Ignite Creation Date:
2024-05-06 @ 3:54 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04801498
Status:
RECRUITING
Last Update Posted:
2023-12-05
First Post:
2021-03-11
Brief Title:
Chronic Pain Opioid Use and Epidermal Nerve Fiber Density
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
Chronic Opioid Use and Epidermal Nerve Fiber Density
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COED
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 pain sensitivity
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 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 eg 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 we postulate that chronic opioid use in patients with chronic pain due to non- cancer conditions 1 contributes to detrimental changes in epidermal axons 2 works against pain-relieving actions of opioids to reduce pain and 3 is possibly linked to opioid-induced hyperalgesia
Our short-term goals are to determine if epidermal axons are altered in patients taking opioid therapy for chronic non-cancer pain and if epidermal axonal changes predict heightened pain sensitivity This pilot study will test whether changes in epidermal axons are dose-dependent in patients taking low-dose moderate-dose or high-dose opioid therapy Our long-term goals will determine whether dose-reduction or cessation of opioids can reverse axonal changes or whether these adverse chances can be prevented with other medications Our central hypothesis is that patients on opioid therapy for chronic non-cancer pain will exhibit elevated epidermal axon densities and these elevations are accompanied with hyperalgesia and allodynia
Aim 1 Do patients on long-term opioid therapy have abnormal intraepidermal nerve fiber IENF density We hypothesize that patients taking chronic opioids for non-cancer pain conditions will exhibit abnormal epidermal nerve fiber density compared to chronic pain patients not taking opioid therapy and healthy controls We will recruit 20 patients with chronic pain due to non-cancer conditions on opioid therapy 20 patients with chronic pain not taking opioid therapy and 20 healthy controls and perform a skin biopsy on the ankle The skin biopsy will then be assessed to ascertain IENF density and compared to normative density values for sex and age Next we will compare quantitative measurements of IENF density to total daily oral morphine equivalents OME taken by the patients We hypothesize that higher daily opioid consumption will correlate with abnormalities in epidermal innervation
Aim 2 Do patients on long-term opioid therapy have heightened cutaneous pain sensitivity that correlates with IENF density We will perform quantitative sensory testing QST in all patient cohorts to objectively assess pain sensitivity Patients will undergo QST for pressure pain threshold temporal summation and conditioned pain modulation We will determine whether heightened pain sensitivity as evidenced by reduced pressure pain thresholds increased temporal summation and reduced conditioned pain modulation is associated with altered IENF from skin biopsies We hypothesize that heightened pain sensitivity will correlate with reductions in epidermal innervation and that higher daily opioid consumption in chronic pain patients will correlate with abnormalities in epidermal innervation and altered QST parameters
Quantitative analysis of cutaneous innervation of the epidermis provides an indication of the health of peripheral sensory axons Studies in various pain conditions eg 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 we postulate that chronic opioid use in patients with chronic pain due to non- cancer conditions 1 contributes to detrimental changes in epidermal axons 2 works against pain-relieving actions of opioids to reduce pain and 3 is possibly linked to opioid-induced hyperalgesia
Our short-term goals are to determine if epidermal axons are altered in patients taking opioid therapy for chronic non-cancer pain and if epidermal axonal changes predict heightened pain sensitivity This pilot study will test whether changes in epidermal axons are dose-dependent in patients taking low-dose moderate-dose or high-dose opioid therapy Our long-term goals will determine whether dose-reduction or cessation of opioids can reverse axonal changes or whether these adverse chances can be prevented with other medications Our central hypothesis is that patients on opioid therapy for chronic non-cancer pain will exhibit elevated epidermal axon densities and these elevations are accompanied with hyperalgesia and allodynia
Aim 1 Do patients on long-term opioid therapy have abnormal intraepidermal nerve fiber IENF density We hypothesize that patients taking chronic opioids for non-cancer pain conditions will exhibit abnormal epidermal nerve fiber density compared to chronic pain patients not taking opioid therapy and healthy controls We will recruit 20 patients with chronic pain due to non-cancer conditions on opioid therapy 20 patients with chronic pain not taking opioid therapy and 20 healthy controls and perform a skin biopsy on the ankle The skin biopsy will then be assessed to ascertain IENF density and compared to normative density values for sex and age Next we will compare quantitative measurements of IENF density to total daily oral morphine equivalents OME taken by the patients We hypothesize that higher daily opioid consumption will correlate with abnormalities in epidermal innervation
Aim 2 Do patients on long-term opioid therapy have heightened cutaneous pain sensitivity that correlates with IENF density We will perform quantitative sensory testing QST in all patient cohorts to objectively assess pain sensitivity Patients will undergo QST for pressure pain threshold temporal summation and conditioned pain modulation We will determine whether heightened pain sensitivity as evidenced by reduced pressure pain thresholds increased temporal summation and reduced conditioned pain modulation is associated with altered IENF from skin biopsies We hypothesize that heightened pain sensitivity will correlate with reductions in epidermal innervation and that higher daily opioid consumption in chronic pain patients will correlate with abnormalities in epidermal innervation and altered QST parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None