Post Surgical Groin Pain
Conditions
Brief summary
15-SMI-2013 is a post market, observational, questionnaire based study to assess the effectiveness of the commercially available Axium neurostimulator in the management of chronic post surgical groin pain
Interventions
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The patient is at least 18 years old 2. The patient is willing and able to comply with the examination schedule and the trial schedule. 3. The patient has suffered from chronic post-surgical neuropathic groin pain for at least 6 months 4. Conservative treatments of the chronic pain including medication, physiotherapy and interventions have been exhausted 5. The pain level at the time of the baseline examination is at least 60mm on the visual analogue scale (VAS) in the primary pain area (groin pain) 6. The patient is able to give consent in writing
Exclusion criteria
1. Pregnant or breastfeeding patients or those who plan to become pregnant during the study 2. It has been established in an examination by the tester that the pain has significantly worsened or changed its characteristics in the course of the previous month. 3. In the last 30 days, the patient has been treated with corticosteroids on an area scheduled for the stimulation. 4. In the last 3 months, the patient has been treated with radio frequency therapy on an area scheduled for the stimulation. 5. The patient has already been treated with an active implantable device, including an implantable cardioverter defibrillator, pacemaker, spinal cord stimulator or an intrathecal medication pump. 6. The patient is not able to operate the stimulation device 7. The patient is currently suffering from an infection 8. The patient has participated in another clinical study in the last 30 days 9. The patient has a coagulation disorder or is taking anti-coagulants, which would make participation impossible, as per the study doctor 10. The patient has been diagnosed with a malignancy in the past 2 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Relief - Assessed by Change in Pain Intensity Assessed using a Visual Analogue Scale (VAS) from Pre-Treatment Baseline | Post treatment at; 1 week and 1, 3, 6 and12 months |
Countries
Germany
Outcome results
None listed