Diabetic Nephropathies, Painful Diabetic Neuropathy (PDN)
Conditions
Brief 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.
Interventions
DEVICECognitive 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).
DRUGOral 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
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)
Sponsors
University of Michigan
Patient-Centered Outcomes Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
a comparative-effectiveness sequential, multiple assignment, randomized trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-centered utility function as a measure for efficacy and tolerability | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | 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. |
| Pain interference | 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. |
| Discontinuation | Up to 8 months | Rate of treatment discontinuation for any reason, including withdrawal From enrollment to end of treatment at 8 months. |
| Related adverse events | Up to 8 months. | Adverse events reported by local sites and determined to be related to the treatment. |
| Physical functioning/Quality of Life (QOL) | 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" |
| Neuropathy specific QOL | 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. |
| Depression | 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. |
| Anxiety | 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. |
| Sleep | 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. |
| Pain Catastrophizing | 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" |
| Global treatment satisfaction | 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". |
| Substance use screener | 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". |
Countries
United States
Contacts
CONTACTFallon Koenig, MS, CCRP
PRINCIPAL_INVESTIGATORBrian Callaghan, MD
University of Michigan
Outcome results
None listed