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Chronic Pain, Opioid Use, and Epidermal Nerve Fiber Density

CompletedNCT04801498
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

This pilot study is being performed to examine whether epidermal axons are altered in patients taking opioid therapy for chronic non-cancer pain, and if epidermal axonal changes predict heightened pain sensitivity.

Study details

Official title
Chronic Opioid Use and Epidermal Nerve Fiber Density
Conditions
Sponsor
University of Kansas Medical Center
Start date
2020-12-07
Primary completion
2024-06-25
Sex
All
Age range
from 18 Years to 65 Years
Healthy volunteers
true
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: Healthy/All: * Informed consent provided by the participant * Able to read and speak in English * Age 18 to 65 years * Likely to participate in all scheduled evaluations and study procedures IF they are a Chronic Non-Cancer Patients who do NOT take opioid medication they must meet all of the above criteria as well as: Diagnosis of non-cancer chronic pain syndrome (persistent pain lasting longer than 3 months) IF they are a Chronic Non-Cancer Patients who DO take opioid medication they must meet all of the above criteria as well as: * Chronic daily opioid use for longer than 3 months duration * Stable doses of opioid medications for at least 30 days prior to study visit Exclusion Criteria: * Pregnancy * Prisoner * Current clinically significant cardiac, or neurologic disease * Significant skin disorders in lower extremities * Circulatory insufficiency * Open wounds in lower extremity that may interfere with healing * Lidocaine allergy * Currently taking anticoagulation (e.g., Coumadin, Plavix, etc) * Current litigation for chronic pain * Active psychotic or suicidal symptoms * Current drug or alcohol abuse * Neuropathy in upper extremities (hands specifically, PI discretion). * Current or recent use of artificial fingernails or nail enhancements (last 6 months) * Other diagnoses that are not considered minor/stable (PI discretion) * Current or previous cancer diagnosis * Current or previous chemotherapy treatment * No chronic pain conditions (healthy) * Opioid use in the last year (healthy \& non-opioid pts)

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT04801498