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

Spinal Modulation NV0 个研究点目标入组 20 人开始时间: 待定最近更新: 2024年4月23日

试验速览

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•Inclusion Criteria Observational study
•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 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.

发起方

Spinal Modulation NV