Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04699734

Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy

Led by University of Aarhus · Updated on 2021-01-07

16

Participants Needed

1

Research Sites

329 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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.

Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Danish Pain Research Center, Aarhus University, Aarhus University Hospital

Aarhus N, Jutland, Denmark, 8200

Actively Recruiting

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Research Team

E

Ellen L Schaldemose, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy | DecenTrialz