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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. 20-035-1 (Dr. Matthew Imperioli, PI): The provision of video information effect on the level of pain perception during electrodiagnostic studies: a randomized controlled trial
This study is to assess whether video information can ease patient's anxiety and pain in EMG/Nerve conduction study that were tranditionally thought to be painful compared to written information. We simply use questionaire and survery as the only intervention
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.
IRB No. 23-052-1 (Dr. Mark Litt, PI): Mobile Application Treatment for TMD: Feasibility Trial
This is a proposal for an administrative supplement to the parent study, “Individualized Assessment and Treatment Program for TMD: Coping as a Mechanism” (U01 DE028520). The parent study is currently engaged in exploring the extent to which the training of coping skills per se is an important mechanism of psychosocial treatment. The current project seeks to lay the groundwork for expanding the range of treatment mechanisms examined to include therapeutic relationship factors (therapist support, empathy, acknowledgment). Psychosocial treatments have been effective for temporomandibular disorders (TMD), but the mechanisms of action for these treatments are unclear. Most studies of psychosocial treatment, including the parent U01, have focused on relatively specific psychosocial mechanisms, including coping skills acquisition, pain management self-efficacy, decrease in catastrophizing, increased mindfulness, acceptance, and readiness to change behavior to ameliorate pain. The 2 therapist-delivered treatments in the parent study are packaged CBT or Individualized Assessment and Treatment (IATP). Left untested in this study are common therapeutic factors that often emerge as influential in pain outcome research. These common, non-specific therapeutic factors include (especially): the therapeutic alliance; interpretation and understanding; emotional expression; reinforcement; information; and reassurance and support. Because both conditions of the parent U01 involve similar levels of therapist involvement, therapist support and other treatment-non-specific variables cannot be tested clearly. One way to assess these factors is to introduce a pain treatment that explicitly does not contain these factors; i.e., a treatment that does not employ therapists or require supervision by health care professionals. There are currently no studies published in which therapist-led treatments have been compared to a mobile application-based treatment. We therefore propose to pilot test a mobile application treatment condition (painTrainer©) added as an additional treatment condition to the parent study, and provided to 20 patients in the coming year. This condition will deliver the content of the CBT condition of the parent study, but will do so with no therapist contact. If this mobile application is found credible and acceptable it may be used in additional comparisons with treatments conducted by therapists. Thus at some point we will be able to parse the effects of cognitive-behavioral treatment content per se and therapist support factors. An additional benefit of testing such a mobile application is that it might in the future provide a means to expand the reach of pain management professionals to remote and underserved populations.
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. 23-090-2 (Dr. Hardeep Singh, PI): Effect of Depo-Medrol application on the psoas muscle after transpsoas LLIF on post-operative hip flexor weakness, thigh pain and numbness.
Goal: The goal of this study is to determine the effects of a corticosteroid adminstired to the psoas muscle following a transpsoas LLIF on postoperative hip flexor weakness and thigh pain and numbness. Specific Objectives Primary Objective and Outcome Measure: Quantify the difference in thigh pain measured on the visual analog pain scale (VAS) between those receiving a depo-medrol injection and those who did not over 3 postoperative time periods: 2-3, 6, and 12 weeks following surgery. Secondary Objectives and Outcome Measures: Quantify the difference in rates and severity of postoperative hip flexor weakness, and numbness both with and with out application of depo-medrol to the psoas between those that did and did not receive a depo-medrol injection. Quantify patient reported outcomes measures (PROMs) (EQ5D, ODI, and sciatica Bothersome index between those that did and did not receive a depo-medrol injection. Specifically: EQ5D: Eur-Quality of Life 5 dimension questionnaire ODI: Oswestry Disability Index Determine effect of depo-medrol application on fusion rates and how it differs between those that did and did not receive a depo-medrol injection. Ancillary Objectives and Outcome Measures: To determine the effect of clinically relevant covariates including sociodemographic and comorbidities on the course of postoperative pain and associated outcome measures and whether the effect of these covariates moderate the effect of postoperative pain. Groups: Control group (standard care) - 1cc gel foam powder mixed with thrombin Steroid group (standard care + study intervention) - 1cc gel foam powder mixed with thrombin and 80mg depomedrol