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

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

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).

Study Overview

• Status: Terminated
• Conditions: Chronic Inguinal Pain Refractory to Previous Surgical Intervention (Neurectomy)
• Intervention / Treatment: Device: Implantation with the commercially available Axium neurostimulator

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Eindhoven, Netherlands
    • Maxima Medisch Centrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Conservative Medical Management; Continued medical management restricted to exclude interventional pain treatments
ACTIVE_COMPARATOR: Axium Group; As the CMM group but also treated with Dorsal Root Ganglion stimulation using the Axium neurostimulator	Device: Implantation with the commercially available Axium neurostimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Maxima Medical Center

Publications and helpful links

General Publications

• Mol FMU, Roumen RM, Scheltinga MR. Comparing the efficacy of targeted spinal cord stimulation (SCS) of the dorsal root ganglion with conventional medical management (CMM) in patients with chronic post-surgical inguinal pain: the SMASHING trial. BMC Surg. 2018 Mar 27;18(1):18. doi: 10.1186/s12893-018-0349-8.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ANTICIPATED): July 1, 2017
• Study Completion (ANTICIPATED): October 1, 2017

Study Registration Dates

• First Submitted: January 9, 2015
• First Submitted That Met QC Criteria: January 23, 2015
• First Posted (ESTIMATE): January 29, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): February 1, 2017
• Last Update Submitted That Met QC Criteria: January 30, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 24-SMI-2014