Post Surgical Groin Pain
Conditions
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.
Interventions
PROCEDUREQST Testing
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| 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 |
Countries
Netherlands
Outcome results
None listed