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Clinical Trials: Pain
IRB No. 17-193C-6.2 (Dr. Biree Andemariam, PI): Measures of Functional Ability in Adults with Sickle Cell Disease
This study is a prospective, clinical/translational research pilot study using a web-based, daily survey. Pain in adults with sickle cell disease (SCD) is unique in that patients often experience acute and chronic pain simultaneously. Numerical rating scales are often unhelpful in the measurement of this type of pain as patients tend to report high pain scores despite noted variations in functional ability. This pattern of functional improvement with continued report of high pain intensity scores is common in patients with recurrent and chronic pain. A functional assessment tool that can reflect functional changes over brief time periods (days) is necessary to 1) allow for the examination of the impact of acute pain on usual function, 2) investigate the extent to which acute pain symptoms create a burden for patients and caretakers, 3) use as an outcome measure that would allow for objective measurement of changes in functioning as the result of acute pain interventions, and 4) study individual differences in functioning within specific patient groups. We have previously developed the YAPFAQ, a measure of acute functional ability in youth with sickle cell disease. No tool for measurement of daily functional ability in adults with SCD exists. The aim of this project is to provide preliminary data on item content for an adult acute functional ability tool, while examining the impact of other variables such as pain, mood and sleep on daily function in individuals with SCD. We propose to complete a pilot study of 40 adults between the ages of 21-40 years with SCD. Each adult will access an online survey daily for 30 days to report 20-30 items regarding their functional ability, sleep, mood and pain. Participants will access the daily survey through any standard web-browser using REDCap and complete the survey between 6pm-10pm each day.
IRB No. 18-036S-6.2 (Dr. Biree Andemariam, PI): Development of Novel Tools to Treat Vaso-Occlusive Pain in Sickle Cell Disease
This study is a prospective, clinical/translational research study with both long term and immediate goals. The long-term goals of this project are two-fold: (i) to quantitatively understand how the adhesive cellular interaction between blood cells and the endothelium can be modified to prevent VOE; (ii) To create simple point-of-care diagnostic tests that will indicate the risk of VOE onset. Our central hypothesis is that the onset of VOE is temporally-related to an increase in blood adhesion and viscosity that can be reversed with anti-adhesion therapy. The immediate goals of this project are to (1) measure the relationship between steady-state SS-RBC--endothelium adhesion and VOE frequency, and identify changes in SS-RBC--endothelium adhesion during VOE onset, (2) demonstrate an ex vivo effect of anti-adhesive therapy on SS-RBC--endothelium adhesion that directly or indirectly targets the cAMP-PKA pathway, and (3) develop simple a single-use microfluidics device capable of indicating the risk for VOE. Atomic force microscope (AFM) and microfluidics will be used to measure adhesion of endothelial proteins to human SS-RBCs isolated from SCD patients at steady-state (no VOE) and at VOE onset. AFM allows specific quantification at the single molecule level of both the number and strength of protein-protein binding events on the RBC surface. Microfluidics allow for high throughput screening. To achieve our goals, we will complete the following specific aims: Aim 1: Determine the relationship between (1) steady-state SS-RBC adhesion and frequency of VOEs and (2) changes in SS-RBC adhesion level and onset of VOEs. Aim 2: Measure the ex vivo effect of pharmacologic blockade of receptor--ligand adhesion in the B-adrenergic system. Aim 3: Design, fabricate, and validate a simple, inexpensive, single-use microfluidics device coupled with a smart-phone kit and software application that will indicate the risk for VOE onset. Our expected outcomes and accomplishments are to (1) identify a relationship between enhanced SS-RBC adhesion and VOE onset, (2) identify therapies capable of limiting the onset and duration of VOEs and (3) create a single-use microfluidics device capable of indicating the risk of VOE onset. This has the potential to impact the development of needed treatments to prevent and reverse VOEs in millions of individuals with SCD worldwide. We will enroll 5 eligible subjects with SCD and 5 healthy controls over a three-year period. During this time, each SCD subject will donate 5 baseline blood samples to ensure we establish a true baseline. Baseline blood samples will be collected periodically during routine clinic visits over the three year study enrollment; at this time, subjects will donate 12 cc of blood. SCD subjects will also document when a painful vaso-occlusive episode (VOE) occurs and will donate a total of 3-4 VOE blood samples over the three year study period. During each VOE blood draw, SCD subjects will donate 12cc of blood. The initial VOE blood sample must be obtained within 48 hours of the VOE onset. Subsequent samples can be obtained in the days following VOE onset or at the time of a new VOE episode. Healthy controls will donate 12 cc of blood on three occasions, with each blood draw being at least one month apart. Blood will be analyzed for CBC/differential, hemoglobin electrophoresis, epinephrine levels, RBC adhesion, and blood viscosity. With this approach, we will test the hypothesis that there is a relationship between steady-state SS-RBC adhesion and frequency of VOEs (Specific Aim #1). SS-RBC adhesion at VOE onset will be compared to steady-state in order to test the hypothesis that enhanced SS-RBC adhesion mediates VOE (Specific Aim #1). Utilizing blood collected from subjects with SCD during steady-state and within 48 hours of VOE onset, we will measure the adhesion of SS-RBCs to the endothelial ligands.
IRB No. 20-210S-1 (Dr. Nathaniel Rickles, PI): The Feasibility and Effectiveness of an Opioid Package Prototype (OPP) to Impact Opioid Prescribing, Dispensing, and Patient Use Outcomes
This study is looking at how the packaging of opioid medication affects the use of opioids following surgery. The study is comparing opioid use when provided in a standard amber vial (normal orange bottle) versus a blister pack called the Opioid Package Prototype, or “OPP” for short. Study participants will receive their post-surgery opioid medication from Arrow Pharmacy (located in the Outpatient Pavillion) in one of the two packages, which are pre-assigned. Participants will also complete surveys and/or interviews before surgery and at 1 week, 1 month and 3 months after surgery. Basic criteria to participate include being an adult having one of 17 common surgical procedures by a participating orthopaedic surgeon and using opioid medication for post-operative pain.