OREF grant recipient assesses efficacy of a video-delivered skills intervention
Although acute pain is a normal part of recovery after musculoskeletal injury, it is less clear why some patients fully recover while others continue to experience pain and disability months and years after the initial event. A growing body of evidence demonstrates that psychosocial factors explain at least some of the transition from acute pain to chronic pain and disability.
A collaborative biopsychosocial model that addresses both the patient's injury and coping skills may provide strategies to identify patients at risk of chronic pain and to improve outcomes in pain management and function. Ana-Maria Vranceanu, PhD, associate professor of psychology at Harvard Medical School, and director of Behavioral Health Integration at Massachusetts General Hospital (MGH), is conducting a randomized, controlled clinical trial to assess whether a psychosocial intervention that she developed called "The Toolkit for Optimal Recovery," delivered through secure live video, decreases pain and increases physical functioning more than standard care in patients with acute musculoskeletal trauma.
The study is funded by a 2015 Orthopaedic Research and Education Foundation (OREF) Prospective Clinical Research Grant, which provides up to $50,000 for 3 years. Dr. Vranceanu's research collaborators include David C. Ring, MD, PhD; Mark S. Vrahas, MD; and the orthopaedic trauma team at MGH.
Thinking about pain
The importance of psychological factors in pain management and recovery is evident in their predictive value for chronic pain and disability, according to Dr. Vranceanu. "Our work has shown that catastrophic thinking about pain and anxiety due to pain sensations are important modifiable factors prospectively associated with pain and disability, even after controlling for the severity of the initial injury," she explained. "These factors are also associated with higher opioid intake, which is also a predictor of disability after orthopaedic trauma.
"Some anxiety about pain is common after an injury and it is initially protective—you do want to be careful in the initial post-injury or post-surgery period," she added. "However, for individuals with pain anxiety, the level of protection becomes magnified and takes over. These individuals experience intense physiological anxiety triggered by pain and negative pain thoughts, and get set into a pattern characterized by avoidance of any activities that might cause pain. Because they pay more and more attention to their pain and injury, their personal lives get smaller and their pain and disability take over. They also ask for more opioid prescriptions and may be at risk for additional surgeries."
The goal of Dr. Vranceanu's research is to provide nonpharmacologic interventions that reduce pain and disability among high-risk patients. "The data showed an unexplored opportunity to improve recovery in the acute phase, when patterns of thinking and behaviors are more malleable and treatment is generally more effective. We needed to develop a program that would be brief, skills-oriented, scalable, and non-stigmatizing for patients or providers," she said.
Dr. Vranceanu and her team tested the Toolkit on patients in person but noted that one barrier to implementation was travel. Their solution was to deliver the Toolkit through a secure, live video platform.
The Toolkit for Optimal Recovery is a four-session program that combines principles from two evidence-based approaches: cognitive behavioral therapy (CBT) and relaxation response theory. Patients receive a treatment manual and participate at their convenience in the following four sessions:
- Session 1: Participants receive an introduction to the program and set recovery goals that are realistic and specific.
- Session 2: Participants learn about the CBT model for pain, and the interrelation between their own nonadaptive pain thoughts, emotions, behaviors, and physical sensation.
- Session 3: Participants learn to work through things that they can control versus things that they can't control and use acceptance and emotional coping to manage uncertainty.
- Session 4: Participants learn to use activity pacing to foster return to activities that involve the injured body part.
Trial design for psychosocial interventions
Dr. Vranceanu and her colleagues hope to recruit 172 patients who received treatment for musculoskeletal trauma who are determined to be at risk of chronic pain and disability. The determination will be based on pain catastrophizing and pain anxiety scores at 1- to 2- month follow-up. Patients will be randomly assigned to either a control group receiving standard medical treatment or a group that receives standard medical treatment plus the Toolkit intervention.
Before and after the intervention, patients will complete an online battery of validated questionnaires to assess musculoskeletal function, pain intensity, depression, posttraumatic stress disorder, pain catastrophizing, and pain anxiety.
One aim of the study is to determine whether the video delivery is accepted by patients and whether it is feasible. The researchers will judge acceptability by assessing multiple factors related to those who agreed to participate as well as those who declined. They will also get direct feedback from patients in terms of their satisfaction with the program. Feasibility will be judged based on data about completion rates.
A second aim is to determine whether the intervention results in better scores for physical function and pain. Additionally, Dr. Vranceanu and her research team will assess whether improvements in pain and physical function occur because of decreased levels of pain catastrophizing and pain anxiety.
OREF support for psychosocial research
Dr. Vranceanu noted that positive outcomes could readily translate to improved interventions for orthopaedic care. She explained, "A new care model that considers the coping skills of patients and psychological factors has the potential not only to improve recovery, but also to reduce the use of narcotics and repeat surgeries."
Dr. Vranceanu believes that the Toolkit is an excellent resource for both patients and orthopaedic surgeons and has applied for additional funding from OREF to develop a step-care model that will provide all patients with an educational video on pain management that sets up realistic expectations about injury and recovery. Next, those who are at risk for opioid misuse and chronic pain will be randomized to the Toolkit or usual medical care.
"We are incredibly grateful to OREF for funding our research. Our goal is to secure National Institutes of Health funding to implement the Toolkit and our step-care model through multisite trials, to reduce suffering, decrease risk for opioid misuse, and improve recovery after orthopaedic injuries," said Dr. Vranceanu.
Jay D. Lenn is a contributing writer for OREF. He can be reached at email@example.com © Orthopaedic Research and Education Foundation (OREF)