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

DORSAL ROOT GANGLION STIMULATION AS TREATMENT FOR POSTSURGICAL GROIN PAIN (GASPA Study)

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.

Study Overview

• Status: Terminated
• Conditions: Post Surgical Groin Pain
• Intervention / Treatment: Device: Implantation with the commercially available Axium neurostimulator; Procedure: QST Testing

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• Netherlands
  • Nieuwegein, Netherlands
    • St Antonius Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 18 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Chronic Post Surgical Groin Pain Patients

Description

Main Study

Inclusion Criteria:

1. Male
2. Age between >18 and <65 years
3. Unilateral post surgical groin pain for >6 months
4. 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,
5. Pain has no surgical indication
6. Subjects meet the criteria for SCS implantation as set out in the Dutch Neuromodulation Society Guideline
7. Pain characterized by neuropathy and/or allodynia
8. Average daily baseline pain intensity baseline VAS greater than or equal to 50 mm on a 100mm VAS scale
9. Patient willing and able to give informed consent and to participate in observational study

Exclusion Criteria:

1. Inability to speak/read Dutch
2. Bilateral and/or recurrent hernia.
3. Radiofrequency or injection therapy at or close to a target DRG in the 90 days prior to enrolment
4. Current illicit drug use and/or alcohol dependence
5. Active infection, or conditions or indwelling devices that pose an increased risk of infection
6. Active implantable device including implantable cardiac defibrillator, pacemaker, spinal cord stimulator or intrathecal drug pump
7. Participation in another clinical study during the study period.
8. 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

Additional Inclusion Criteria

1. Participation in the observational study
2. Sign off for sub-study on patient informed consent

Additional Exclusion Criteria

1. 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: January 9, 2015
• First Submitted That Met QC Criteria: January 9, 2015
• First Posted (Estimate): January 14, 2015

Study Record Updates

• Last Update Posted (Actual): February 4, 2019
• Last Update Submitted That Met QC Criteria: January 31, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Cysts; Connective Tissue Diseases; Mucinoses; Ganglion Cysts
• Other Study ID Numbers: 25-SMI-2014