Dorsal root ganglion stimulation as treatment for postsurgical groin pain (GASPA study)

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 20

Inclusion Criteria

Inclusion Criteria Observational study
1. Male
2. Age inclusive and between 18 and 65
3. Unilateral post surgical groin pain for 6 months or more
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 (Appendix B)
7. Pain characterized by neuropathy and/or allodynia
8. Average daily baseline pain intensity 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;Additional Inclusion criteria for nested feasibility study
1. Participation in the observational study
2. Sign off for sub-study on patient informed consent

Exclusion Criteria

Exclusion Criteria Observational study
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 Exclusion 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Observational study<br /><br>* To report the number (percentage) of subjects who describe a reduction in<br /><br>pain intensity of 50% at 6 months post implant as compared to baseline on a<br /><br>visual analogue scale (VAS) and the average reduction in pain intensity for the<br /><br>observed cohort.<br /><br><br /><br>Optional feasibility study<br /><br> To determine subject acceptance of the described QST methodology and<br /><br>protocol; assessed using a 5 point Likert scale.<br /><br>* To characterize adverse events due to QST during the study period.</p><br>

Secondary Outcome Measures