RecruitingNot ApplicableNCT06139510

Predictors of Pain in Sickle Cell Disease

Predictors of Pain Severity and Pain-Related Outcomes in Individuals With Sickle Cell Disease

Sponsor

Duke University

Enrollment

70 participants

Start Date

Jul 12, 2024

Study Type

INTERVENTIONAL

Conditions

Chronic Pain Sickle Cell Disease

Summary

Sickle cell disease is a painful inherited disorder that affects approximately 100,000 people in the United States, and more than half of these individuals develop chronic or persistent pain that is often severe and disabling. The factors that predict whether an individual with sickle cell disease will develop severe, disabling pain are unclear. The goal of this project is to identify the factors that predict severe pain outcomes in individuals living with sickle cell disease in order to improve pain management strategies and guide future studies of non-opioid therapies for treatment of their pain. Participants who agree to enroll in this study will be asked to participate in a virtual and then an in-person study visit for their full initial study assessment. They will answer survey questions during the virtual visit, and will be asked to complete several types of standard testing to understand how their body handles pain during the in-person visit. After completing the virtual and in-person sessions, participants will receive text or electronic medical record messages with brief survey (will take less than 8 minutes to complete) on their pain experiences every three months until the study is completed (or up to 48 months for people who are enrolled at the beginning of the study).

Eligibility

Min Age: 15 YearsMax Age: 40 Years

Inclusion Criteria4

All participants must be between 15 and 40 years old and must be able to provide informed, written consent (for adults) or parental consent (for participants younger than 18 years).
Diagnosis of sickle cell disease (documentation of SS, SC, S beta + thalassemia, S beta + thalassemia) is required
Participants must have had at least one sickle cell related pain episode that required treatment with opioids at home or in the hospital 12 months prior to recruitment
Participants who are on chronic analgesics (NSAID, acetaminophen) or opioids should be on a stable dose for 4 weeks prior to recruitment.

Exclusion Criteria7

Age less than 15 or greater than 40 years
Participants lacking the cognitive or mental capacity to assent to and complete study procedures
Pregnant females
Participants with history of a stroke with ongoing physical impairment that prevents participation in study procedures.
Participants with history of severe vaso-occlusive pain crisis resulting in either evaluation in an emergency department or admission to a hospital two weeks prior to study enrollment.
Current or active infection
Any condition that the principle investigator considers would preclude or bias participation in the study, such as (1) neuropathy from diabetes or other causes, (2) active avascular necrosis requiring treatment for pain

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Interventions

OTHERQuantitative sensory testing

All participants enrolled in the study will undergo standardized testing called quantitative sensory testing. Quantitative sensory testing measures changes in sensitivity to different type of sensations that include temperature, touch or pressure. QST is not an intervention, it is a method that is used to assess and understanding pain processing in an individual.