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Behavioural Intervention

Sensory Testing for Sickle Cell Disease

N/A

Recruiting

Led By Martha Kenney, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and every three months while enrolled in the study, up to 48 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to understand why some individuals with sickle cell disease experience severe and disabling pain while others do not. By identifying these factors, researchers hope to improve pain management strategies and explore non-opi

Who is the study for?

This trial is for individuals aged 15-40 with sickle cell disease who've had a pain episode treated with opioids in the past year. They must be on stable pain medication doses for 4 weeks and provide consent (parental if under 18).

What is being tested?

The study aims to identify predictors of severe pain in sickle cell patients to improve management strategies. It involves virtual surveys and in-person quantitative sensory testing, followed by regular brief surveys over up to four years.

What are the potential side effects?

Since this study focuses on non-invasive testing and surveys rather than drug interventions, there are no direct side effects from medications being tested; however, discomfort or stress from the sensory tests may occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had a sickle cell pain crisis treated with opioids in the last year.

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I am between 15 and 40 years old and can provide consent or have parental consent if under 18.

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I have been diagnosed with sickle cell disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and every three months while enrolled in the study, up to 48 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and every three months while enrolled in the study, up to 48 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and every three months while enrolled in the study, up to 48 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in pain pain severity

Secondary study objectives

Change in healthcare utilization for pain

Change in pain interference

Change in physical function

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Individuals living with sickle cell diseaseExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met