Peripheral nerve block for painful diabetic neuropathy
Peripheral Nerve Block in Patients With Painful Diabetic Polyneuropathy: How Important is the Peripheral Signaling?
This study is testing if a nerve block can help adults with painful diabetic neuropathy feel less pain without stopping their regular medications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 16 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Aarhus Academic / other |
| Locations | 1 site (Aarhus N, Jutland) |
| Trial ID | NCT04699734 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed painful diabetic neuropathy and a pain intensity rating above 4 on the NRS scale.
Not a fit: Patients with other identifiable causes of pain, severe psychiatric conditions, or contraindications to regional anesthesia may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly alleviate pain for patients suffering from diabetic neuropathy.
How similar studies have performed: While similar approaches have been explored, the specific application of peripheral nerve blocks for this condition remains novel and under-researched.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aarhus N, Jutland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.