NCT04699734 Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy
| NCT ID | NCT04699734 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Aarhus |
| Condition | Painful Diabetic Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2020-09-08 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 16 participants in total. It began in 2020-09-08 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the present study is to evaluate the role of peripheral afferent input for spontaneous pain in painful diabetic polyneuropathy
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.
Contact & Investigator
Ellen L Schaldemose, MD
PRINCIPAL INVESTIGATOR
Danish Pain Research Center, Aarhus University
Frequently Asked Questions
Who can join the NCT04699734 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Painful Diabetic Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04699734 currently recruiting?
Yes, NCT04699734 is actively recruiting participants. Contact the research team at ells@clin.au.dk for enrollment information.
Where is the NCT04699734 trial being conducted?
This trial is being conducted at Aarhus N, Denmark.
Who is sponsoring the NCT04699734 clinical trial?
NCT04699734 is sponsored by University of Aarhus. The principal investigator is Ellen L Schaldemose, MD at Danish Pain Research Center, Aarhus University. The trial plans to enroll 16 participants.