FM-TIPS, an NIH Collaboratory Trial, is studying real-world implementation of transcutaneous electrical nerve stimulation (TENS) therapy along with physical therapy to treat patients with fibromyalgia. Dr. Kathleen Sluka, Co-PI of the FM-TIPS project, and Dr. Emine Bayman, biostatistician for the project, discussed the study in an interview after the NIH Collaboratory’s annual steering committee meeting.
Sluka was excited to share an update on the project. “We are currently enrolling in the study thanks to a fantastic team,” she said. “The team has worked really hard to keep the participating clinics engaged.” With 6 healthcare systems and 30 active centers, the project has enrolled 115 patients.
The study faced several challenges during the startup phase, the biggest of which was the COVID-19 pandemic. Some of the smaller clinics participating in the study don’t have the staffing capacity to remain open when staff contract COVID-19. “When this happened,” said Sluka, “we did have significant reductions in recruitment.”
The electronic health record (EHR) has also presented challenges for the study. “Each of our healthcare systems is using different EHR systems,” said Bayman. In many clinics, the clinician or physical therapist is responsible for inputting data into the EHR. For busy healthcare staff who may not have training in the EHR system, this extra task can be difficult. The FM-TIPS project found creative ways around this challenge. Bayman said, “One of our most important exploratory outcomes was turned into a patient reported outcome. We will be collecting this data from the patients.”
Despite these challenges, FM-TIPS is making progress toward its goals and hopes to give patients with fibromyalgia more options to manage their pain on a day-to-day basis.
FM-TIPS is supported by the NIH through the NIH HEAL Initiative under an award from the National Institute of Arthritis and Musculoskeletal and Skin Diseases.