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

Maxima Medical Center

Status: Terminated

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

Treatments: Device: Implantation with the commercially available Axium neurostimulator

Study type: Interventional

Funder types: Other

Identifiers

NCT02349659

24-SMI-2014

Details and patient eligibility

About

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).

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject is at least 18 years old
2. Subject is able and willing to comply with the follow-up schedule and protocol
3. Chronic inguinal pain following Pfannenstiel Incision or Open Inguinal Hernia Repair for at least 6 months
4. Previously undergone neurectomy procedure as a treatment for chronic inguinal pain
5. Minimum daily average baseline pain rating of 5 out of 10 in the inguinal area on an 11-point NPRS
6. Subject is able to provide written informed consent
7. Meets of the inclusion criteria for the implantation of a neurostimulation system as set out by the Dutch Neuromodulation Society
8. 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

1. Female subject of childbearing potential is pregnant/nursing or plans to become pregnant during the course of the Trial
2. Escalating or changing pain condition within the past month as evidenced by investigator examination
3. Subject has had injection therapy or radiofrequency treatment of a target neural structure within the past 3 months
4. Subject currently has an active implantable device including implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
5. Subject is unable to operate the device
6. Subjects currently has an active infection
7. Subject has participated in another clinical investigation within 30 days
8. Subject has a coagulation disorder or uses anticoagulants that, in the opinion of the investigator, precludes participation
9. Subject has a current or on going condition, which will probably require MRI investigation sometime in the following 2 years
10. Subject has had a spinal surgical procedure at or between vertebral levels T10-L2
11. Subject has been diagnosed with cancer in the past 2 years, except for skin malignancies.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Conservative Medical Management

No Intervention group

Description:

Continued medical management restricted to exclude interventional pain treatments

Axium Group

Active Comparator group

Description:

As the CMM group but also treated with Dorsal Root Ganglion stimulation using the Axium neurostimulator

Treatment:

Device: Implantation with the commercially available Axium neurostimulator