Trial Summary
What is the purpose of this trial?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).
Will I have to stop taking my current medications?
The trial requires that participants who are on chronic pain medications like NSAIDs, acetaminophen, or opioids must be on a stable dose for at least 4 weeks before joining. So, you won't have to stop taking them, but you need to be on a consistent dose.
What data supports the effectiveness of the treatment Quantitative Sensory Testing (QST) for sickle cell disease?
Quantitative Sensory Testing (QST) is used to understand pain and sensory processing in sickle cell disease, and it has shown that thermal testing may be sensitive to effective therapies like hydroxycarbamide, which can reduce pain sensitivity over time. This suggests QST can be a useful tool in evaluating pain management strategies for sickle cell disease.
12345Is Quantitative Sensory Testing (QST) safe for humans?
Quantitative Sensory Testing (QST) is generally considered safe and well-tolerated in humans, including those with sickle cell disease. Studies have shown that it is feasible to use and does not cause significant adverse effects.
12346How is the treatment Quantitative Sensory Testing (QST) different from other treatments for sickle cell disease?
Quantitative Sensory Testing (QST) is unique because it is a noninvasive method used to assess sensory nerve function and pain processing, rather than directly treating sickle cell disease. It helps to understand the types of pain and altered pain processing in patients, which can guide the management of chronic pain in sickle cell disease.
12347Eligibility Criteria
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).Inclusion Criteria
I have had a sickle cell pain crisis treated with opioids in the last year.
I am between 15 and 40 years old and can provide consent or have parental consent if under 18.
I have been diagnosed with sickle cell disease.
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Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Initial Assessment
Participants complete a virtual visit with survey questions followed by an in-person visit for standard testing to understand pain handling
1-2 weeks
1 virtual visit, 1 in-person visit
Longitudinal Monitoring
Participants receive brief surveys on pain experiences every three months
Up to 48 months
Electronic surveys every 3 months
Follow-up
Participants are monitored for changes in pain severity, interference, healthcare utilization, psychological distress, and physical function
4 weeks
Participant Groups
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.
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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Duke University Medical CenterDurham, NC
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Who Is Running the Clinical Trial?
Duke UniversityLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Altered pain processing and sensitization in sickle cell disease: a scoping review of quantitative sensory testing findings. [2023]Over 50% of adults living with sickle cell disease have chronic pain, but the underlying mechanisms of chronic pain in this population remain unclear. Quantitative sensory testing is an important measurement tool for understanding pain and sensory processing. This scoping review summarizes quantitative sensory testing methodologies used in sickle cell studies and the evidence for central sensitization in this population.
Quantitative sensory testing in children with sickle cell disease: additional insights and future possibilities. [2020]Quantitative sensory testing (QST) is used in a variety of pain disorders to characterize pain and predict prognosis and response to specific therapies. In this study, we aimed to confirm results in the literature documenting altered QST thresholds in sickle cell disease (SCD) and assess the test-retest reliability of results over time. Fifty-seven SCD and 60 control subjects aged 8-20 years underwent heat and cold detection and pain threshold testing using a Medoc TSAII. Participants were tested at baseline and 3 months; SCD subjects were additionally tested at 6 months. An important facet of our study was the development and use of a novel QST modelling approach, allowing us to model all data together across modalities. We have not demonstrated significant differences in thermal thresholds between subjects with SCD and controls. Thermal thresholds were consistent over a 3- to 6-month period. Subjects on whom hydroxycarbamide (HC) was initiated shortly before or after baseline testing (new HC users) exhibited progressive decreases in thermal sensitivity from baseline to 6 months, suggesting that thermal testing may be sensitive to effective therapy to prevent vasoocclusive pain. These findings inform the use of QST as an endpoint in the evaluation of preventative pain therapies.
Safety and Utility of Quantitative Sensory Testing among Adults with Sickle Cell Disease: Indicators of Neuropathic Pain? [2022]Pain is the hallmark symptom of sickle cell disease (SCD), yet the types of pain that these patients experience, and the underlying mechanisms, have not been well characterized. The study purpose was to determine the safety and utility of a mechanical and thermal quantitative sensory testing (QST) protocol and the feasibility of utilizing neuropathic pain questionnaires among adults with SCD.
Quantitative sensory testing is feasible and is well-tolerated in patients with sickle cell disease following a vaso-occlusive episode. [2022]Sickle cell disease (SCD) is an inherited blood disorder characterized by abnormally shaped sickle cells. The hallmark of this disease is intermittent, painful vaso-occlusive episodes (VOE), but a subset of individuals with SCD experience chronic pain. The mechanism of transition to chronic pain is not well understood in SCD, but there is evidence of altered pain processing in individuals with SCD. The impact of VOE on pain sensitivity is not established. The objective of this study was to determine the feasibility and tolerability of quantitative sensory testing (QST) in SCD following a VOE to better understand the contribution of VOE to the development of chronic pain.
A QST-based Pain Phenotype in Adults With Sickle Cell Disease: Sensitivity and Specificity of Quality Descriptors. [2022]We sought to refine a screening measure for discriminating a sensitized or normal sensation pain phenotype among African American adults with sickle cell disease (SCD).
Quantitative sensory testing: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. [2022]This assessment evaluates the clinical utility, efficacy, and safety of quantitative sensory testing (QST).
Quantitative assessment of cutaneous thermal and vibration sensation and thermal pain detection thresholds in healthy children and adolescents. [2022]Quantitative sensory testing (QST) is a noninvasive, computer-assisted method for assessing function in peripheral small and large sensory fibers. In order to use QST for clinical neurological assessment in children, it is necessary: (1) to determine whether children can reliably perform these tests and (2) to characterize normal ranges in healthy children. Values of cold sensation, warm sensation, cold pain, heat pain, and vibration sensation detection thresholds were determined in the hand and foot with the method of limits (MLI) and method of levels (MLE) in 101 healthy children aged 6-17 years using a commercially available device. Both MLI and MLE were well-accepted by children, and there was good reproducibility between two sessions. The MLE takes longer to perform but produces lower thermal detection thresholds than the MLI. In the MLI, vibration and warm sensation showed higher thresholds in the foot than hand, whereas cold pain showed lower thresholds in the foot than hand. Based on these results, QST may be used to document and monitor the clinical course of sensory abnormalities in children with neurological disorders or neuropathic pain.