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NCT Number: NCT07795593

Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy

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.

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Key information

Conditions

Painful Diabetic Neuropathy (PDN) Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Diabetic Neuropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University, Stanford, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diabetes
  • Painful Diabetic Neuropathy (confirmed at screening visit)
  • Willing to accept random treatment assignment to any of the proposed interventions

Exclusion criteria

  • Pregnancy or plans to become pregnant during the study
  • History of neuropathy from causes other than diabetes as determined through medical and family history, physical and neurologic examinations
  • HbA1c >10%
  • Participation in an experimental medication trial within 3 months of starting the study
  • Undergoing therapy for malignant disease other than basal-cell or squamous-cell skin cancer
  • Medical or psychiatric reason for not being a study candidate according to the site PI's discretion
  • Contraindications preventing trialing two interventions within any of the 3 modalities
  • Cirrhosis of the liver

Treatment and study plan

Cognitive Behavioral Therapy (CBT)

Device

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

Drug

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

Drug

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)

Primary outcomes

  1. Patient-centered utility function as a measure for efficacy and tolerability

    Time frame: Up to 8 months.

    Efficacy and tolerability will be assessed and measured as utility function. Utility function ranges from 0-1.75, 0 being the lowest utility function and 1.75 being the highest utility function. Utility function that is a composite of efficacy (0-1) and discontinuation (0-1).

Secondary outcomes

  1. Pain intensity

    Time frame: Up to 8 months.

    Pain intensity as measured by first question of the "Pain, Enjoyment, General Activity" (PEG) numeric rating scale, where a score of 0 is no pain and 10 is the worst pain imaginable.

  2. Pain interference

    Time frame: Up to 8 months.

    Pain interference as measured by the sum of the second two questions of the "Pain, Enjoyment, General Activity" (PEG) numeric rating scale, where a score of 0 is no interference with daily life and 20 is the complete interference with daily life.

  3. Discontinuation

    Time frame: Up to 8 months

    Rate of treatment discontinuation for any reason, including withdrawal From enrollment to end of treatment at 8 months.

  4. Related adverse events

    Time frame: Up to 8 months.

    Adverse events reported by local sites and determined to be related to the treatment.

  5. Physical functioning/Quality of Life (QOL)

    Time frame: Up to 8 months.

    Physical function/QOL as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical functioning Short Form 6b, a 5 question questionnaire. Each question is measured with a likert scale, where 5 is "without any difficulty" and 1 is "unable to do"

  6. Neuropathy specific QOL

    Time frame: Up to 8 months

    Neuropathy Quality of Life (NeuroQOL) evaluates symptoms and function in regard to quality of life over the past four weeks. Range 1-15, higher score indicates neuropathy having a greater impact on quality of life.

  7. Depression

    Time frame: Up to 8 months

    As measured by the Patient Health Questionnaire (PHQ-2), a two-question questionnaire where each depression symptom is scored on a scale of 0-3, where 0 is "not at all" and 3 is "nearly every day". The total score range is 0-6 where the higher score indicates more depression symptoms.

  8. Anxiety

    Time frame: Up to 8 months

    As measured by the General Anxiety Disorder (GAD-2), a two-question questionnaire where each anxiety symptom is scored on a scale of 0-3, where 0 is "not at all" and 3 is "nearly every day". The total score range is 0-6 where the higher score indicates more anxiety symptoms.

  9. Sleep

    Time frame: Up to 8 months

    Sleep Quality represented by the sum of scores on the PROMIS Sleep Disturbance 6a and an additional question regarding sleep duration.

  10. Pain Catastrophizing

    Time frame: Up to 8 months

    As measured by the Pain Catastrophizing Scale Short Form 6, where a score of 0 is catastrophizing "not at all" and 52 is catastrophizing "all the time"

  11. Global treatment satisfaction

    Time frame: Up to 8 months

    As measured by Patient Global Impression of Change (PGIC), a single question on a scale of 0-6, where 0 is "very much improved" and 6 is "very much worse".

  12. Substance use screener

    Time frame: Up to 8 months

    As measured by the Tobacco, Alcohol, Prescription Medications, and other Substance (TAPS 1) questionnaire, which is five questions on a scale of 0-4, where 0 is "daily or almost daily use" and 4 is "never use".

Study contacts

Contact information is provided by the study sponsor or research team.

Fallon Koenig, MS, CCRP

CONTACT

[email protected]

734-936-8778

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

Modality Choice Before and After Failure for the Treatment of Painful Diabetic Neuropathy (MCPAIN)

Acronym: MCPAIN

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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