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:
2025-12-25 @ 2:21 AM
Ignite Modification Date:
2025-12-25 @ 2:21 AM
NCT ID:
NCT04699734
Eligibility Criteria:
Inclusion Criteria:
* Aged 18 years or older.
* Probably diabetic neuropathy confirmed using the Toronto criteria in a "conservative manner", i.e. three out of three symptoms/signs of neuropathy must be present (sensory neuropathy symptoms, distal reduced sensibility, reduced ankle reflexes) 7.
* Definite or probable neuropathic pain for minimum the last 6 months
* Mean pain intensity at \> 4 NRS the last week17.
Since we expect a large effect of the block it is not necessary to discontinue pain medication.
Exclusion Criteria:
* Other causes of pain in the same area or other pain that cannot be distinguished from the neuropathic pain.
* Unable to understand and speak Danish.
* Non-cooperative.
* Warfarin or other medication that contraindicate regional anesthesia.
* Infection in the injection area.
* Allergy to lidocaine.
* Pregnancy or lactating (fertile women must to show negative pregnancy test or use anticonception).
* Severe psychiatric disease e.g. severe depression during the last 6 months.
* Alcohol or drug abuse.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04699734
Study Brief:
Protocol Section:
NCT04699734