NCT06139510Recruiting
Predictors of Pain in Sickle Cell Disease
Predictors of Pain Severity and Pain-Related Outcomes in Individuals With Sickle Cell Disease
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 70 (estimated)
- First submitted
- 15 Nov 2023
- Start date
- 12 Jul 2024
- Primary completion date
- Jun 2028
- Lead sponsor
- Duke University
- Diseases
- Sickle cell disease
- NCT number
- NCT06139510
What you commit to
- Study type: Interventional
- Planned participants: 70
- From 12 Jul 2024 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Participants with history of a stroke with ongoing physical impairment that prevents participation in study procedures.
- 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
Age
- Age less than 15 or greater than 40 years
Other
- Participants lacking the cognitive or mental capacity to assent to and complete study procedures
- Pregnant females
Who the study is looking for
- 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.
Criteria the registry did not label
- 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).
Age in the registry: 15 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Duke University Medical Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.