Peripheral nerve block for painful diabetic neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a peripheral regional nerve block in relieving spontaneous pain associated with painful diabetic polyneuropathy. It aims to understand the role of peripheral afferent input in pain generation by administering Xylocaine 1% and NaCl to participants. The study includes adults aged 18 and older who have confirmed diabetic neuropathy and have experienced neuropathic pain for at least six months. Participants will not need to discontinue their pain medications during the study.

Why it matters

Who can join: the full rules

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.

Where it's running

• Danish Pain Research Center, Aarhus University, Aarhus University Hospital
  Aarhus N, Jutland, Denmark Recruiting

Study contacts

• Principal investigator: Ellen L Schaldemose, MD — Danish Pain Research Center, Aarhus University
• Study coordinator: Ellen L Schaldemose, MD
• Email: ells@clin.au.dk
• Phone: +45 93501942

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.