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Nerve block to study pain signals in painful diabetic nerve damage

Tests whether numbing nerves in the limbs changes spontaneous pain in diabetic polyneuropathy.

Key facts

Who runs it
University of Aarhus
Where
Denmark1 site in 1 countryChoose a country to see its sites
Trial code
Registry title
Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy
Status
Recruiting
People taking part
16 people, planned
Started
8 Sept 2020
Expected to end
31 Dec 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Xylocaine 1%
  • NaCl 9mg/ml
Record updated
7 January 2021

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with painful nerve damage from diabetes (diabetic polyneuropathy). It tests a numbing nerve block to see how much the nerves in the limbs drive the pain.

Age
18 years or older
Sex
All sexes
Disease stage
Diabetic nerve damage confirmed by the Toronto criteria, with all three signs: nerve symptoms, reduced feeling in the feet or hands, and weaker ankle reflexes. Definite or probable nerve pain for at least the last 6 months. Average pain score above 4 (NRS pain scale) over the last week.
Earlier treatment
People do not need to stop their pain medicine.

Main reasons for not taking part

  • Other pain in the same area, or pain that cannot be told apart from the nerve pain
  • Taking warfarin or other medicine that rules out a local numbing injection, or an infection where the injection goes
  • Allergy to lidocaine
  • Pregnant or breastfeeding women. Women who can become pregnant need a negative pregnancy test or must use birth control
  • Severe mental illness, such as severe depression in the last 6 months, alcohol or drug abuse, or not able to understand and speak Danish

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Warfarin or other medication that contraindicate regional anesthesia
  • Alcohol or drug abuse
  • Infection in the injection area
  • Allergy to lidocaine
  • Severe psychiatric disease e.g. severe depression during the last 6 months
  • 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
  • Pregnancy or lactating (fertile women must to show negative pregnancy test or use anticonception)

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • XylocaineExisting treatment, for comparison

    Nerve block

    Treatment: Xylocaine 1%

  • Isotonic salinePlacebo, for comparison

    Nerve block

    Treatment: NaCl 9mg/ml

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy: How Important is the Peripheral Signaling?
Plain-language title
Nerve block to study pain signals in painful diabetic nerve damageGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 15 November 2026.
Record updated
7 January 2021