Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy

Recruiting now · Not applicable

Conditions studied: Painful Diabetic Neuropathy, Neuropathic Pain, Neuropathy;Peripheral

In brief

The purpose of the present study is to evaluate the role of peripheral afferent input for spontaneous pain in painful diabetic polyneuropathy

Key facts

Study ID

NCT04699734

Run by

University of Aarhus

People needed

16

Starts

2020-09-08

Expected to finish

2026-12-31

Last updated by the study team

2021-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Danish Pain Research Center, Aarhus University, Aarhus University Hospital — Aarhus N, Jutland, Denmark (enrolling)

Full record on ClinicalTrials.gov

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