SCD With Severe Phenotype (HbSS, HbSβ0 Thalassemia, HbSOARab)QSTNCT02242058
QST-Pupillometry in Sickle Cell Disease Patients
An observational study of SCD With Severe Phenotype (HbSS, HbSβ0 Thalassemia, HbSOARab), run by Julia Finkel at 2 sites in United States.
Trial summary
There has been little progress for effective treatment of pain in sickle cell disease (SCD) patients. Many organizations have recognized that understanding the causes and reducing the burden of pain in SCD is critical in order to improve the quality of life in SCD patients. Read more about this study
- Who is it for?
- Ages 13 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- SCD With Severe Phenotype (HbSS, HbSβ0 Thalassemia, HbSOARab)
- What is being tested?
- Quantitative sensory testing
- How many people
- 96 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2013to Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 13 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: SCD patients referred to the Pain Medicine clinic, either outpatient or inpatient.
Who may be able to join
- SCD with severe phenotype (HbSS, HbSbeta0 thalassemia, HbSOArab)
- Relatives of SCD patients who do not have sickle cell trait or SCD; healthy controls
Who cannot join
- Completed overt clinical stroke or transient ischemic attack;
- Known severe vasculopathy or Moyamoya disease on brain MRA (Magnetic Resonance Angiography).
- history of having consumed alcohol within the last 12 hours prior to testing.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's National Health System
Washington D.C., District of Columbia, 20010
Children's National Medical Center
Washington D.C., District of Columbia, 20010
About this study
Official title: Quantitative Sensory Testing and Pupillometry in Sickle Cell Disease Patients.
There has been little progress for effective treatment of pain in sickle cell disease (SCD) patients. Many organizations have recognized that understanding the causes and reducing the burden of pain in SCD is critical in order to improve the quality of life in SCD patients. As patients with SCD face the challenge of living with both acute and chronic pain which is often improperly treated, our translational and interdisciplinary project aims to identify objective measures of pain sensitivity and its biochemical and genetic correlates. We hypothesize that SCD patients will have decreased tolerance to thermal and electrical stimuli.
- Being tested
- Quantitative sensory testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative sensory testingOther
| Study group | Role | What they receive |
|---|---|---|
| High frequency pain group | 39 pediatric or adult patients with high pain frequency (greater than or equal to 3 ER visits and/or hospitalizations for pain per year over the last two years) Receives: Other: Quantitative sensory testing | |
| Low Pain Frequency group | 39 pediatric or adult patients with low pain frequency (less than or equal to 1 severe pain episode for the last two years) Receives: Other: Quantitative sensory testing | |
| Healthy control group | 39 pediatric or adult relatives of sickle cell disease patients, who do not have the sickle cell trait of SCD. Receives: Other: Quantitative sensory testing | |
| Pain Crisis group | 30 patients with sickle cell disease with severe phenotype (HbSS, HbSβ0 thalassemia, HbSOArab) Receives: Other: Quantitative sensory testing | |
| Pain Service group | 10 patients without sickle cell disease admitted to the pain service. Receives: Other: Quantitative sensory testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring thermal responsiveness (perception and tolerance) in the outpatient groups.
Using a TSA (thermal sensory analyzer), the patients hot and cold perception and tolerance will be measured in the outpatient groups (high-pain and low-pain frequency and controls).
Measured: change between baseline and at 90day follow-up
Measuring thermal responsiveness (perception and tolerance) in the inpatient groups.
Using a TSA thermal sensory analyzer, the patients hot and cold perception and tolerance will be measured in the inpatient groups (pain crisis and pain service).
Measured: change over 8 consecutive days
Measure mechanical responsiveness in outpatient groups.
Using the Wagner PPIX 50 Pressure device, patient's tolerance to pressure is assessed in the outpatient groups (high-pain and low-pain frequency and controls).
Measured: change between baseline and 90 day follow-up
Measure mechanical responsiveness in inpatient groups.
Using the Wagner PPIX 50 Pressure device, patient's tolerance to pressure is assessed in the inpatient groups (pain crisis and pain service).
Measured: change over 8 consecutive days
Measuring the pupil responsiveness in outpatient groups.
Using the Pupillometer device, pupil responses are assessed in the outpatient groups (high-pain and low-pain frequency and controls).
Measured: change between baseline and 90 day follow-up
Measuring the pupil responsiveness in inpatient groups.
Using the Pupillometer device, pupil responses are assessed in the inpatient groups (pain service and pain crisis).
Measured: change over 8 consecutive days
Measuring electrical sensitivity in outpatient groups.
Using the Neurometer device, to assess electrical sensory perception and tolerance in the outpatient groups (high-pain and low-pain frequency and control).
Measured: change between baseline and at 90day follow-up
Measuring electrical sensitivity in inpatient groups.
Using the Neurometer device, to assess electrical sensory perception and tolerance in the outpatient groups (pain service and pain crisis).
Measured: change over 8 consecutive days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2014 (estimated)
- Study startAug 2013
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCD With Severe Phenotype (HbSS, HbSβ0 Thalassemia, HbSOARab)Studies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Julia Finkel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Julia Finkel, Children's National Research Institute
- Investigators
- Julia Finkel, MD, Principal investigator, Children's National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02242058
- Sponsor's protocol ID
- QST-Pupillo3614
- Acronym
- QST
- Status last verified
- Jan 2020
- First submitted
- 13 Sep 2013
- Last updated
- 21 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Sensory Testing and Pupillometry in Sickle Cell Disease Patients.
- ClinicalTrials.gov ID
- NCT02242058
- Acronym / sponsor ID
- QST / QST-Pupillo3614
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Julia FinkelUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 16 Sep 2014 (estimated)
- 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.
There has been little progress for effective treatment of pain in sickle cell disease (SCD) patients. Many organizations have recognized that understanding the causes and reducing the burden of pain in SCD is critical in order to improve the quality of life in SCD patients. As patients with SCD face the challenge of living with both acute and chronic pain which is often improperly treated, our translational and interdisciplinary project aims to identify objective measures of pain sensitivity and its biochemical and genetic correlates. We hypothesize that SCD patients will have decreased tolerance to thermal and electrical stimuli.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| High frequency pain group | – | Other: Quantitative sensory testing39 pediatric or adult patients with high pain frequency (greater than or equal to 3 ER visits and/or hospitalizations for pain per year over the last two years) |
| Low Pain Frequency group | – | Other: Quantitative sensory testing39 pediatric or adult patients with low pain frequency (less than or equal to 1 severe pain episode for the last two years) |
| Healthy control group | – | Other: Quantitative sensory testing39 pediatric or adult relatives of sickle cell disease patients, who do not have the sickle cell trait of SCD. |
| Pain Crisis group | – | Other: Quantitative sensory testing30 patients with sickle cell disease with severe phenotype (HbSS, HbSβ0 thalassemia, HbSOArab) |
| Pain Service group | – | Other: Quantitative sensory testing10 patients without sickle cell disease admitted to the pain service. |
Who may qualify
- Ages
- 13 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- SCD patients referred to the Pain Medicine clinic, either outpatient or inpatient.
Key inclusion criteria (2 listed)
- SCD with severe phenotype (HbSS, HbSbeta0 thalassemia, HbSOArab)
- Relatives of SCD patients who do not have sickle cell trait or SCD; healthy controls
Key exclusion criteria (3 listed)
- Completed overt clinical stroke or transient ischemic attack;
- Known severe vasculopathy or Moyamoya disease on brain MRA (Magnetic Resonance Angiography).
- history of having consumed alcohol within the last 12 hours prior to testing.
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 testing | Other | Healthy control group, High frequency pain group, Low Pain Frequency group, Pain Crisis group, Pain Service group |
Primary outcome
Measuring thermal responsiveness (perception and tolerance) in the outpatient groups.
Time frame: change between baseline and at 90day follow-up
Using a TSA (thermal sensory analyzer), the patients hot and cold perception and tolerance will be measured in the outpatient groups (high-pain and low-pain frequency and controls).
Measuring thermal responsiveness (perception and tolerance) in the inpatient groups.
Time frame: change over 8 consecutive days
Using a TSA thermal sensory analyzer, the patients hot and cold perception and tolerance will be measured in the inpatient groups (pain crisis and pain service).
Measure mechanical responsiveness in outpatient groups.
Time frame: change between baseline and 90 day follow-up
Using the Wagner PPIX 50 Pressure device, patient's tolerance to pressure is assessed in the outpatient groups (high-pain and low-pain frequency and controls).
Measure mechanical responsiveness in inpatient groups.
Time frame: change over 8 consecutive days
Using the Wagner PPIX 50 Pressure device, patient's tolerance to pressure is assessed in the inpatient groups (pain crisis and pain service).
Measuring the pupil responsiveness in outpatient groups.
Time frame: change between baseline and 90 day follow-up
Using the Pupillometer device, pupil responses are assessed in the outpatient groups (high-pain and low-pain frequency and controls).
Measuring the pupil responsiveness in inpatient groups.
Time frame: change over 8 consecutive days
Using the Pupillometer device, pupil responses are assessed in the inpatient groups (pain service and pain crisis).
Measuring electrical sensitivity in outpatient groups.
Time frame: change between baseline and at 90day follow-up
Using the Neurometer device, to assess electrical sensory perception and tolerance in the outpatient groups (high-pain and low-pain frequency and control).
Measuring electrical sensitivity in inpatient groups.
Time frame: change over 8 consecutive days
Using the Neurometer device, to assess electrical sensory perception and tolerance in the outpatient groups (pain service and pain crisis).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2020.
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. This study is not recruiting at the moment.
Julia Finkel, MD principal investigator
Children's National Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SCD With Severe Phenotype (HbSS, HbSβ0 Thalassemia, HbSOARab), run by Julia Finkel at 2 sites 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 21 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring thermal responsiveness (perception and tolerance) in the outpatient groups. (time frame: change between baseline and at 90day follow-up). The study lists 8 primary outcomes in all. 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 21 Jan 2020.