Funded by the National Institutes of Health (R01AG085287), Co-PIs: Bruehl/Billings, Vanderbilt University Medical Center
Approximately 1 million total knee arthroplasty (TKA) procedures are carried out in the U.S. annually to address underlying knee joint pain and functional limitations from osteoarthritis. Although the procedure is effective for many patients, 15% or more report unsatisfactory long-term pain despite a successful surgery. Post-TKA pain at up to 4-year follow-up has been reported to be worse than the preoperative pain in 7% of TKA patients. Our prior project (R01AG048915) found evidence that oxidative stress (OS) may be a contributing factor to post-TKA chronic pain maintenance. The key objective of this project is to test for the first time via a randomized controlled trial whether a potent antioxidant intervention (Glycine plus N-acetylcysteine [GlyNAC]) improves long-term postsurgical pain and physical function outcomes and reduces opioid analgesic use in patients undergoing TKA.
Title: Integrative Health Coaching for Back Pain: An Emergency Department-to-Home Recovery Model
Funded by the Department of Defense, PI: Coronado, Vanderbilt University Medical Center
Nonpharmacological pain management strategies centered on a biopsychosocial model are urgently needed within the emergency department (ED) setting. Low back pain is a frequent complaint prompting patients to seek ED care. Despite the availability of effective behavioral strategies for low back pain, the primary ED treatment is medication, and specifically opioids. To help minimize the potential for long-term opioid addiction and reliance on ED care, we propose an innovative biopsychosocial model of care involving health coaching, that is focused on self-management for ED patients with chronic low back pain. Our aim is to test the feasibility and acceptability of a remote integrative health coaching intervention after ED discharge. We will capture and report on outcomes related to pain, opioid use, and return ED visits up to 6 months after discharge.
Funded by the National Institute of Health (R01 MD016838) PI: Morris, Vanderbilt University Medical Center
Non-Hispanic Black adults are disproportionately impacted by both acute and chronic post-injury pain relative to Non-Hispanic Whites, yet the biopsychosocial mechanisms underlying these racial differences remain poorly characterized. This prospective study will identify similarities and differences in the extent to which biobehavioral and social factors explain the transition to chronic pain in Non-Hispanic Black and White patients with traumatic orthopedic injuries. Enhanced scientific understanding of these mechanisms may provide a unique opportunity to begin mitigating these clinical pain disparities.
Title: Mechanistic-Based Treatment of Intersitital Cystitis/Bladder Pain Syndrome
Funded by the National Institute of Diabetes and Digestive and Kidney Disease (1R01DK133415-01A1) PI: McKernan, Vanderbilt University Medical Center
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition lacking effective treatments that affects 4-12 million people in the United States. The pain involved in IC/BPS can be debilitating and incurable. Symptoms involve pelvic pain, pressure, and discomfort coupled with urinary urgency and frequency. The way individuals with IC/BPS experience symptoms varies widely, and new research shows certain IC/BPS sub-groups differ in their pain and symptom presentations based on the mechanism causing their illness. To help improve treatment for IC/BPS, this project seeks to understand how IC/BPS sub-groups may respond differently to two separate therapies (pelvic floor physical therapy and cognitive-behavioral therapy specific to IC/BPS). This study will evaluate who may benefit from each treatment and whether neurobiological mechanisms may moderate outcomes and change with treatment. The overarching goal of this project is to improve future IC/BPS precision-medicine care efforts.
Funded by the National Center for Complementary and Integrative Health (R01AT009680-04), PI: Bruehl, Vanderbilt University Medical Center; Burns, Rush University
Non-drug interventions for management of chronic back pain are being increasingly used by patients. While there is evidence that such interventions can help patients manage their pain more effectively, there is little evidence regarding how these interventions exert their beneficial effects. This project focuses on two common complimentary medicine interventions: mindfulness therapy and spinal manipulation therapy. Patients with chronic back pain will be randomized to receive one of these two interventions for 8 weeks, and will participate in laboratory assessment sessions to evaluate pain sensitivity and natural pain inhibition mechanisms before starting the intervention, after the 4th intervention session, and again after completion of the 8th intervention session. The aim of this study is to determine the extent to which beneficial effects of the two interventions are due to theory-specific mechanisms (mindfulness changes for mindfulness therapy, spinal flexibility for spinal manipulation therapy) versus non-specific mechanisms such as changes in the body's natural ability to inhibit pain or psychological changes.
Title: Optimizing Psychosocial Treatment of Interstitial Cystitis/Bladder Pain Syndrome
Funded by the National Institute of Diabetes and Digestive and Kidney Disease (K23DK118118) PI: McKernan, Vanderbilt University Medical Center
Interstitial cystitis/bladder pain syndrome (IC/BPS) is a severe pain condition affecting 3-8 million people in the United States lacking treatments that work. Emotional suffering is common in IC/BPS and known to make physical symptoms worse, and studies show patient sub-groups respond differently to treatment. By creating and testing a psychosocial intervention specific to IC/BPS, we will learn if this intervention improves patient wellness, who the intervention works best for, and how the body’s pain processing influences outcomes. (https://clinicaltrials.gov/ct2/show/NCT04275297)
Title: Fibromyalgia TENS in Physical Therapy Study (TIPS): an embedded pragmatic clinical trial
Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (UH3AR076387), PI: Crofford, Vanderbilt University Medical Center; Sluka, University of Iowa
Fibromyalgia is a chronic pain condition characterized by widespread musculoskeletal pain, tenderness, and stiffness associated with fatigue and sleep disturbance. TENS has been shown to be effective for this patient population; however, TENS is underused by physical therapists in clinical practice. This pragmatic trial is being conducted to compare effectiveness of physical therapy with or without the addition of TENS for patients with fibromyalgia. (https://clinicaltrials.gov/ct2/show/NCT04683042)
Title: Psychosocial and Oxidative Stress Mechanisms of Post-surgical Chronic Pain
Funded by the National Institutes of Health (R01AG048915), PI: Bruehl, Vanderbilt University Medical Center
Total knee arthroplasty (TKA) is an increasingly common surgical procedure in older adults. Although effective for many patients, 15% or more experience unsatisfactory pain outcomes. While limited to post-surgical chronic pain in some patients, others also develop reginal allodynia and hyperalgesia, edema, and autonomic features indicating Complex Regional Pain Syndrome (CRPS), a particularly difficult to treat chronic pain condition. The mechanisms of post-TKA chronic pain and CRPS are not well understood. The most common TKA procedure involves application of a tourniquet to the operated limb for extended periods (up to ≈ 2 hours). Animal models indicate that extended tourniquet application followed by reperfusion when the tourniquet is removed leads to ischemic reperfusion injury, which via increased oxidative stress can result in prolonged neuropathic pain and clinical features of CRPS. One key objective of this project is to examine for the first time in humans the impact of baseline and perioperative oxidative stress, as indexed by F2 - isoprostanes, on long-term pain, CRPS, and functional outcomes following TKA. One known predictor of post-TKA chronic pain is greater preoperative negative affect (specifically, depression and anxiety). Emerging literature suggests that elevated depression and anxiety may be associated with elevated oxidative stress levels.
