NCT02349659

Brief Summary

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 9, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

February 1, 2017

Status Verified

January 1, 2017

Enrollment Period

2.6 years

First QC Date

January 9, 2015

Last Update Submit

January 30, 2017

Conditions

Chronic Inguinal Pain Refractory to Previous Surgical Intervention (Neurectomy)

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Conservative Medical Management

NO INTERVENTION

Continued medical management restricted to exclude interventional pain treatments

Axium Group

ACTIVE COMPARATOR

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

Device: Implantation with the commercially available Axium neurostimulator

Interventions

Implantation with the commercially available Axium neurostimulatorDEVICE
Axium Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 Open Inguinal Hernia Repair for at least 6 months
  • Previously undergone neurectomy procedure as a treatment for chronic inguinal pain
  • Minimum daily average baseline pain rating of 5 out of 10 in the inguinal area on an 11-point NPRS
  • Subject is able to provide written informed consent
  • Subject has been screened by a multi-disciplinary panel including the designated psychologist of the Máxima Medical Center and deemed suitable for implantation

You may not qualify if:

  • 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 implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
  • Subject is unable to operate the device
  • Subjects 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 on going 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 has been diagnosed with cancer in the past 2 years, except for skin malignancies.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Máxima Medisch Centrum

Eindhoven, Netherlands

Location

Related Publications (2)

  • Mol F, Scheltinga M, Roumen R, Wille F, Gultuna I, Kallewaard JW, Elzinga L, van de Minkelis J, Nijhuis H, Stronks DL, Huygen FJPM. Comparing the Efficacy of Dorsal Root Ganglion Stimulation With Conventional Medical Management in Patients With Chronic Postsurgical Inguinal Pain: Post Hoc Analyzed Results of the SMASHING Study. Neuromodulation. 2023 Dec;26(8):1788-1794. doi: 10.1016/j.neurom.2022.09.014. Epub 2022 Nov 29.

    PMID: 36456417DERIVED

  • 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.

    PMID: 29587729DERIVED

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
drs.

Study Record Dates

First Submitted

January 9, 2015

First Posted

January 29, 2015

Study Start

December 1, 2014

Primary Completion

July 1, 2017

Study Completion

October 1, 2017

Last Updated

February 1, 2017

Record last verified: 2017-01

Locations

NL(1)