Sickle Cell DiseaseNCT06139510
Predictors of Pain in Sickle Cell Disease
A study testing Quantitative sensory testing in people with Sickle Cell Disease and Chronic Pain, run by Duke University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 to 40 years
- Conditions the study is for
- Sickle Cell Disease, Chronic Pain
- What is being tested?
- Quantitative sensory testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2024to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of sickle cell disease (documentation of SS, SC, S beta + thalassemia, S beta + thalassemia) is required
- 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
- Participants who are on chronic analgesics (NSAID, acetaminophen) or opioids should be on a stable dose for 4 weeks prior to recruitment.
Who cannot join
- Age less than 15 or greater than 40 years
- Participants lacking the cognitive or mental capacity to assent to and complete study procedures
- Pregnant females
- Participants with history of a stroke with ongoing physical impairment that prevents participation in study procedures.
- 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.
- Current or active infection
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Predictors of Pain Severity and Pain-Related Outcomes in Individuals With Sickle Cell Disease
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).
Read the detailed description
Severe, disabling pain is the hallmark of sickle cell disease (SCD). SCD pain is associated with poor quality of life, early mortality, and high healthcare costs. Clinicians face great challenges in managing SCD pain because of the poor understanding of the etiology of chronic/persistent SCD pain and the absence of validated clinical predictive tools that can accurately identify individuals with SCD who are at risk of developing severe, persistent pain with associated physical and/or psychological disability. The overall objective of this study is to identify predictors of pain severity and pain-related outcomes in SCD using a prospective, longitudinal study design. This proposal is supported by the hypothesis that pain-specific psychological and sensory factors are strong, modifiable predictors of SCD pain severity and pain-related outcomes. The understanding of pain-specific psychological and sensory predictors of SCD pain outcomes is anticipated to have important implications for (1) identifying SCD patients who are at risk for severe pain outcomes, (2) informing preventive and therapeutic management of SCD pain, and (3) selecting patients for clinical trials of non-opioid interventions for SCD pain. The hypothesis will be tested by pursuing two specific aims: Aim 1) Determine psychological predictors of pain outcomes; and Aim 2) Ascertain the strength of pain distribution and sensitivity as predictors of pain outcomes. 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).
- Conditions
- Sickle Cell Disease, Chronic Pain
- Being tested
- Quantitative sensory testing
- Keywords
- quantitative sensory testing, pain sensitization
- Medical subject headings
- Anemia, Sickle Cell, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative sensory testingOther
All participants enrolled in the study 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. QST is not an intervention, it is a method that is used to assess and understanding pain processing in an individual.
| Study group | Role | What they receive |
|---|---|---|
| Individuals living with sickle cell disease | Other | 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. Receives: Other: Quantitative sensory testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain pain severity
Will be determined by answering the severity subscale of the Brief Pain Inventory
Measured: At baseline and every three months while enrolled in the study, up to 48 months
Secondary outcomes (4)
Change in psychological distress
Will be determined based on answers to the anxiety and depression subscales of the PROMIS-29 questionnaire. A composite score of the subscales will be reported.
Measured: At baseline and every three months while enrolled in the study, up to 48 months
Change in pain interference
Will be determined based on answers to the pain interference subscale of the PROMIS-29 questionnaire.
Measured: At baseline and every three months while enrolled in the study, up to 48 months
Change in physical function
Will be determined based on answers to the physical function subscale of the PROMIS-29 questionnaire.
Measured: At baseline and every three months while enrolled in the study, up to 48 months
Change in healthcare utilization for pain
Will be determined based on answers to the PhenX Frequency of Sickle Cell Pain Episodes Per year questionnaire.
Measured: At baseline and every three months while enrolled in the study, up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start12 Jul 2024
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Martha Kenney, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06139510
- Sponsor's protocol ID
- Pro00112024
- Other IDs
- 1K01HL169339-01
- Status last verified
- Oct 2025
- First submitted
- 15 Nov 2023
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Pain Severity and Pain-Related Outcomes in Individuals With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT06139510
- Acronym / sponsor ID
- Pro00112024
- Conditions
- Sickle Cell Disease, Chronic Pain
- Keywords
- quantitative sensory testing, pain sensitization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 12 Jul 2024 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 18 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Severe, disabling pain is the hallmark of sickle cell disease (SCD). SCD pain is associated with poor quality of life, early mortality, and high healthcare costs. Clinicians face great challenges in managing SCD pain because of the poor understanding of the etiology of chronic/persistent SCD pain and the absence of validated clinical predictive tools that can accurately identify individuals with SCD who are at risk of developing severe, persistent pain with associated physical and/or psychological disability. The overall objective of this study is to identify predictors of pain severity and pain-related outcomes in SCD using a prospective, longitudinal study design. This proposal is supported by the hypothesis that pain-specific psychological and sensory factors are strong, modifiable predictors of SCD pain severity and pain-related outcomes. The understanding of pain-specific psychological and sensory predictors of SCD pain outcomes is anticipated to have important implications for (1) identifying SCD patients who are at risk for severe pain outcomes, (2) informing preventive and therapeutic management of SCD pain, and (3) selecting patients for clinical trials of non-opioid interventions for SCD pain. The hypothesis will be tested by pursuing two specific aims: Aim 1) Determine psychological predictors of pain outcomes; and Aim 2) Ascertain the strength of pain distribution and sensitivity as predictors of pain outcomes. 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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals living with sickle cell disease | Other | Other: Quantitative sensory testingParticipants 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 may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of sickle cell disease (documentation of SS, SC, S beta + thalassemia, S beta + thalassemia) is required
- 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
- Participants who are on chronic analgesics (NSAID, acetaminophen) or opioids should be on a stable dose for 4 weeks prior to recruitment.
Key exclusion criteria (7 listed)
- Age less than 15 or greater than 40 years
- Participants lacking the cognitive or mental capacity to assent to and complete study procedures
- Pregnant females
- Participants with history of a stroke with ongoing physical impairment that prevents participation in study procedures.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quantitative sensory testingAll participants enrolled in the study 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. QST is not an intervention, it is a method that is used to assess and understanding pain processing in an individual. | Other | Individuals living with sickle cell disease |
Primary outcome
Change in pain pain severity
Time frame: At baseline and every three months while enrolled in the study, up to 48 months
Will be determined by answering the severity subscale of the Brief Pain Inventory
4 secondary outcomes
Change in psychological distress
Time frame: At baseline and every three months while enrolled in the study, up to 48 months
Change in pain interference
Time frame: At baseline and every three months while enrolled in the study, up to 48 months
Change in physical function
Time frame: At baseline and every three months while enrolled in the study, up to 48 months
Change in healthcare utilization for pain
Time frame: At baseline and every three months while enrolled in the study, up to 48 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Martha Kenney, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative sensory testing in people with Sickle Cell Disease and Chronic Pain, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martha Kenney, MD (9196814877, martha.kenney@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain pain severity (time frame: At baseline and every three months while enrolled in the study, up to 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.