Clinical trial NCT04699734: Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy
Official title: Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy: How Important is the Peripheral Signaling?
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Painful Diabetic Neuropathy
Neuropathic Pain
Neuropathy;Peripheral
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-01-07
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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 understood.

The purpose of this study is to evaluate if a peripheral regional nerve block relieves 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.

Primary outcomes:
measure: Indication of pain relieved extremity
timeFrame: 30 minutes
Secondary outcomes:
measure: Pain intensity
timeFrame: 90 minutes
measure: Hyperalgesia and allodynia
timeFrame: 90 minutes
measure: Pain relief
timeFrame: 45 minutes
measure: Pain symptomps
timeFrame: 50 minutes
measure: Distribution of evoked pain
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Danish Pain Research Center, Aarhus University, Aarhus University Hospital
state: Jutland
Study officials:
affiliation: Danish Pain Research Center, Aarhus University
name: Ellen L Schaldemose, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tesfaye S, Boulton AJ, Dyck PJ, Freeman R, Horowitz M, Kempler P, Lauria G, Malik RA, Spallone V, Vinik A, Bernardi L, Valensi P; Toronto Diabetic Neuropathy Expert Group. Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments. Diabetes Care. 2010 Oct;33(10):2285-93. doi: 10.2337/dc10-1303.