NCT06139510

Predictors of Pain in Sickle Cell Disease

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 15 Years – 40 Years
• Healthy volunteers: Not accepted

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).

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 managing SCD pain because of the poor understanding of the etiology of chronic/persistent SCD pain and the absence of validated clinical predictive tools that can accurately identify individuals with SCD who are at risk of developing severe, persistent pain with associated physical and/or psychological disability. The overall objective of this study is to identify predictors of pain severity and pain-related outcomes in SCD using a prospective, longitudinal study design. This proposal is supported by the hypothesis that pain-specific psychological and sensory factors are strong, modifiable predictors of SCD pain severity and pain-related outcomes. The understanding of pain-specific psychological and sensory predictors of SCD pain outcomes is anticipated to have important implications for (1) identifying SCD patients who are at risk for severe pain outcomes, (2) informing preventive and therapeutic management of SCD pain, and (3) selecting patients for clinical trials of non-opioid interventions for SCD pain. The hypothesis will be tested by pursuing two specific aims: Aim 1) Determine psychological predictors of pain outcomes; and Aim 2) Ascertain the strength of pain distribution and sensitivity as predictors of pain outcomes. The researchers will use reliable and well validated pain-specific patient-reported outcome (PRO) questionnaires to evaluate the strength of psychological factors for predicting pain severity and other pain-related outcomes in the study cohort (Aim 1) and will use body mapping and quantitative sensory testing (QST) to examine sensory predictors of pain outcomes (Aim 2).

Conditions

• Sickle Cell Disease
• Chronic Pain

Interventions

Type	Name	Description
OTHER	Quantitative sensory testing	Quantitative sensory testing is a standard type of pain testing that measures changes in sensitivity to different type of sensations that include temperature, touch or pressure.

Timeline

• Start date: 2024-07-12
• Primary completion: 2028-06-01
• Completion: 2028-06-01
• First posted: 2023-11-18
• Last updated: 2026-01-20

Locations

1 site across 1 country: United States