In 2012, Jennifer Stevens-Lapsley, PT, PhD, FAPTA, helped people recovering from total knee replacement surgery recover faster. Using a career development award, she demonstrated that neuromuscular electrical stimulation significantly improved muscle strength in the quadriceps after surgery.
In fact, the study demonstrated a near double speed of recovery, showing improved functional outcomes, such as standing up from a chair, walking a set distance and climbing stairs with greater speed and ease.
Despite the study’s demonstrated effectiveness, it was not widely disseminated. Stevens-Lapsley, professor of physical therapy at the University of Colorado School of Medicine, learned that no matter how effective an intervention is, there can be a lack of widespread adoption.
That’s when she turned to implementation science, which is the study of methods to promote the adoption and integration of evidence-based practices, policies, and interventions in real-world settings. With support from the many educational opportunities and investigators at the Adult and Child Center for Outcomes Research and Delivery Science (ACCORDS), she explored the methodology necessary for conducting an implementation science study for this intervention.
“As we gained expertise in implementation science, we realized there was an opportunity to demonstrate how this intervention could be scaled up. We wanted to evaluate whether it was feasible to implement it in real-world settings, clinic by clinic,” Stevens-Lapsley says.
Clinical Trial Aims to Improve Outcomes with Neuromuscular Stimulation
Stevens-Lapsley and her co-investigators, Michael Bade, PT, DPT, PhD, associate professor of physical therapy, Jeri Forster, PhD, associate professor of physical medicine & rehabilitation, and Dan Matlock, MD, MPH, professor of medicine and director of the Colorado Program for Patient-Centered Decisions at ACCORDS, recently received RO1 funding from the National Institutes of Health (NIH).
The research project grant will allow them to conduct a clinical trial involving 30 clinics in partnership with UCHealth and Intermountain Health. The Colorado and Utah-based clinics will be randomized, with 15 receiving the usual care and 15 receiving neuromuscular electrical stimulation.
Patients in the intervention will be trained to use a portable stimulator device before surgery. This involves attaching electrodes to the quadricep muscle so the device can send electrical impulses, causing the muscle to contract.
Stevens-Lapsley said that muscle contraction becomes especially important after surgery.
“Knee surgery itself doesn’t damage the quadriceps, but swelling and trauma trigger a protective response that shuts the quadriceps muscle down,” Stevens-Lapsley explains. “For example, before surgery, a patient lying in bed can lift their leg off the bed while keeping the knee straight—a movement known as a straight leg raise. The day after surgery, most patients find this nearly impossible.”
Neuromuscular electrical stimulation helps keep the muscle active until it’s ready to contract again as the swelling from surgery subsides.
The Importance of Strong Quadriceps
After knee surgery, surgeons often focus on range of motion as the gold standard for recovery. Range of motion is important to perform basic activities, such as climbing stairs and standing up from a chair. But Stevens-Lapsley said there’s no clear correlation between range of motion and overall function. In contrast, there is a strong and well-documented connection between muscle strength and overall physical function.
“We’ve been working— and continue to work—on educating patients and the surgical community that range of motion isn’t the only outcome to prioritize,” Stevens-Lapsley says. “Muscle strength plays a much larger role in achieving long-term independence and preserving functionality in the home and other settings.”
Understanding the Barriers to Implementation
The project is working to assess the feasibility of the intervention from a range of perspectives.
“Our goal is to speed up recovery, but we’re aware that the added workload and complexity could deter surgeons from recommending it,” Stevens-Lapsley says.
Clinicians may be hesitant to implement this process due to the time it takes to secure the devices, receive insurance approvals and teach patients to use the device. Their staff will also be asked to troubleshoot any issues.
They also share concerns about the patient experiences, which Stevens-Lapsley admitted has varied. While most people tolerate it, some find the experience uncomfortable.
“To be honest, in the 25 years I’ve been using neuromuscular electrical stimulation, I still can’t predict who will tolerate it well and who won’t. It’s complex, and the only way to know is to try it and see how someone reacts,” Stevens-Lapsley says.
The team is planning to include in this project surveys and other tools that may help identify factors that could predict how well the patient will tolerate the intervention.
Considering the Financial Feasibility
As with any new therapy, cost is a key consideration. Each unit costs approximately $300, with replacement electrodes priced at $10 each. The team envisions healthcare systems owning a pool of devices that could be rented to patients at a subsidized rate.
Stevens-Lapsley says that in population healthcare systems, this therapy could potentially reduce overall costs by minimizing the number of outpatient physical therapy sessions required. It may also benefit employers by shortening the time employees are out of work.
“There’s also the bundled payment model for joint replacements, which provides a fixed amount per patient,” Stevens-Lapsley explains. “In this model, providers must manage resources carefully. A home-based unit that speeds recovery and reduces the need for in-person visits could lead to significant cost savings.”
Most knee surgeries are performed on patients over the age of 50, with Stevens-Lapsley’s previous research focusing on an average age of 65. She acknowledges that for the intervention to be covered by Medicare, the evidence must be compelling enough to influence reimbursement decisions.
“That’s the ultimate goal,” Stevens-Lapsley says.
Building a Bridge from Research to Practice
The study will last five years, with the intervention phase expected to take two and a half to three years. Currently, they are focused on ensuring a seamless flow of information in the electronic health records and establishing workflows needed for implementation.
After studying joint replacement for more than 25 years, Stevens-Lapsley is grateful for the chance to bridge a gap in her work.
“It is certainly a wonderful opportunity to come full circle. We did this work over a decade ago, and now we have a chance to see it translate into real-world practice,” she says.
