6 months Pain localized to the region defined by the anterior superior iliac spine (ASIS), the pubic tubercle, and the groin-gluteal-greater trochanter triangles (3G) point, Pain has no surgical indication Subjects meet the criteria for SCS implantation as set out in the Dutch Neuromodulation Society Guideline Pain characterized by neuropathy and/or allodynia Average daily baseline pain intensity baseline VAS greater than or equal to 50 mm on a 100mm VAS scale Patient willing and able to give informed consent and to participate in observational study Exclusion Criteria: Inability to speak/read Dutch Bilateral and/or recurrent hernia. Radiofrequency or injection therapy at or close to a target DRG in the 90 days prior to enrolment Current illicit drug use and/or alcohol dependence Active infection, or conditions or indwelling devices that pose an increased risk of infection Active implantable device including implantable cardiac defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump Participation in another clinical study during the study period. Any other disorder, condition, or circumstance that, in the opinion of the principal investigator, represents a risk to successful completion of all study activities. Additional Criteria for nested feasibility study Additional Inclusion Criteria Participation in the observational study Sign off for sub-study on patient informed consent Additional Exclusion Criteria 1. For sub-study participation only: pain conditions [aside from the post surgical groin pain to be treated], extensive scar tissue, skin conditions, or sensorimotor abnormalities in the areas for QST assessments: the painful groin, the contralateral groin, the ipsilateral arm, and the contralateral hand

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treated Subjects<br>All subjects recruited into the main study treated with the Axium neurostimulator | Device: Implantation with the commercially available Axium neurostimulator<br> <br> |
| QST Group<br>A sub-set of the main study group who also consent to take part in the Quantitative Sensory Testing based feasibility study | Device: Implantation with the commercially available Axium neurostimulator<br> <br> Procedure: QST Testing<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main Study: Pain Relief - Assessed be Change in Pain Intensity from Pre-Treatment Baseline |  | Post implantation at; 1, 3 and 6 months | 
| Feasibility Study: To determine subject acceptance of the described QST methodology and protocol; assessed using a 5 point Likert scale |  | Baseline then Post implantation at; 1, 3 and 6 months |