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

Terminated

• Conditions: Post Surgical Groin Pain
• Interventions: Device: Implantation with the commercially available Axium neurostimulator; Procedure: QST Testing

• Registration Number: NCT02337699
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-09
• Study First Submitted QC: 2015-01-09
• Study First Posted: 2015-01-14
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-31
• Last Update Posted: 2019-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 1

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treated Subjects	Implantation with the commercially available Axium neurostimulator	All subjects recruited into the main study treated with the Axium neurostimulator
QST Group	Implantation with the commercially available Axium neurostimulator	A sub-set of the main study group who also consent to take part in the Quantitative Sensory Testing based feasibility study
QST Group	QST Testing	A sub-set of the main study group who also consent to take part in the Quantitative Sensory Testing based feasibility study

Primary Outcome Measures

Name	Time	Method
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
Main Study: Pain Relief - Assessed be Change in Pain Intensity from Pre-Treatment Baseline	Post implantation at; 1, 3 and 6 months

Trial Locations

Locations (1)

St Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands