Identifying Pain Predictors in Sickle Cell Disease

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

This study is trying to find out what factors can predict severe pain in people with sickle cell disease to help improve pain management.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 70 (estimated)
• Ages: 15 Years to 40 Years
• Sex: All
• Sponsor: Duke University (other)
• Locations: 1 site (Durham, North Carolina)
• Trial ID: NCT06139510 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 15 to 40 with a documented diagnosis of sickle cell disease who have experienced at least one pain episode requiring opioid treatment in the past year.

Not a fit: Patients outside the age range of 15 to 40, those lacking cognitive capacity, or individuals with certain medical histories may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved pain management strategies for patients with sickle cell disease.

How similar studies have performed: Other studies have shown promise in identifying pain predictors in chronic pain conditions, suggesting potential for success in this approach.

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

Where this trial is running

Durham, North Carolina

• Duke University Medical Center — Durham, North Carolina, United States (RECRUITING)

Study contacts

• Principal investigator: Martha Kenney, MD — Duke University
• Study coordinator: Martha Kenney, MD

Conditions: Sickle Cell Disease, Chronic Pain, quantitative sensory testing, pain sensitization