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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 15
Maximum Age: 40
Healthy Volunteers: f
View:

• 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.

Locations
United States
North Carolina
Duke University Medical Center
RECRUITING
Durham
Contact Information
Primary
Martha Kenney, MD
martha.kenney@duke.edu
9196814877
Backup
Nirmish Shah, MD
nirmish.shah@duke.edu
1919 668 5178
Time Frame
Start Date: 2024-07-12
Estimated Completion Date: 2028-06
Participants
Target number of participants: 70
Treatments
Other: Individuals living with sickle cell disease
Participants living with sickle cell disease 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.
Sponsors
Leads: Duke University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov