Research

1. ACTIVE STUDIES:

• Cryoneurolysis UCSD 170973 (PI: Fisher)
• Study name: “Cryoanalgesia to Treat Post-Amputation Phantom Limb Pain: A Multicenter, Randomized, Double-Masked, Placebo-Controlled, Definitive Human Subjects Clinical Trial”
• Being conducted at NMCSD in collaboration with UCSD, funded by DoD
• The purpose of the study is to determine if temporarily freezing the nerves that go to your amputated limb—called cryoneurolysis—will decrease phantom limb pain
• Synopsis: Treatment for phantom limb pain via cryonuerolysis – freezing the nerve to provide a prolonged nerve block lasting a few months. Randomized application of either cryoneurolysis or a “sham block.” Probe is inserted and either nitrous oxide is applied or NO is vented from probe prior to application. Applied to both the sciatic and femoral nerve and patients will get same condition on each nerve, not mixed. Patients may return after 4 months to receive alternative condition if desired. Hypothesize that limb pain intensity will be significantly decreased following cryoneurolysis procedure. Also there will be improvement in subjective well-being, physical and emotional functioning and decrease in depression.
• 0 patients enrolled at NMCSD- awaiting approval from DHA
• Continuous Peripheral Nerve Block UCSD 171102 (Hackworth)
• Study name: “Improving Post-Amputation Functioning by Decreasing Phantom Limb Pain and Opioid Use with Perioperative continuous Peripheral Nerve Blocks: A Multicenter RCT”
• Conducted at NMCSD in collaboration with UCSD
• The purpose of this study is to investigate whether or not he use of a continuous peripheral nerve block can decrease the likelihood and intensity of phantom limb pain following a lower limb amputation- uses a tiny catheter placed through the skin and next to the nerve that goes to the amputated limb- determine if this catheter, inserted prior to surgery, will decrease phantom limb pain
• Synopsis: Investigating whether a high-concentration Continuous Peripheral Nerve Block (CPNB), as compared to a standard CPNB, improves post-amputation physical and emotional functioning while decreasing opioid consumption by preventing chronic phantom limb pain. Multi-site, triple-blind, placebo controlled clinical trial.
• 0 patients enrolled at NMCSD- awaiting approval from DHA (will receive it my beginning of April)
• Percutaneous Peripheral Nerve Stimulation UCSD 172122 (Hackworth)
• Study name: “Ultrasound-Guided Percutaneous Peripheral Nerve Stimulation: A Non-Pharmacologic Alternative for the Treatment of Postoperative Pain”
• In collaboration with UCSD
• Research subjects include those who are schedule from a shoulder, knee, foot, or ankle surgery
• The purpose of the study is to investigate whether or not the use of a peripheral nerve stimulator can decrease the likelihood and intensity of postoperative pain following surgery. A peripheral nerve stimulator is a device that applies a small amount of electrical current near your nerve closest to your surgical site. The stimulator is connected to a tiny electrical lead, which is inserted close to you nerve immediately prior to surgery. Following surgery, a tiny electric current is delivered to the nerve for several days, which may result in pain control without any medication
• 0 enrolled at NMCSD
• Study is open to enrollment, but COVID-19 has prohibited this
• Melatonin NMCSD.2015.0048 (Fisher)
• Study name: “Predication with melatonin vs Placebo in Patients Undergoing Interventional pain Procedure”
• Synopsis: Designed to evaluate the efficacy of melatonin for reducing anxiety in patients undergoing lumber medial branch block procedure. Medial branch block procedures are used as diagnostic tools for chronic low back pain. Randomized, double-blinded, placebo-controlled trial.
• The purpose is to learn about how melatonin can help decrease anxiety in patients before having an LMBB procedure- patients receive 2mg melatonin, 10 mg melatonin, or placebo and fill out anxiety questionnaires
• Local Enrollment: 20/63
• NMC Portsmouth is in the process of being added as a site
• Ketamine NMCSD.2019.0074 (Phillips)
• Study name: “The impact of outpatient ketamine infusions on pain patients with psychiatric comorbidities: a prospective observational pilot study”
• Enrolled: 1/60
• Purpose: to learn about the effects of ketamine infusion treatment for pain on mental health conditions.
• Pain, Sleep, & Work NMCSD.2019.0073 (McChesney/Ransom)
• Protocol submitted on 02/25- not approved, not open to enrollment
• Study name: “Associations between Pain and Sleep Disruption on Work Performance in the Military”
• Purpose: to examine the associations between chronic pain and sleep disruption in the context of work performance among active duty service members
• Data will be obtained via questionnaires

2. QUALITY IMPROVEMENT PROJECTS

a. PASTOR data possibilities – NMCSD.QI.2020.021901 (Espejo)
• Study: Pastor PLUS
• A QI study (Quality improvement) that will provide population-based actionable data and facilitate patient and provider clinical interactions with pain-specific clinical data- expected outcome will be more consistent pain treatment and greater accuracy in modeling requirements for pain medicine- also a patient and provider satisfaction survey that will help monitor and forecast user satisfaction ratings, barriers to implementation, and recommendations for successful implementation for wider use
• Posters presented at AAPM
• Poster submitted for ARC
b. Pain and Behavioral Health NMCSD.QI.2018.0014 (Fowler/Espejo)
• Data collection completed/on hold
• Designed to evaluate patients of the Pain Management Clinic of NMCSD who are receiving pain interventions at the 32nd Street Naval Base clinic. Interventions include Mind Body Medicine and Cognitive Behavioral Therapy for Insomnia. Patient treatment response will be evaluated via self-report questionnaires throughout treatment and will be continuously examined to provide immediate feedback as to whether interventions are producing the desired effects. Ongoing modifications will improve outcomes. Outcome measures will be primarily collected via PASTOR.
• Similar to PASTOR PLUS
• AAPM poster
• ARC submitted
• Honestly not sure what the difference between a and b are for the QI projects
c. Vasovagal (Hackworth)
• Study name: Vasovagal QI 2018
• Investigation into potential predisposing factors of vasovagal syncope with aim of decreasing vagal episodes. All patients are asked to fill out a one-page questionnaires before all procedures to determine if there are demographic factors leading to vagal episodes. If patient experiences syncope, then additional follow-up questions are asked related to procedure and time of syncope occurrence. Identification of risk factors would lead to proper intervention of at risk patients.
• Data collection and entry complete, in process of receiving stats information. All 1781 forms entered into database
• Data analysis – Dr. Greene
• May present for QI fair