CCTR provides researchers with valuable resources
When Dan Riddle, Ph.D., was awarded a $5 million grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases within the National Institutes of Health, he reached out to the VCU Center for Clinical and Translational Research for its research resources, specifically the Clinical Research Services and Biomedical Informatics Core for his Phase III randomized clinical trial.
“Once the funding came through, I needed to begin the process of staffing. I needed a superb study coordinator, so I called [CCTR director] Dr. Clore. I worked very closely with the Clinical Research Services staff to identify a study coordinator,” said Riddle. “Megan Miller joined the project as the study coordinator and she has been phenomenal.”
Riddle is studying pain interventions for patients following knee arthroplasty. Approximately 25 percent of patients have disabling pain following apparently successful arthroplasty surgery. Recent research suggests that pain catastrophizing plays a key role in determining which patients with knee arthroplasty have a poor outcome. Pain catastrophizing is a mental health construct that occurs when patients feel helpless in dealing with pain and simply can’t stop thinking about the pain.
“We are testing the effectiveness of a pain coping skills intervention as compared to arthritis education or the standard treatment of care for patients undergoing knee replacement surgery,” said Riddle.
According to Riddle, substantial literature suggests that pain coping skills training is effective for patients with chronic pain but the intervention has not been studied for surgical patients with severe arthritic knee pain.
“We designed the Knee Arthroplasty pain coping Skill Training (KASTpain) trial to address the research need. The Phase III three-arm randomized clinical trial seeks to combine a strong and diverse group of researchers to examine an important and understudied area in the joint arthroplasty literature,” Riddle said.
The clinical trial has two specific aims: determining if a pain coping skills training intervention provided by physical therapists is more effective at reducing pain, improving function and is more cost effective than arthritis education or usual care; and determining if changes in pain and function following pain coping skills training are mediated by changes in pain catastrophizing.
“We expect that the study will have a substantial impact on clinical practice by providing evidence in support of a new treatment paradigm: a perioperative pain coping skills training approach delivered by physical therapists for knee arthroplasty patients at-risk for poor outcome,” said Riddle.
This is a multi-site clinical trial. The sites include VCU, Duke, Southern Illinois and Wake Forest. The sites began screening patients in December 2012 with recruitment beginning in January 2013. Recruitment of patients for the clinical trial will continue for the next two-and-a-half years.
At VCU, the lead site, the CCTR CRS staff members are delivering the arthritis education portion of the clinical trial as well as conducting physical performance tests on the patients.
“In addition to consenting and recruitment managed by the CRS, I needed to have an infrastructure and designated place for the trial. This is a really important and efficient way to get the study going and on track,” said Riddle. “The CCTR provided the resources and offered exactly what I needed to move forward with the clinical trial.”
Another important research resource provided to Riddle by the CCTR was its Biomedical Informatics services.
“Brian Bush with the Biomedical Informatics Core has done a spectacular job of building a state-of-the-art platform using REDCap to guide electronic data collection. At literally a moment’s notice, I can see what’s happening at all four clinical trial sites. This gives us the power to address any issues that arise. It is an extremely important benefit to have the Biomedical Informatics Core as a resource available at VCU,” said Riddle.
For more information about CCTR research resources, visit http://www.cctr.vcu.edu