Status:
RECRUITING
Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy
Lead Sponsor:
University of Aarhus
Conditions:
Painful Diabetic Neuropathy
Neuropathic Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the present study is to evaluate the role of peripheral afferent input for spontaneous pain in painful diabetic polyneuropathy
Detailed Description
Both peripheral and central changes in the nervous system contribute to the development of painful diabetic neuropathy, but how these changes contribute to the pain generation remains yet to be fully ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04699734
Start Date
September 8 2020
End Date
December 31 2026
Last Update
January 7 2021
Active Locations (1)
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1
Danish Pain Research Center, Aarhus University, Aarhus University Hospital
Aarhus N, Jutland, Denmark, 8200