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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-10-31

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).

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Detailed Description

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Conditions

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Chronic Inguinal Pain Refractory to Previous Surgical Intervention (Neurectomy)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Conservative Medical Management

Continued medical management restricted to exclude interventional pain treatments

Group Type NO_INTERVENTION

No interventions assigned to this group

Axium Group

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

Group Type ACTIVE_COMPARATOR

Implantation with the commercially available Axium neurostimulator

Intervention Type DEVICE

Interventions

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Implantation with the commercially available Axium neurostimulator

Intervention Type DEVICE

Eligibility Criteria

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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
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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No