Grants We Funded

Abstract

Project Summary: Plain Language Health-Relatedness Summary: Carpal tunnel syndrome (CTS) is a common upper extremity condition associated with debilitating numbness, tingling, and loss of function in the hand and fingers. Cannabidiol (CBD) is a component of cannabis that does not cause a high or addiction but has been shown to alleviate pain and inflammation. CBD is presently used over-the-counter by patients with CTS for symptom relief, but to date no clinical evidence of efficacy has been published. We seek to determine the safety, feasibility, and efficacy of CBD as a treatment for CTS. Rationale and Objectives: Pre-clinical data and clinical trials of patients with lower extremity peripheral neuropathy demonstrate a favorable effect of CBD for relief of neuropathic pain symptoms. CBD is currently being used over-the-counter by patients for the treatment of CTS symptoms. Our objective is to collect provisional safety, feasibility, and efficacy data of CBD for the treatment of CTS. This will serve as the preliminary data for a NIH R61/33 application to study the efficacy of CBD as a topical treatment for CTS. Aims and Hypothesis: We aim to determine the safety of topically-applied CBD (Aim 1). Additionally, we aim to determine the feasibility of topically-applied CBD (Aim 2-Task 1) in terms of willingness to undergo randomization, medication compliance, and follow-up retention and provisional efficacy (Aim 2-Task 2) for reduction of CTS symptom severity to provide an effect size estimate. We hypothesize that topical CBD application will be safe, feasible, and will reduce the neuropathic symptoms associated with CTS. Research Design: In aim 1, we will conduct a safety clinical trial of topical application of CBD in normal healthy subjects. In aim 2, we propose a double-blind, randomized controlled trial with topical application of control or CBD followed by crossover to the other condition to assess metrics of feasibility and efficacy.

Impact Statement: Carpal tunnel syndrome is the most common compressive neuropathy, associated with significant pain, disability, lost time from work, and reduced quality of life. Though carpal tunnel release is an effective operative option, many patients are unwilling or unable to undergo surgery. Despite a lack of clinical evidence and in search of additional nonoperative treatments, many patients with CTS are using CBD. The proposed study seeks to collect data on the therapeutic potential of CBD for the alleviation of neuropathic pain related to CTS. Data derived from this research may provide a potential paradigm shift for the treatment of CTS and may likely be extrapolated to neuropathy globally. We seek pilot clinical evidence to inform follow-on funding for an NIH R61/R33 grant.

Biography
Dr. DeGeorge graduated summa cum laude from The College of William and Mary and attended Jefferson Medical College and Thomas Jefferson University where he completed his medical education and a Ph.D. in Molecular Pharmacology and Structural Biology. He then completed his residency training in the Department of Plastic Surgery at the University of Virginia. Dr. DeGeorge went on to complete fellowship training in Hand and Microvascular Surgery in the Department of Orthopaedic Surgery at the Mayo Clinic. He returned to the University of Virginia to join the faculty at the UVA Hand Center. Dr. DeGeorge’s areas of expertise include brachial plexus and peripheral nerve surgery and hand, wrist, and forearm reconstruction following trauma. He also specializes in microsurgery and arthroscopy of the upper extremity. His research interests include clinical trial design and outcomes research, complementary and alternative health interventions, articular cartilage repair and replacement techniques, and allograft tendon, cartilage, and dermis studies. Dr. DeGeorge has received additional training in clinical trial design and research methodology. He has received numerous awards for his research and academic excellence.