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New treatment option for Painful Diabetic Neuropathy
Official title Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy
ClinicalTrials.gov ID: NCT04699734
What this study is testing
- What it's testing
- The purpose of the present study is to evaluate the role of peripheral afferent input for spontaneous pain in painful diabetic polyneuropathy
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Aarhus N, Jutland, Denmark
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aarhus N, Jutland, Denmark. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.