Modality Choice Before and After Failure for The Treatment of PAINful Diabetic Neuropathy (MCPAIN)
PI(s): Brian Callaghan, M.D., M.S. (University of Michigan, Neurology)
Purpose: Painful diabetic neuropathy (PDN) affects about 1 in 5 people with diabetes, and the number of people affected is expected to increase as diabetes becomes more common. Several treatment options are available, including medications taken by mouth, topical treatments applied to the skin and behavioral approaches, but there is limited evidence comparing how well these options work against each other.
This PCORI-funded patient-centered CER project will compare which modality (oral, topical or behavioral) is the most effective and tolerable initial treatment for PDN. For individuals who do not find relief, this study will also explore whether it is more effective and tolerable to switch to a different treatment within the same modality or to switch to a different type of treatment altogether.
Study Design: Sequential, multiple assignments, randomized trial design
PCORnet® Partners:
- Allina Health, Vasudha Goel, MBBS, MS
- Baylor Scott & White University Medical Center, Dana Bleakney, MD
- Columbia University, Thomas Brannagan, MD
- DHR Health Institute for Research and Development, Marcel Twahirwa, MD
- Duke University, Ranee Chatterjee, MD, PhD
- Essentia Health, Stephen Rostad, MD
- Mayo Clinic Rochester, Kamal Shouman, MD
- Meharry Medical College, Nandakumar Bangalore Vittal, MD
- Oregon Health & Science University, Rodica Busui MD PhD
- Stanford Medicine, Dong-In Sinn, MD
- Tulane University, Vivian Fonseca, MD
- University of Florida, Jacksonville, Joe Chehade, MD
- University of Iowa, Marcelo Correia, MD, MSc, PhD
- University of Minnesota, Pitcha Chompoopong, MD
- University of Missouri- Columbia, Benjamin Crenshaw, MD
- University of Nebraska Medical Center, Cyrus Desouza, MBBS
- University of North Carolina, Chapel Hill, Laura Young, MD, PhD
- Vanderbilt University Medical Center, Amanda Peltier, MD
- Weill Cornell Medicine, Lisa R. Witkin, MD
PaTH Partners:
- Brian Callaghan, MD, MS Study PI, Lead Site (University of Michigan)
- Lynn Ang, MBBS (University of Michigan)
- Holly Thomas, MD (University of Pittsburgh)
- Eva Tseng, MD, MPH (Johns Hopkins University)
- Rabia Malik, MD (Rush University Medical Center)
Sponsor: PCORI®
The MCPAIN study is a PCORnet® Study conducted using PCORnet®, the National Patient Centered Clinical Research Network, an initiative funded by the Patient-Centered Outcomes Research Institute (PCORI). More information about PCORnet® can be found here.
The MCPAIN study was funded by PCORI through PCORI Award BPS-2025C2-45514.
The statements presented on this website are solely the responsibility of the author(s) and do not necessarily represent the views of other organizations participating in, collaborating with, or funding PCORnet or of PCORI.
Coordinating Center: University of Michigan
How to participate: Contact us at Contact-MCPAIN@umich.edu.
