Status:

COMPLETED

Chronic Pain, Opioid Use, and Epidermal Nerve Fiber Density

Lead Sponsor:

University of Kansas Medical Center

Conditions:

Chronic Pain

Opioid Use

Eligibility:

All Genders

18-65 years

Brief Summary

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 pai...

Detailed Description

Currently, 1 in 25 adults in the USA regularly uses prescription opioids. Now described as a healthcare crisis, increased prescription opioid use is linked with greater healthcare utilization and its ...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

December 7 2020

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

June 25 2024

Estimated Enrollment :

38 Patients enrolled

Trial Details

Trial ID

NCT04801498

Start Date

December 7 2020

End Date

June 25 2024

Last Update

November 6 2024

Active Locations (1)

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1

University of Kansas Health System

Kansas City, Kansas, United States, 66160