US Medical Center conducts a clinical trial of Chronic Pain, Opioid Use, and Epidermal Nerve Fiber Density

Photo by Taylor Deas-Melesh

The University of Kansas Medical Center is enrolling patients into the clinical trial investigating Chronic Pain, Opioid Use, and Epidermal Nerve Fiber Density (COED).

This 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.

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 associated negative costs. Prescription opioid use leads to increased mortality due to unintentional overdose, misuse and abuse, transition into illicit opioid use, decreased pain thresholds, and widespread neuropathic pain. In addition, opioid- induced hyperalgesia is a dangerous and paradoxical condition wherein patients on opioids develop increased super- heightened pain. In the USA, the increase in prescription opioid use has followed a similar trajectory of the incidence of overdose due to prescription and illicit opioids. Sadly, even with this drastic escalation in opioid use, there has been no change in the rate or severity of chronic pain conditions.

Quantitative analysis of cutaneous innervation of the epidermis provides an indication of the health of peripheral sensory axons. Studies in various pain conditions (e.g., painful diabetic neuropathy, painful chemotherapy-induced neuropathy, and fibromyalgia) suggest changes in epidermal innervation may underlie pain in the feet and hands. Our preclinical studies reveal that changes in epidermal axons play a key role in the development of pain. Here, investigators postulate that chronic opioid use in patients with chronic pain due to non- cancer conditions:

• contributes to detrimental changes in epidermal axons
• works against pain-relieving actions of opioids to reduce pain
• is possibly linked to opioid-induced hyperalgesia

The trial is designed to enroll male and female 18 to 65 years and is being conducted in the University of Kansas Health System, Kansas City, Kansas, United States.

The study start date is December 7, 2020.

The population that are excluded from participation:

• 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

and others.

This page provides a more detailed overview of this clinical trial: https://ichgcp.net/clinical-trials-registry/NCT04801498