Identifying Pain Predictors in Sickle Cell Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to identify factors that predict severe pain outcomes in individuals with sickle cell disease (SCD) to enhance pain management strategies. Participants will undergo a virtual assessment followed by an in-person visit where they will complete surveys and quantitative sensory testing to evaluate their pain response. The study focuses on understanding psychological and sensory predictors of pain severity, which could lead to better identification of patients at risk for severe pain and inform future non-opioid treatment options.

Why it matters

Who can join: the full rules

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

Where it's running

• Duke University Medical Center
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Martha Kenney, MD — Duke University
• Study coordinator: Martha Kenney, MD
• Email: martha.kenney@duke.edu
• Phone: 9196814877

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.