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

2026年8月25日 更新者：Brian Callaghan、University of Michigan

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

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.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

介入性

注册 (估计的)

600

阶段

  • 第四阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • California
      • Stanford、California、美国、94305
        • Stanford University
        • 接触：
        • 首席研究员：
          • Dong In Sinn
    • Florida
      • Jacksonville、Florida、美国、32209
    • Illinois
      • Chicago、Illinois、美国、60612
        • Rush University Medical Center
        • 接触：
        • 首席研究员：
          • Rabia Malik
    • Iowa
      • Iowa City、Iowa、美国、52242
    • Louisiana
      • New Orleans、Louisiana、美国、70118
        • Tulane University
        • 首席研究员：
          • Vivian Fonseca
    • Maryland
      • Baltimore、Maryland、美国、21224
        • Johns Hopskins University
        • 首席研究员：
          • Eva Tseng
    • Michigan
      • Ann Arbor、Michigan、美国、48104
        • University of Michigan
        • 首席研究员：
          • Lynn Ang, MD
        • 接触：
    • Minnesota
      • Minneapolis、Minnesota、美国、55455
        • University of Minnesota
        • 接触：
        • 首席研究员：
          • Pitcha Choompongpod
      • Minneapolis、Minnesota、美国、55407
        • Allina Health-Neurosciences Research
        • 接触：
        • 首席研究员：
          • Goel Vasudha
      • Rochester、Minnesota、美国、55902
        • Mayo Clinic Rochester
        • 首席研究员：
          • Kamal Shouman
    • Missouri
      • Columbia、Missouri、美国、65201
    • Nebraska
    • New York
      • New York、New York、美国、10027
        • Columbia University
      • New York、New York、美国、10065
        • Will Cornell Medicine
        • 接触：
        • 首席研究员：
          • Lisa Witkin
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
      • Durham、North Carolina、美国、27708
    • Oregon
      • Portland、Oregon、美国、97239
        • Oregon Health & Science University
        • 首席研究员：
          • Rodica Busui
        • 接触：
    • Pennsylvania
      • Titusville、Pennsylvania、美国、16354
        • University of Pittsburgh
        • 接触：
        • 接触：
        • 首席研究员：
          • Holly Thomas
    • Tennessee
      • Nashville、Tennessee、美国、37208
        • Meharry Medical College
        • 接触：
      • Nashville、Tennessee、美国、37235
        • University of Vanderbilt
    • Texas
      • Edinburg、Texas、美国、78539
        • DHR Health Institute for Research and Development
        • 接触：
        • 首席研究员：
          • Marcel Twahirwa
      • McKinney、Texas、美国、75071
        • BaylorScott & White University Medical Center
        • 接触：
        • 首席研究员：
          • Dana Bleakney
    • Wisconsin

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：交叉作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Oral Medication then New Oral Medication
Participants randomized to oral medications, and are considered non-responders at 4 months will be rerandomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to oral medications will select a new oral medication for the next 4 months.
药品：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
实验性的：Oral Medication then Same Oral Medication
Participants randomized to oral medications, and are considered responders at 4 months will continue with the same oral medication for the next 4 months.
药品：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
实验性的：Oral Medication then Topical Medication
Participants randomized to oral medications, and are considered non-responders at 4 months will be rerandomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to topical medications will select a topical medication for the next 4 months.
药品：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

药品：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)
实验性的：Oral Medication then Cognitive Behavioral Therapy
Participants randomized to oral medications, and are considered non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to a behavioral intervention will begin self-guided CBT for the next 4 months.
药品：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

设备：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).
实验性的：Topical Medication then New Topical Medication
Participants randomized to topical medications, and are considered non-responders at 4 months will be rerandomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to topical medications will select a new topical medication for the next 4 months.
药品：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)
实验性的：Topical Medication then Same Topical Medication
Participants randomized to topical medications, and are considered responders at 4 months will continue with the same topical medication for the next 4 months.
药品：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)
实验性的：Topical Medication then Oral Medication
Participants randomized to topical medications, and are considered non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to oral medications will select an oral medication for the next 4 months.
药品：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

药品：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)
实验性的：Topical Medication then Cognitive Behavioral Therapy
Participants randomized to topical medications, and are considered non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to a behavioral intervention will begin self-guided CBT for the next 4 months.
药品：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)

设备：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).
实验性的：Cognitive Behavioral Therapy then Same Cognitive Behavioral Therapy
Participants randomized to behavioral interventions will all begin with self-guided CBT. If considered responders at 4 months they will continue with self-guided CBT for the next 4 months.
设备：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).
实验性的：Cognitive Behavioral Therapy then New Cognitive Behavioral Therapy
Participants randomized to behavioral interventions will all begin with self-guided CBT. If considered non-responders at 4 months, they will be rerandomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to a behavioral intervention will begin traditional CBT for the next 4 months.
设备：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).
实验性的：Cognitive Behavioral Therapy then Oral Medication
Participants randomized to behavioral interventions will all begin with self-guided CBT. Non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to oral medications will select an oral medication for the next 4 months.
药品：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

设备：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).
实验性的：Cognitive Behavioral Therapy then Topical Medication
Participants randomized to behavioral interventions will all begin with self-guided CBT. Non-responders at 4 months will be re-randomized to a new treatment modality (oral, topical, behavioral). Those re-randomized to topical medications will select a topical medication for the next 4 months.
药品：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)

设备：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).

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Patient-centered utility function as a measure for efficacy and tolerability
大体时间：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).
Up to 8 months.

次要结果测量

结果测量
措施说明
大体时间
Pain intensity
大体时间：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.
Up to 8 months.
Pain interference
大体时间：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.
Up to 8 months.
Discontinuation
大体时间：Up to 8 months
Rate of treatment discontinuation for any reason, including withdrawal From enrollment to end of treatment at 8 months.
Up to 8 months
Related adverse events
大体时间：Up to 8 months.
Adverse events reported by local sites and determined to be related to the treatment.
Up to 8 months.
Physical functioning/Quality of Life (QOL)
大体时间：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"
Up to 8 months.
Neuropathy specific QOL
大体时间：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.
Up to 8 months
Depression
大体时间：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.
Up to 8 months
Anxiety
大体时间：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.
Up to 8 months
Sleep
大体时间：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.
Up to 8 months
Pain Catastrophizing
大体时间：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"
Up to 8 months
Global treatment satisfaction
大体时间：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".
Up to 8 months
Substance use screener
大体时间：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".
Up to 8 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Michigan

合作者

Patient-Centered Outcomes Research Institute

调查人员

  • 首席研究员：Brian Callaghan, MD、University of Michigan

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2030年8月1日

研究完成 (估计的)

2031年8月1日

研究注册日期

首次提交

2026年8月25日

首先提交符合 QC 标准的

2026年8月25日

首次发布 (实际的)

2026年8月31日

研究记录更新

最后更新发布 (实际的)

2026年8月31日

上次提交的符合 QC 标准的更新

2026年8月25日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • HUM00292431
  • BPS-2025C2-45514 (其他赠款/资助编号：Patient-Centered Outcomes Research Institute (PCORI))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Full, de-identified datasets will be deposited in a PCORI-designated repository at study completion. Study team will follow all rules and regulations of the funding agency, which can be found here: https://www.pcori.org/about/governance/pcoris-policy-data-management-and-data-sharing

IPD 共享时间框架

At the time of publication of the research project's primary results in a peer-reviewed journal - for at least 7 years

IPD 共享访问标准

A data requestor that submits a data request will be evaluated for its overall qualifications and experience (e.g., across a proposed team of specified individuals) to achieve the stated research purpose underlying the data request. Neither PCORI nor the Awardee investigators will provide technical assistance directly to data requestors. However, either party may provide input to the repository upon request.

IPD 共享支持信息类型

  • 研究方案
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

是的

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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