Sensory Testing for Sickle Cell Disease

Overseen By Nirmish Shah, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Pregnancy, Stroke, Infection, Neuropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

70 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to understand why some people with sickle cell disease experience severe, long-lasting pain. Researchers will use quantitative sensory testing (QST) to observe how participants' bodies react to sensations like temperature and pressure. The goal is to identify patterns that could improve future pain management. People with sickle cell disease who have experienced a pain episode requiring opioid treatment in the past year might be suitable for this study. As an unphased study, this trial offers a unique opportunity to contribute to groundbreaking research that could enhance pain management for sickle cell disease patients.

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 prior data suggests that quantitative sensory testing is safe for individuals with sickle cell disease?

Research has shown that quantitative sensory testing (QST) is generally safe for people with sickle cell disease. Studies have found that QST does not trigger a pain crisis, a sudden and severe pain episode common in sickle cell patients. This testing method assesses sensitivity to various sensations, such as heat and pressure.

In past studies with adults, researchers conducted QST without causing harm. Participants experienced increased sensitivity to certain stimuli, which is normal and part of the test results. Importantly, these studies support that QST can be performed safely without increasing pain or causing other negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about quantitative sensory testing for sickle cell disease because it offers a new way to understand and manage pain in patients. Unlike traditional treatments that focus on managing symptoms with medications like opioids, this testing method helps pinpoint how patients experience different sensations, such as temperature and pressure. By uncovering individual pain profiles, it aims to tailor more effective, personalized treatment plans, potentially leading to better pain management and quality of life for those with sickle cell disease.

What evidence suggests that quantitative sensory testing is effective for predicting severe pain in sickle cell disease?

Research has shown that quantitative sensory testing (QST) aids in understanding pain across various conditions, including sickle cell disease. In this trial, participants with sickle cell disease will undergo QST to measure changes in sensitivity to sensations such as heat, cold, touch, or pressure. Studies suggest that QST can identify these changes and predict how individuals might respond to different pain treatments. Although direct proof that QST reduces pain is lacking, it enhances doctors' understanding of pain and aids in planning more effective treatments. By measuring pain sensitivity, QST may guide future pain management strategies for those with sickle cell disease. ^{6 7 8 9 10}

Who Is on the Research Team?

Martha Kenney, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Quantitative sensory testing

Trial Overview 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.

How Is the Trial Designed?

Group I: Individuals living with sickle cell disease Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Quantitative sensory testing (QST) is a reliable and well-accepted method for assessing sensory function in children aged 6-17, with good reproducibility across sessions, making it suitable for clinical use.

The study established normal sensory detection thresholds for cold, warm, cold pain, heat pain, and vibration in both hands and feet, which can help monitor sensory abnormalities in children with neurological disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative assessment of cutaneous thermal and vibration sensation and thermal pain detection thresholds in healthy children and adolescents. Meier, PM., Berde, CB., DiCanzio, J., et al.[2022]

In a study involving 57 sickle cell disease (SCD) patients and 60 control subjects aged 8-20, no significant differences in thermal pain thresholds were found between the two groups, indicating that QST may not effectively differentiate pain sensitivity in SCD compared to controls.

However, for new users of hydroxycarbamide, a treatment for SCD, there was a notable decrease in thermal sensitivity over 6 months, suggesting that QST could be a useful tool for monitoring the effectiveness of therapies aimed at preventing vaso-occlusive pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative sensory testing in children with sickle cell disease: additional insights and future possibilities. Miller, RE., Brown, DS., Keith, SW., et al.[2020]

Chronic pain affects over 50% of adults with sickle cell disease (SCD), and this scoping review analyzed 27 studies to understand the methodologies of quantitative sensory testing used to assess pain and sensory processing in this population.

The review found significant variability in testing methods across studies, with many reporting sensory abnormalities, particularly in thermal pain thresholds and temporal summation, highlighting the need for standardized protocols to better understand pain mechanisms in SCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Altered pain processing and sensitization in sickle cell disease: a scoping review of quantitative sensory testing findings. Kenney, MO., Knisely, MR., McGill, LS., et al.[2023]

Quantitative sensory testing (QST) is feasible and well-tolerated in pediatric patients with sickle cell disease (SCD) following a vaso-occlusive episode (VOE), with 62.5% of approached patients completing the test.

There were no significant differences in pain intensity after QST following a VOE compared to steady-state measurements, suggesting that VOE may not immediately alter pain sensitivity as measured by QST.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative sensory testing is feasible and is well-tolerated in patients with sickle cell disease following a vaso-occlusive episode. Bakshi, N., Lukombo, I., Belfer, I., et al.[2022]

The study developed a new scoring system called PR-Lasso, which effectively distinguishes between sensitized and normal sensation pain phenotypes in African American adults with sickle cell disease, using sensory pain quality descriptors.

The PR-Lasso score showed strong correlations with existing pain assessment tools and outperformed them, particularly the S-LANSS, indicating its potential as a more accurate measure for assessing pain in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A QST-based Pain Phenotype in Adults With Sickle Cell Disease: Sensitivity and Specificity of Quality Descriptors. Dyal, BW., Ezenwa, MO., Yoon, SL., et al.[2022]

The quantitative sensory testing (QST) protocol was found to be safe for adults with sickle cell disease (SCD) and did not trigger a pain crisis, indicating its potential utility for assessing pain mechanisms in this population.

The study revealed evidence of central and peripheral sensitization in many participants, suggesting a neuropathic component to SCD pain, with 40% of subjects showing signs of neuropathic pain based on self-report tools.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Utility of Quantitative Sensory Testing among Adults with Sickle Cell Disease: Indicators of Neuropathic Pain? Ezenwa, MO., Molokie, RE., Wang, ZJ., et al.[2022]

Quantitative sensory testing (QST) shows potential in identifying sensory abnormalities in conditions like diabetic neuropathy, but there is no strong evidence from well-powered studies to confirm its effectiveness for specific disorders.

Due to variability between different QST systems and the lack of consensus on reproducibility, results from one system cannot be directly compared to another, highlighting the need for standardized methodologies in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative sensory testing: report of the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology. Shy, ME., Frohman, EM., So, YT., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6563447/

Quantitative sensory testing in children with sickle cell disease Our study provides preliminary data to support the future examination of QST as a potentially valuable outcome measure for use in early phase clinical ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30924134/

Quantitative sensory testing in children with sickle cell disease Quantitative sensory testing (QST) is used in a variety of pain disorders to characterize pain and predict prognosis and response to specific therapies.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0006497119840570

Quantitative Sensory Testing in Children with Sickle Cell ... Significance was set at 0.05. Results: There were no significant differences in mean thermal or PPTs between SCD and control participants at ...

4. academic.oup.com academic.oup.com/painmedicine/article-abstract/25/2/144/7303870

a scoping review of quantitative sensory testing findings | Pain ... This scoping review summarizes quantitative sensory testing methodologies used in sickle cell studies and the evidence for central sensitization in this ...

5. ashpublications.org ashpublications.org/bloodadvances/article/3/23/3982/429244/End-points-for-sickle-cell-disease-clinical-trials

End points for sickle cell disease clinical trials Safety and utility of quantitative sensory testing among adults with sickle cell disease: indicators of neuropathic pain? Pain Pract . 2016.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4499503/

Safety and Utility of Quantitative Sensory Testing among ... We found that the QST protocol was safe and did not stimulate a SCD pain crisis. There was evidence of central sensitization (n=15), peripheral sensitization (n ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25581383/

Safety and Utility of Quantitative Sensory Testing ... - PubMed The QST protocol can be safely conducted in adults with SCD and provides evidence of central or peripheral sensitization, which is consistent with a ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/papr.12279

Safety and Utility of Quantitative Sensory Testing among ... We found that the QST protocol was safe and did not stimulate a SCD pain crisis. There was evidence of central sensitization (n = 15), ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S1526590019308521

Sensitivities to Thermal and Mechanical Stimuli: Adults ... Additionally, using thermal and mechanical quantitative sensory testing (QST), we found that 24/25 adults with SCD had allodynia or hyperalgesia to cold, heat ...

10. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/bjh.15876

Quantitative sensory testing in children with sickle cell ... Our study provides preliminary data to support the future examination of QST as a potentially valuable outcome measure for use in early ...