Dorsal Root Ganglion Stimulation as Treatment for Post-surgical Groin Pain

NCT02337699 | Terminated

• 1 other identifier: 25-SMI-2014
• Study Type: observational
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

25-SMI-2014 is a post market observational, questionnaire based study to assess the effectiveness of the Axium neurostimulator as a treatment for chronic post surgical groin pain. Within is also a nested feasibility study to assess the clinical utility of a Quantitive Sensory Testing (QST) protocol in the management of the described study group.

Conditions

Post Surgical Groin Pain

Outcome Measures

Primary Outcomes (2)

• Main Study: Pain Relief - Assessed be Change in Pain Intensity from Pre-Treatment Baseline

  Post implantation at; 1, 3 and 6 months

• Feasibility Study: To determine subject acceptance of the described QST methodology and protocol; assessed using a 5 point Likert scale

  Baseline then Post implantation at; 1, 3 and 6 months

Study Arms (2)

Treated Subjects

All subjects recruited into the main study treated with the Axium neurostimulator

Device: Implantation with the commercially available Axium neurostimulator

QST Group

A sub-set of the main study group who also consent to take part in the Quantitative Sensory Testing based feasibility study

Device: Implantation with the commercially available Axium neurostimulator; Procedure: QST Testing

Interventions

Implantation with the commercially available Axium neurostimulator DEVICE

QST Group; Treated Subjects

QST Testing PROCEDURE

QST Group

Eligibility Criteria

• Age: 18 Years - 18 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Chronic Post Surgical Groin Pain Patients

You may qualify if:

• Male
• Age between \>18 and \<65 years
• Unilateral post surgical groin pain for \>6 months
• Pain localized to the region defined by the anterior superior iliac spine (ASIS), the pubic tubercle, and the groin-gluteal-greater trochanter triangles (3G) point,
• Pain has no surgical indication
• Subjects meet the criteria for SCS implantation as set out in the Dutch Neuromodulation Society Guideline
• Pain characterized by neuropathy and/or allodynia
• Average daily baseline pain intensity baseline VAS greater than or equal to 50 mm on a 100mm VAS scale
• Patient willing and able to give informed consent and to participate in observational study

You may not qualify if:

• Inability to speak/read Dutch
• Bilateral and/or recurrent hernia.
• Radiofrequency or injection therapy at or close to a target DRG in the 90 days prior to enrolment
• Current illicit drug use and/or alcohol dependence
• Active infection, or conditions or indwelling devices that pose an increased risk of infection
• Active implantable device including implantable cardiac defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
• Participation in another clinical study during the study period.
• Any other disorder, condition, or circumstance that, in the opinion of the principal investigator, represents a risk to successful completion of all study activities.
• Additional Criteria for nested feasibility study
• Participation in the observational study
• Sign off for sub-study on patient informed consent
• \. For sub-study participation only: pain conditions \[aside from the post surgical groin pain to be treated\], extensive scar tissue, skin conditions, or sensorimotor abnormalities in the areas for QST assessments: the painful groin, the contralateral groin, the ipsilateral arm, and the contralateral hand

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

St Antonius Ziekenhuis

Nieuwegein, Netherlands

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 14, 2015
• Study Start: January 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: February 4, 2019

Record last verified: 2019-01

Locations

NL (1)