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

NCT ID: NCT02337699

Last Updated: 2019-02-04

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-09-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Treated Subjects

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

Implantation with the commercially available Axium neurostimulator

Intervention Type: DEVICE

QST Group

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

Implantation with the commercially available Axium neurostimulator

Intervention Type: DEVICE

QST Testing

Intervention Type: PROCEDURE

Interventions

Implantation with the commercially available Axium neurostimulator

Intervention Type: DEVICE

QST Testing

Intervention Type: PROCEDURE

Eligibility Criteria

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

1. Participation in the observational study

2. Sign off for sub-study on patient informed consent

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Abbott Medical Devices

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

St Antonius Ziekenhuis

Nieuwegein, , Netherlands

Countries

Netherlands

Other Identifiers

25-SMI-2014

Identifier Type: -

Identifier Source: org_study_id