Status:
RECRUITING
Predictors of Pain in Sickle Cell Disease
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sickle Cell Disease
Chronic Pain
Eligibility:
All Genders
15-40 years
Phase:
NA
Brief 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 o...
Detailed Description
Severe, disabling pain is the hallmark of sickle cell disease (SCD). SCD pain is associated with poor quality of life, early mortality, and high healthcare costs. Clinicians face great challenges in m...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT06139510
Start Date
July 12 2024
End Date
June 1 2028
Last Update
September 19 2024
Active Locations (1)
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1
Duke University Medical Center
Durham, North Carolina, United States, 27710