NCT06139510 Predictors of Pain in Sickle Cell Disease

Eligibility & Interventions

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This trial targets 70 participants in total. It began in 2024-07-12 with a primary completion date of 2028-06.

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 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 Criteria

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). Inclusion Criteria: 1. Diagnosis of sickle cell disease (documentation of SS, SC, S beta + thalassemia, S beta + thalassemia) is required 2. 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 3. Participants who are on chronic analgesics (NSAID, acetaminophen) or opioids should be on a stable dose for 4 weeks prior to recruitment. Exclusion Criteria: 1. Age less than 15 or greater than 40 years 2. Participants lacking the cognitive or mental capacity to assent to and complete study procedures 3. Pregnant females 4. Participants with history of a stroke with ongoing physical impairment that prevents participation in study procedures. 5. 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. 6. Current or active infection 7. 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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