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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04699734
Other study ID # BPN2020
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 8, 2020
Est. completion date December 31, 2026

Study information

Verified date December 2020
Source University of Aarhus
Contact Ellen L Schaldemose, MD
Phone +45 93501942
Email ells@clin.au.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 16
Est. completion date December 31, 2026
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
Xylocaine 1%
Nerve block
NaCl 9mg/ml
Nerve block

Locations

Country Name City State
Denmark Danish Pain Research Center, Aarhus University, Aarhus University Hospital Aarhus N Jutland

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. Review. Erratum in: Diabetes Care. 2010 Dec;33(12):2725. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Indication of pain relieved extremity Number of participants who indicated the leg with lidocaine as most pain relieved 30 minutes after block And number of participants who indicated the leg with saline as most pain relieved 30 minutes after block 30 minutes
Secondary Pain intensity Intensity of spontaneous pain (Numeric Rating Scale (NRS) 0-10, 0=no pain 10=worst pain imaginable) 30, 45, 60 and 90 minutes after block 90 minutes
Secondary Hyperalgesia and allodynia Intensity of hyperalgesia and allodynia from -5 to 5 (-5 = no sensation, 0=normal sensation, 5=extremely intense sensation) to brush, pinprick, cold and warm at baseline and if there is registered any signs of hyperexcitability at baseline then 35, 60 and 90 minutes after nerve block. 90 minutes
Secondary Pain relief Pain relief at 45 minutes after block assessed using a 6-point scale compared to pain intensity at baseline. (-1 = worse pain 0=no relief 1= little 2= moderate 3=good 4=complete) 45 minutes
Secondary Pain symptomps Intensity of neuropathic pain symptoms 50 minutes after nerve block Burning: NRS (0-10), 0=no burning 10=worst burning imaginable Squeezing: NRS (0-10), 0=no squeezing 10=worst squeezing imaginable Pressure: NRS (0-10), 0=no pressure 10=worst pressure imaginable Tingling: NRS (0-10), 0=no tingling 10=worst tingling imaginable 50 minutes
Secondary Distribution of evoked pain The distribution of any evoked pain to brush, pinprick, cold and warm before and 60 minutes after nerve block will be mapped using a filt pen and afterwards photographed. 60 minutes
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