Pain Clinical Trial
Official title:
Exploratory Studies of Psychophysical Pain Phenotyping and Genetic Variability in Sickle Cell Disease
Verified date | December 2020 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Background: - Pain is the most common symptom of sickle cell disease. Episodes of severe sickle cell pain are known as "crises." High rates of pain crises are associated with a higher risk of early death. Some people with sickle cell disease have many severe pain crises while others experience fewer crises. This difference in pain crisis may be caused by sensitivity to pain. People with high sensitivity to pain may have more pain crises. Many factors, including a person's genetic makeup, determine sensitivity to pain. Comparing genetic information from people with sickle cell disease and healthy volunteers may provide more information on pain and sickle cell disease. Objectives: - To study genetics and pain sensitivity in sickle cell disease. Eligibility: - African or African American individuals at least 18 years of age with sickle cell disease. - Healthy African or African American volunteers at least 18 years of age. Design: - Participants will be screened with a medical history and physical exam. They will also provide blood and urine samples. - Participants will have the following tests: - Quantitative sensory testing to measure sensitivity to pressure, heat, cold, and mechanical pain. - EndoPat test to measure blood vessel function and reaction. - Questionnaires about mood, evidence of depression, pain, quality of sleep, and sleep disturbances. - Measures of daily pain, whether or not related to sickle cell disease. - After the first visit, those in the study will have monthly study visits for 6 months. The above tests will be repeated at these visits.
Status | Completed |
Enrollment | 67 |
Est. completion date | December 9, 2020 |
Est. primary completion date | May 31, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | - ELIGIBILITY CRITERIA FOR ALL PARTICIPANTS: All study participants must be of self-described African or African American ancestry. They will be at least 18 years old and must be able to provide informed, written consent for participation. INCLUSION CRITERIA: Inclusion Criteria for Sickle Cell Patients 1. Diagnosis of sickle cell disease (documentation of SS, SC, S beta + thalassemia, S beta + thalassemia by electrophoresis is required). 2. If taking chronic analgesics (NSAID, acetaminophen) or opioids, study subjects should be on a stable dose for 4 weeks prior to recruitment. Inclusion Criteria for Control Subjects 1. Hemoglobin AA genotype by HPLC or hemoglobin electrophoresis. 2. General good health defined as the absence of untreated major medical conditions (e.g. uncontrolled systemic hypertension, etc.). EXCLUSION CRITERIA: Exclusion Criteria for Sickle Cell Patients 1. History of severe vaso-occlusive pain crisis resulting in either evaluation in an emergency department or admission to a hospital during the two weeks prior to study enrollment. 2. Acute pain at the time of enrollment defined as spontaneous recent onset pain with a self rated score of 6 or higher on a scale of 0-10. (This is acute pain not the pain that subjects function at on a daily basis.) Exclusion Criteria for Control Subjects 1. Acute pain or injury at enrollment or a recent history of chronic pain (daily pain reported for at least 6 months) in the past 3 years. 2. Major medical/psychiatric illness known to cause pain. 3. Sickle cell trait. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Heart, Lung, and Blood Institute (NHLBI) |
United States,
Ataga KI, Moore CG, Jones S, Olajide O, Strayhorn D, Hinderliter A, Orringer EP. Pulmonary hypertension in patients with sickle cell disease: a longitudinal study. Br J Haematol. 2006 Jul;134(1):109-15. — View Citation
Bookman EB, Langehorne AA, Eckfeldt JH, Glass KC, Jarvik GP, Klag M, Koski G, Motulsky A, Wilfond B, Manolio TA, Fabsitz RR, Luepker RV; NHLBI Working Group. Reporting genetic results in research studies: summary and recommendations of an NHLBI working group. Am J Med Genet A. 2006 May 15;140(10):1033-40. — View Citation
Campbell CM, Kronfli T, Buenaver LF, Smith MT, Berna C, Haythornthwaite JA, Edwards RR. Situational versus dispositional measurement of catastrophizing: associations with pain responses in multiple samples. J Pain. 2010 May;11(5):443-453.e2. doi: 10.1016/j.jpain.2009.08.009. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine if thresholds for pain perception are lower in SCD than in non-SCD controls. | lower pain threshold in SCD than in non-SCD controls | Ongoing | |
Secondary | To determine if SCD subjects with higher GCH1 activity have 1) lower pain perception thresholds, 2) a higher prevalence of pain/VOC, 3) altered vascular reactivity and 4) more frequent pain co-morbidities) compared to subjects who lack this. | Ongoing | ||
Secondary | To determine if variants in the GCH1 gene alter thresholds for pain perception in sickle cell disease. | Ongoing |
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