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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. 20-045-2: Individualized Assessment and Treatment Program for TMD: Coping as a Mechanism

The goal of this research is to determine which of the two treatments described below is more effective for helping patients manage their orofacial pain problem. Each treatment will involve 6 individual outpatient sessions with a pain therapist, each session being about one hour (except the first, which will take longer). About 160 participants will be recruited. Eligible persons will be those who have indicated they have a significant orofacial pain problem, such as pain in the area of the temporomandibular joint, that has lasted at least 3 months, and for which they wish to be treated. 160 patients with TMD-related orofacial pain of at least 3 mo duration will be assigned to 1 of 2 treatments. A highly individualized 6-session coping skills treatment based on Experience Sampling (ES) records of pain, thoughts, feelings and behaviors (Individualized Assessment and Treatment Program; IATP) will be compared to a 6-session conventional cognitive-behavioral coping skills training treatment (CBT) that does not involve close individualization of treatment. Patients in both treatments will participate in periods of experience sampling (ES) prior to and following treatment. For those in IATP, however, the ES records will help determine the patient's specific strengths, coping deficits, and situational triggers for pain to be examined in treatment. Those in CBT will receive training in a common set of skills considered important for pain control. Both treatments will be supported by Standard Care (STD: NSAIDs, soft diet, maxillary splint). Follow-ups will be administered out to 12 months post intake. Primary outcomes will be Pain, Depression symptoms, and Pain-related interference with functioning. Secondary outcomes will include physical and emotional functioning and ratings of improvement. Process or mediator variables will include within-day recordings of coping behavior and self-efficacy.

IRB No. 20-210S-1: 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.

IRB No. 23-079-1 (Dr. Scott Mallozzi, PI): Advanced Techniques in Intraoperative Monitoring for the Lateral Lumbar Interbody Fusion Procedure: A Utility Study

This study is designed to evaluate the clinical utility of a known intraoperative neuromonitoring modality (SSEP) using a nontraditional stimulation site (saphenous nerve versus more traditional posterior tibial nerve) to try to better identify nerve health changes to the lumbar plexus, which is at risk during the LLIF procedure. To quantify the clinical utility of saphenous nerve SSEP monitoring in predicting and/or mitigating new postoperative neural deficits following LLIF surgery.

IRB No. 25-160-2 (Dr. Hardeep Singh, PI): Recovery Kinetics Following Surgical Treatment for Degenerative L4-5 Spondylolisthesis: A pilot and Feasibility Study

Specific Aim(s) Evaluate recovery kinetics in patients undergoing lateral lumbar interbody fusion via prone approach + minimally invasive posterior spinal fusion (LLIF + PSF), minimally invasive transforaminal lumbar interbody fusion via tubular based retractor (MIS TLIF + PSF), and open transforaminal lumbar interbody fusion (Open TLIF + PSF) through monitoring step count during hospital stay and post operatively using a wearable fitness tracker. Compare length of stay, narcotic consumption, radiographic parameters, and fusion between groups outlined above.