Clinical trial: a BavaRiAn eValuatiOn of Dorsal Root Ganglion (DRG) Stimulation for the Treatment for Chronic Post Surgical Pain of the Groin (NCT02346656)

Eligibility criteria:
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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 49-year-old man comes to the office because of the bulging in his groin.  Physical examination shows a swelling above the inguinal ligament. When the patient is asked to cough, the size of the bulge increases.  His medical history is significant for mild dyslipidemia, which is under control by lifestyle modifications. He does not smoke, but drinks alcohol occasionally. His vital signs and other physical examinations are unremarkable. He is referred to a surgeon and scheduled to undergo elective laparoscopic hernia repair.

Patient description (patient's own words): I'm a 49-year-old man and I went to my doctor the other day because I could not stand that sharp pain in my upper thigh, it was so swollen! The doctor told me that it was swollen right next to my ligament. It's even bigger when I'm coughing. I'm suffering from high cholesterol and I already had to adapt my lifestyle to keep the disease under control. I do not smoke but to be honest I still drink from time to time. The doctor found my vitals normal. She gave me a note to see a surgeon to get my mass removed and get a hernia repair.

Does the patient match the trial criteria? Contradiction