Chronic Pain, Opioid Use, and Epidermal Nerve Fiber Density

Completed

Conditions studied: Chronic Pain, Opioid Use, Nerve Disorders

In brief

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.

Key facts

Study ID

NCT04801498

Run by

University of Kansas Medical Center

People needed

38

Starts

2020-12-07

Expected to finish

2024-06-25

Last updated by the study team

2024-11-06

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• University of Kansas Health System — Kansas City, Kansas, United States

Full record on ClinicalTrials.gov

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