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Predictors of Pain in Sickle Cell Disease

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
15 Years to 40 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 48 months
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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)."
  • "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)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks for factors that may predict severe pain in people ages 15 to 40 with sickle cell disease. Participants will have a video visit, an in-person visit with pain tests, and short pain surveys every three months for up to four years. The goal is to help improve pain care and guide future studies of treatments without opioids.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be 15 to 40 years old.
  • You must have a confirmed diagnosis of sickle cell disease.
  • You must have had at least one sickle cell pain episode treated with opioids, strong pain medicines, at home or in a hospital in the past 12 months.
  • If you take pain medicines regularly, your dose must have stayed the same for at least four weeks before joining.
  • Adults must give written consent to join. People younger than 18 must have a parent's consent.

Who can't join

  • You are younger than 15 or older than 40.
  • You cannot understand and agree to join or complete the study tasks.
  • You are pregnant.
  • You have lasting physical problems from a stroke that prevent you from doing the study tasks.
  • You had a severe sickle cell pain crisis that led to an emergency room visit or hospital stay in the two weeks before joining.
  • You currently have an infection.
  • The study doctor finds a condition that could prevent you from taking part or affect the results, such as nerve damage or bone tissue death that needs pain treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (1)

NC