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Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy
Sponsor: University of Michigan
Summary
The research team will perform a comparative-effectiveness sequential, multiple assignment, randomized trial in painful diabetic neuropathy (PDN) patients for 8 total months, divided into two 4-month stages. 600 participants 18+ with PDN will be enrolled in this study. The main goal is to compare the utility of three modalities (oral, topical, and behavioral) for initial PDN treatment, and to compare the utility of switching modalities versus continuing with the same modality for non-responders. Pain and discontinuation will be assessed weekly, whereas other outcomes will be assessed monthly for 8 months.
Official title: Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy (MCPAIN)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
600
Start Date
2026-10
Completion Date
2031-10
Last Updated
2026-09-28
Healthy Volunteers
No
Interventions
Cognitive Behavioral Therapy (CBT)
Participants will work with study team to begin web-based, self-guided CBT (non-significant risk device) or traditional (one on one) CBT with a therapist (behavioral, not a device).
Oral Medication
Participants will work with their physician to select an oral medication from a list commonly used to treat PDN. Patients will follow standard of care dosing and tapering of the assigned drug. Serotonin-Norepinephrine Reuptake Inhibitors (SNRI's): Duloxetine, Venlafaxine, Desvenlafaxine Tricyclic Antidepressants (TCAs): Amitriptyline, Nortriptyline Gabapentinoids: Gabapentin, Pregabalin Sodium Channel Blockers: Oxcarbazepine, Lamotrigine, Lacosamide
Topical Medication
Participants will work with their physician to select a topical medication from a list commonly used to treat PDN. 0.075% capsaicin cream (4 times daily) 4-5% lidocaine patches (1-4 patches every 24 hours)
Locations (23)
Stanford University
Stanford, California, United States
University of Florida-Jacksonville
Jacksonville, Florida, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
Tulane University
New Orleans, Louisiana, United States
Johns Hopskins University
Baltimore, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Allina Health-Neurosciences Research
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
University of Missouri
Columbia, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
Columbia University
New York, New York, United States
Will Cornell Medicine
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University
Durham, North Carolina, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pittsburgh
Titusville, Pennsylvania, United States
Meharry Medical College
Nashville, Tennessee, United States
University of Vanderbilt
Nashville, Tennessee, United States
DHR Health Institute for Research and Development
Edinburg, Texas, United States
BaylorScott & White University Medical Center
McKinney, Texas, United States
Essentia Health
Spooner, Wisconsin, United States