Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-24 @ 11:32 PM
NCT ID:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02346656
Study Brief:
Protocol Section:
NCT02346656