A randomized controlled trial to evaluate the efficacy of the Spinal Modulation Axium neurostimulator therapy as a treatment for persistent inguinal pain following surgical intervention.

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 78

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 inguinal hernia repair or laparoscopic inguinal repair for at least 6 months.
Previously undergone neurectomy procedure as a treatment for chronic inguinal pain.
Minimum baseline pain rating of 6 out of 10 in the inguinal area on an 11-point NPRS.
Subject is able to provide written informed consent.
Meets 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-disciplanary panel including the designated psychologist of the Máxima Medical Centre Eindhoven and deemed suitable for implantation.
Neuropathic Pain as described by a score of *4 on the DN4 questionnaire

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 ICD, pacemaker, spinal cord stimulator or intrathecal drug pump.
Subject is unable to operate the device.
Subject 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 ongoing 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 had been diagnosed with cancer in the past 2 years, except for skin malignancies
Subject has a significant progressive peripheral or central neurological disorder such as Diabetic Polyneuropathy or Multiple Sclerosis

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The percentage of subjects with *50% pain relief between the two groups and the<br /><br>difference between groups in the change in numerical pain rating scale (NPRS).</p><br>

Secondary Outcome Measures