Pain and its Treatment
The primary focus of the research being conducted by Drs. Dworkin, Gewandter, and Smith involves methodological aspects of analgesic clinical trials, especially identifying factors that might increase the assay sensitivity of a trial to detect differences between an active and a control or comparison treatment. With research funding from the FDA and industry, they are currently examining in acute and chronic pain trials the relationships between study methodological features and study outcomes, as well as comparing the responsiveness to treatment effects of different outcome measures. The overall objective of these efforts -- which are being conducted under the auspices of the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) public-private partnership with the FDA -- is to identify approaches to improving the efficiency and informativeness of clinical trials of pain treatments and provide the foundation for an evidence-based approach to analgesic clinical trial design.
Dr. Dworkin is currently conducting a randomized clinical trial of tramadol, cognitive-behavior therapy, and health education alone and in combination for the treatment of fibromyalgia in collaboration with Dennis Turk at the University of Washington. In addition, Dr. Dworkin has been very interested in the identification of risk factors for the development of chronic neuropathic pain. One of the major results of this program of research has been that patients with greater acute pain are more likely to develop chronic pain. This suggests that attenuating acute pain might prevent chronic pain, and an additional focus of his research has involved developing approaches to test this hypothesis.
In addition to her ACTTION-related work, Dr. Gewandter’s research is focused mainly on chemotherapy-induced peripheral neuropathy (CIPN). She has published results form a large randomized clinical trial (RCT) evaluating the efficacy of a topical analgesic for chronic CIPN as well as an article demonstrating that CIPN severity is associated with impaired activities of daily living. She is currently conducting a feasibility study to establish the best ways to evaluate the efficacy of a wearable TENS band for chronic CIPN and is planning an early phase efficacy study based on these results. She is also spearheading an ACTTION effort to improve the design and analysis of CIPN prevention and acute treatment trials, including conducting a systematic literature review and organizing a meeting with oncology, neurology, and statistics experts from academia and the FDA. Dr. Gewandter is also co-investigator on an RCT evaluating the efficacy of topical treatments for pain associated with radiation dermatitis.
Dr. Smith’s particular area of interest is outcome assessment. Specifically, she is currently overseeing a project to develop and qualify a measure of pain intensity through the FDA’s qualification process. This project involves qualitative analysis of patient preferences regarding pain reporting, development of the measurement tool, and quantitative testing of the tool’s cross-sectional and longitudinal measurement properties. Dr. Smith has also conducted systematic reviews of the literature that evaluate the match between a concept of interest (i.e., what you want to evaluate) and how well a given assessment tool measures that concept.
Dr. Joel Kent’s general area of research interest is in promoting symptom relief and functional restoration of patients with chronic nonmalignant pain. Within this realm, he has two focused areas of clinical interest. The first is in the critical assessment of outcomes associated with the use of chronic opioid therapy for the treatment of non-malignant pain. Opioid therapy is potentially helpful, but also carries significant potential liabilities. Despite the widespread use of opioids in this patient population, clinicians have relatively little objective medical evidence to guide their use of these agents in chronic pain patients. Thus, some of Dr. Kent’s research efforts are geared to identifying strategies to optimize this therapy and to ensure optimal outcomes when opioids are used to treat patients with chronic nonmalignant pain. He also has an interest in the treatment of neuropathic pain and has participated in studies evaluating treatments for this common condition.
Dr. Rajbala Thakur has been the principal investigator in numerous clinical studies to investigate new medications for the management of malignant and non-malignant pain conditions. These studies have included new and novel formulations of opioid medications as well as adjuvant medications for patients with neuropathic and visceral pain conditions. In addition she currently is a sub investigator in a ‘combined behavioral and analgesic trial for fibromyalgia’. More recent research work has been focused on developing clinical protocol for the use of Ketamine therapy in the treatment of intractable chronic pain conditions.