Diabetic neuropathies: update on definitions, diagnostic criteria, estimation of severity, and treatments.
Solomon Tesfaye, Andrew J M Boulton, Peter J Dyck...
https://pubmed.ncbi.nlm.nih.gov/20876709Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID04699734
Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy: How Important is the Peripheral Signaling?
Led by University of Aarhus · Updated on 2021-01-07
16
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the role of peripheral nerve signals in causing spontaneous pain in people with painful diabetic polyneuropathy. This condition involves nerve damage related to diabetes that results in ongoing pain, and both peripheral and central nervous system changes may contribute to this pain. The study aims to better understand how these nerve changes influence pain in affected individuals. The study compares two types of nerve block treatments: one using Xylocaine 1% and the other using isotonic saline (saltwater) as a placebo. Both treatments involve a nerve block procedure applied to relieve pain in the affected area. Participants are randomly assigned to one of these groups in a double-blind setup, meaning neither participants nor researchers know which treatment is given during the study. Participants will be monitored closely for pain relief and changes in pain intensity at multiple time points up to 90 minutes after the nerve block. Researchers will assess spontaneous pain, hyperalgesia (increased sensitivity to pain), allodynia (pain from normally non-painful stimuli), and the distribution of evoked pain. The study includes various questionnaires and measurements to track these pain symptoms and their relief during the short observation period.
CONDITIONS
Brief Title
Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Probable diabetic neuropathy confirmed by three symptoms/signs: sensory neuropathy symptoms, distal reduced sensibility, and reduced ankle reflexes
- Definite or probable neuropathic pain lasting at least 6 months
- Mean pain intensity above 4 on numerical rating scale in the past week
You will not qualify if you...
- Other causes of pain in the same area or pain indistinguishable from neuropathic pain
- Unable to understand or speak Danish
- Non-cooperative behavior
- Use of warfarin or medications contraindicating regional anesthesia
- Infection at injection site
- Allergy to lidocaine
- Pregnancy or lactation without negative pregnancy test or contraception use
- Severe psychiatric disease such as severe depression within last 6 months
- Alcohol or drug abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Approximately 90 minutes per session
Participants receive peripheral regional nerve blocks with either Xylocaine or isotonic saline to evaluate pain relief in painful diabetic polyneuropathy.
1 to 2 visits depending on crossover schedule
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
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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