Predictors of Pain in Sickle Cell Disease

NCT06139510 | Recruiting

• 2 other identifiers: Pro001120241K01HL169339-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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).

Conditions

Sickle Cell Disease; Chronic Pain

Keywords

quantitative sensory testing; pain sensitization

Outcome Measures

Primary Outcomes (1)

• Change in pain pain severity

  Will be determined by answering the severity subscale of the Brief Pain Inventory

  At baseline and every three months while enrolled in the study, up to 48 months

Secondary Outcomes (4)

• Change in psychological distress

  At baseline and every three months while enrolled in the study, up to 48 months

• Change in pain interference

  At baseline and every three months while enrolled in the study, up to 48 months

• Change in physical function

  At baseline and every three months while enrolled in the study, up to 48 months

• Change in healthcare utilization for pain

  At baseline and every three months while enrolled in the study, up to 48 months

Study Arms (1)

Individuals living with sickle cell disease

OTHER

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.

Other: Quantitative sensory testing

Interventions

Quantitative sensory testing OTHER

All participants enrolled in the study 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. QST is not an intervention, it is a method that is used to assess and understanding pain processing in an individual.

Individuals living with sickle cell disease

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Anemia, Sickle Cell; Chronic Pain

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Martha Kenney, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Martha Kenney, MD

CONTACT

9196814877; martha.kenney@duke.edu

Nirmish Shah, MD

CONTACT

1919 668 5178; nirmish.shah@duke.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This study does not involve drug or biologic products. Masking is non-applicable.
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 18, 2023
• Study Start: July 12, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 5, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)