Chronic Pain, Opioid Use, and Epidermal Nerve Fiber Density

NCT04801498 | Completed

• 1 other identifier: STUDY00144620
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Pain; Opioid Use; Nerve Disorders

Outcome Measures

Primary Outcomes (1)

• IENFD

  Intraepidermal Nerve Fiber Density

  Baseline

Secondary Outcomes (16)

• Fibromyalgianess

  Baseline

• Clinical Pain Severity

  Baseline

• Neuropathic Pain Descriptors

  Baseline

• Stress

  Baseline

• Catastrophizing

  Baseline

Study Arms (3)

Healthy controls

Men and women ages 18-65 years old with no major medical problems and no history of chronic pain or opioid use.

Chronic pain patients not taking opioids

Diagnosis of non-cancer chronic pain syndrome (persistent pain lasting longer than 3 months) that have not used any opioid medication within the past one year.

Chronic pain patients taking opioids

Diagnosis of non-cancer chronic pain syndrome (persistent pain lasting longer than 3 months) using chronic daily opioid use for longer than 3 months duration and taking stable doses of opioid medications for at least 30 days prior to study visit.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A cross-sectional study will recruit a total of 60 men and women in three cohorts (20 each): 1) chronic non-cancer pain patients who are utilizing long-term (greater than 3 months of daily use) opioid medication to treat their chronic pain conditions, 2) chronic non-cancer pain patients who do not take opioid medications, and 3) healthy controls.

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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Health System

Kansas City, Kansas, 66160, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cheek swab

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrea L Chadwick, MD, MSc, FASA

  University of Kansas School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 17, 2021
• Study Start: December 7, 2020
• Primary Completion: June 25, 2024
• Study Completion: June 25, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

US (1)