The Fibromyalgia TENS in Physical Therapy (FM-TIPS) trial, designed to assess the effectiveness of adding Transcutaneous Electrical Nerve Stimulation (TENS) to standard physical therapy for fibromyalgia patients, significantly improved recruitment through targeted community engagement strategies. The trial, supported by the NIH HEAL Initiative, is examining whether TENS improves movement-evoked pain compared to physical therapy alone.
Community Engagement Strategies
Researchers from the University of Iowa, led by Heather Schacht Reisinger and Dana Dailey, implemented six community engagement strategies after receiving a diversity supplement in February 2023. By February 2022, the team had already activated 25 physical therapy clinics across seven Midwestern states. The addition of a Community Engagement Coordinator proved pivotal in enhancing trial participation.
Impact on Recruitment
The implementation of community engagement strategies led to a notable increase in inquiries about the study. Screening rates remained consistent, while enrollment rates experienced a significant boost. These positive effects were particularly pronounced in clinics that were specifically targeted for community engagement efforts. According to Dr. Dailey, clinicians reported feeling more supported and integrated into both the clinic and the broader community. Conversations with participants also provided valuable insights into their experiences outside of therapy sessions.
Addressing Challenges in Community Clinics
Clinical research within community physical therapy clinics is relatively uncommon, presenting a learning curve for many participating physical therapists. Community support played a crucial role in helping them navigate the screening and enrollment processes. The study team developed individualized clinic plans based on feedback from clinicians, which helped identify relevant organizations for collaboration and local events for outreach.
Adaptive Strategies and Documentation
Process building, including the implementation and thorough documentation of outcome measures, was essential for site evaluation. This approach allowed the research team to transfer lessons learned to lower-enrolling clinics, adapt their strategies, and implement productive changes. As Dr. Reisinger noted, engaging clinicians as community members with deep local knowledge is crucial for pragmatic trials. The intensive and responsive community engagement, facilitated by the diversity supplement, enabled the team to exceed their enrollment target, which would not have been possible otherwise. Researchers emphasize the importance of adaptability and flexibility in community engagement, even in documentation processes.
