Oral, Topical, and Behavioral Treatments for Diabetic Neuropathy
(MCPAIN Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores new methods to help individuals with painful diabetic neuropathy, which is nerve pain from diabetes. Researchers aim to evaluate the effectiveness of various treatments, including oral medications, topical medications (applied to the skin), and cognitive behavioral therapy (a type of talk therapy). Participants who do not experience improvement after the first four months will switch to a different treatment method for another four months. Individuals with diabetes and nerve pain who are willing to try different treatments might be suitable for this trial. As a Phase 4 trial, the treatments are already FDA-approved and proven effective, allowing researchers to understand how they benefit more patients.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What is the safety track record for these treatments?
Research has shown that cognitive behavioral therapy (CBT) is generally safe and well-tolerated. It has been used successfully for various mental health issues, with studies reporting no major safety concerns.
For oral medications treating painful diabetic nerve damage, specific safety data is not mentioned. However, the study's later phase suggests earlier trials found the treatment safe.
Topical medications, such as lidocaine patches, tend to have fewer and milder side effects compared to systemic treatments. Studies indicate they are generally well-tolerated, with fewer negative reactions.
In summary, CBT is safe, oral medications are likely well-tolerated due to the trial's advanced stage, and topical treatments have minimal side effects.12345Why are researchers enthusiastic about this study's treatments?
Researchers are excited about these treatments for diabetic neuropathy because they combine traditional and innovative approaches, offering new possibilities for managing this challenging condition. Unlike standard treatments that primarily focus on oral or topical medications, this trial includes Cognitive Behavioral Therapy (CBT), which addresses pain perception and coping strategies, potentially reducing pain without relying solely on drugs. The trial's adaptive approach, re-randomizing non-responders to different treatments, allows for personalized care and could lead to more effective interventions tailored to individual needs. This comprehensive method could transform how we manage diabetic neuropathy by integrating behavioral therapies with conventional medical treatments.
What evidence suggests that this trial's treatments could be effective for diabetic neuropathy?
Research has shown that Cognitive Behavioral Therapy (CBT), one of the treatments in this trial, can help reduce pain for people with diabetic neuropathy. Four months after starting CBT, participants reported less pain and noted it interfered less with their daily activities. Oral medications, another treatment option in this trial, play a crucial role in controlling blood sugar levels, which is key to managing diabetic neuropathy symptoms. The trial also studies topical treatments, like 5% lidocaine cream, which have effectively relieved pain for many patients. A good result with these creams often means a 30-50% reduction in pain, with more than 50% considered very successful.678910
Who Is on the Research Team?
Brian Callaghan, MD
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
This trial is for adults (18+) with painful diabetic nerve damage, including those with diabetic kidney disease. Participants must have ongoing pain from diabetes and be able to take part in an 8-month study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Stage 1
Participants receive one of three modalities (oral, topical, behavioral) for initial PDN treatment
Treatment Stage 2
Non-responders are re-randomized to a new treatment modality; responders continue with the same modality
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Cognitive Behavioral Therapy (CBT)
- Oral Medication
- Topical Medication
Trial Overview
The study compares three treatments for painful diabetic neuropathy: oral medication, topical medication applied to the skin, and cognitive behavioral therapy. If a treatment doesn't work after 4 months, participants may switch or continue as part of the research design.
How Is the Trial Designed?
12
Treatment groups
Experimental Treatment
Participants randomized to topical medications, and are considered responders at 4 months will continue with the same topical medication for the next 4 months.
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.
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.
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.
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.
Participants randomized to oral medications, and are considered responders at 4 months will continue with the same oral medication for the next 4 months.
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.
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.
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.
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.
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Citations
Cognitive Behavioral Therapy Delivered Via Smartphone ...
Digital CBT also had a positive effect on patient-reported outcomes, including depression and quality of life scores over six months, he said.
2.
researchoutput.csu.edu.au
researchoutput.csu.edu.au/en/publications/the-efficacy-of-cognitive-behavioral-therapy-based-intervention-o/The efficacy of cognitive behavioral therapy-based ...
CBT was an effective treatment for diabetes patients, significantly reduced their HbA1c, FBS, DBP, depression and anxiety symptoms, and improved sleep quality.
3.
societyofclinicalpsychology.org
societyofclinicalpsychology.org/psychological-treatments-archive/cognitive-behavioral-therapy-for-depression-in-people-with-diabetes/Cognitive-Behavioral Therapy for Depression in People ...
The result is improved self-efficacy for managing diabetes self-care behaviors and acquisition of coping skills for managing both depressive symptoms and self- ...
Researchers use goal-oriented therapy to treat diabetic ...
At a four-month follow-up, participants who received CBT reported feeling less pain and reported that pain was less interfering in their daily ...
5.
researchoutput.csu.edu.au
researchoutput.csu.edu.au/en/publications/effects-of-cognitive-behavioral-therapybased-intervention-on-impr/Effects of cognitive behavioral therapy–based intervention ...
Conclusions: The findings indicate that CBT-based interventions are effective for improving glycaemic control and depression symptoms in adult ...
What is Cognitive Behavioral Therapy?
Numerous research studies suggest that cognitive behavioral therapy leads to significant improvement in functioning and quality of life.
Cognitive behavioral therapy
CBT can be a very helpful tool in treating many mental health conditions, such as depression, anxiety, post-traumatic stress disorder, also ...
Cognitive–behavioral therapy for management of mental ...
The results of several randomized controlled trials indicated that CBT was effective for a variety of mental problems (e.g., anxiety disorder, ...
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