QST-Pupillometry in Sickle Cell Disease Patients

Completed

• Conditions: SCD With Severe Phenotype (HbSS, HbSβ0 Thalassemia, HbSOARab)
• Interventions: Other: Quantitative sensory testing

• Registration Number: NCT02242058
• Lead Sponsor: Julia Finkel

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2013-09-13
• Study First Submitted QC: 2014-09-14
• Study First Posted: 2014-09-16
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-17
• Last Update Posted: 2020-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 96

Inclusion Criteria

• SCD with severe phenotype (HbSS, HbSbeta0 thalassemia, HbSOArab)
• Relatives of SCD patients who do not have sickle cell trait or SCD; healthy controls

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pain Crisis group	Quantitative sensory testing	30 patients with sickle cell disease with severe phenotype (HbSS, HbSβ0 thalassemia, HbSOArab)
Healthy control group	Quantitative sensory testing	39 pediatric or adult relatives of sickle cell disease patients, who do not have the sickle cell trait of SCD.
Pain Service group	Quantitative sensory testing	10 patients without sickle cell disease admitted to the pain service.
High frequency pain group	Quantitative sensory testing	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)
Low Pain Frequency group	Quantitative sensory testing	39 pediatric or adult patients with low pain frequency (less than or equal to 1 severe pain episode for the last two years)

Primary Outcome Measures

Name	Time	Method
Measuring thermal responsiveness (perception and tolerance) in the outpatient groups.	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.	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).
Measuring the pupil responsiveness in outpatient groups.	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.	change over 8 consecutive days	Using the Pupillometer device, pupil responses are assessed in the inpatient groups (pain service and pain crisis).
Measure mechanical responsiveness in outpatient groups.	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).
Measuring electrical sensitivity in outpatient groups.	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.	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).
Measure mechanical responsiveness in inpatient groups.	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).

Trial Locations

Locations (2)

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

Children's National Health System; 🇺🇸 Washington, District of Columbia, United States