Clinical Trial at UH Defining Best Treatment Path for Knee Osteoarthritis
July 11, 2023
UH Clinical Update | July 2023
Rates of knee osteoarthritis are on the rise, with a doubling over the past 70 years and a 9.3 percent increase just since 1990. With the aging of the Baby Boomers and current growing rates of obesity in the U.S., these trends will only continue to accelerate.
To make things worse, treatment for knee osteoarthritis can be complicated, for both patients and providers. Some patients are determined to avoid surgery, despite the good outcomes it can achieve for some. Plus, guidelines for knee osteoarthritis from different organizations are sometimes not in agreement in their recommendations for psychological management, pharmacologic treatments, including opioids, and interventional therapies.
A better way: To help provide more clarity on what works best for knee osteoarthritis patients, a research team at UH is now enrolling patients in a new clinical trial, funded by the National Institute of Health’s Helping to End Addiction Long-term Initiative. The Sequenced Strategy for Improving Outcomes in People with Knee Osteoarthritis Pain (SKOAP) study, underway at between 20 and 40 sites across the U.S., is comparing widely used non-opioid pain treatments to reduce knee pain and improve knee function. In the first part of the study, participants will be treated with conservative therapies, and in the second part, they will be treated with non-surgical procedures. The researchers will also evaluate whether clinical and psychological phenotypes of knee osteoarthritis predict short and long-term treatment responses.
“There is an urgent public health need to reduce our reliance on opioids for effective long-term pain management, particularly in knee osteoarthritis,” says Marina Magrey, MD, Division Chief of Rheumatology at UH, who is leading the trial here. “This effectiveness trial will compare recommended treatments to reduce pain and functional limitations in knee osteoarthritis and identify clinical and patient-level factors associated with treatment response. These results will lead to improved patient selection for treatment and inform evidence-based guidelines by offering well-tested, effective, non-opioid alternatives.”
Dr. Magrey says this trial also builds on the pioneering research on knee osteoarthritis conducted by the late Roland Moskowitz, MD, who was Director of the Rheumatology Clinical Research Unit at UH and Professor of Medicine in the Case Western Reserve University School of Medicine.
“I embarked on this project to honor his legacy,” she says. “At UH, we are passionate about osteoarthritis research.”
Study details: The SKOAP study is being conducted in two phases. Using a stepped-care model, Phase 1 participants are randomly assigned to minimally invasive treatments, including best practices, best practices plus duloxetine, and best practices plus duloxetine combined with painTrainer, a structured pain coping skills training web-based program. Those study participants who note interest in additional treatment following completion of Phase 1, as well as those who are inappropriate for Phase 1 treatment, will be randomly assigned to more invasive procedures: intra-articular hyaluronic acid, steroid and local anesthetic injection, genicular nerve block with a long-acting local anesthetic and steroid, and radiofrequency ablation followed by steroid.
Subject participation duration will range from 15 to 48 months.
The procedure-based study team at UH includes Salim Hayek, MD, PhD, Division Chief of Pain Medicine, and Michael Schaefer, MD, Division Chief of Physical Medicine and Rehabilitation, as well as Antimo Paul Gazzillo, MD, a specialist in physical medicine and rehabilitation.
“Dr. Hayek is renowned for his pain management work and will perform a nerve procedure with long-acting blocks and ablation at the UH Ahuja facility,” Dr. Magrey says. “Dr. Schaefer and Dr. Gazillo are teaming to provide the intra-articular injections and nerve blocks at the UH Westlake facility. Also, Alysse Boyd, PA in rheumatology, has previously worked in orthopedics and is evaluating these patients both at the UH Chagrin Minoff Health Center and UH Westlake office.”
Dr. Magrey says she’s enthusiastic about the potential of this new trial to provide more and better treatment options for patients with knee osteoarthritis.
“We are able through this study to offer newer and cutting-edge options to patients who may not find relief through the standard of care,” she says. “The multidisciplinary team approach in this study will provide patient-centered and coordinated care to improve health outcomes for our patients.”